MDedge Psychiatry

A Medscape poll on clinicians’ confidence surrounding the COVID-19 vaccine for kids ages 5-11 showed significant hesitancy.

Among physician respondents who have children in that age group, 30% said they would not want their children to be vaccinated; 9% were unsure. For nurses/advanced practice registered nurses (APRNs), more (45%) said they did not want their kids to get the COVID-19 vaccine; 13% were unsure. Among pharmacists, 31% said they would not get them vaccinated and 9% were unsure.

Clinicians were more likely to want vaccinations for their kids 5-11 than were 510 consumers polled by WebMD at the same time. Overall, 49% of the consumers who had kids that age did not want them to get the COVID-19 vaccine.

On November 2, Centers for Disease Control and Prevention (CDC) Director Rochelle P. Walensky, MD, MPH, endorsed the CDC Advisory Committee on Immunization Practices’ recommendation that children 5-11 be vaccinated with the Pfizer-BioNTech pediatric vaccine. That decision expanded vaccine recommendations to about 28 million children in the United States.

The CDC states that, in clinical trials, the Pfizer vaccine had more than 90% efficacy in preventing laboratory-confirmed COVID-19 infection in children 5 to 15 years old, and that the immune response in children ages 5-15 equaled the immune response in people 16 to 25 years old.

The Medscape poll, fielded from November 3 to November 11, included 325 physicians, 793 nurses/APRNs, and 151 pharmacists.
 

How safe is the vaccine?

Clinicians were asked how confident they were that the vaccine is safe for that age group, and 66% of physicians, 52% of nurses/APRNs, and 66% of pharmacists said they were somewhat or very confident.

Among consumers overall in the WebMD poll, 56% said they were confident or somewhat confident that the vaccine is safe in that age group.

Among adolescents and young adults, rare cases of myocarditis and pericarditis in adolescents and young adults have been reported. According to the CDC, “[I]n one study, the risk of myocarditis after the second dose of Pfizer-BioNTech in the week following vaccination was around 54 cases per million doses administered to males ages 12-17 years.”

Known and potential benefits of COVID-19 vaccination outweigh the risks, including the possible risk for myocarditis or pericarditis, the CDC states.

Across clinician types, women edged out their male counterparts on confidence in the vaccine’ s safety: 71% vs 65% among physicians, 55% vs 45% among nurses/APRNs, and 68% vs 60% among pharmacists.

Among both physicians and nurses, younger physicians (under 45) tended to have greater confidence in the vaccine’ s safety: 72% vs 64% (physicians), 54% vs 51% (nurses/APRNs), and 71% vs 59% (pharmacists).

The difference in confidence was clear between vaccinated and unvaccinated physicians. All of the unvaccinated physicians who responded to the poll said they had no confidence in the vaccine for kids. Among unvaccinated nurses/APRNs, 2% were somewhat confident in the vaccine for kids under 12.
 

Knowledge about smaller dosage

The clinicians were asked about whether they were aware, before reading the poll question, that the Pfizer vaccine for children and the proposed Moderna vaccine for children in this age group (5-11) would have a different dosage.

The dose for kids 5-11 is 10 micrograms rather than 30 micrograms for people at least 12 years old. Children 5-11 receive a second dose 21 days or more after their first shot. The formulation comes with an orange cap, and a smaller needle is used.

Knowledge on the lower dose was highest among pharmacists (91% said they knew), followed by physicians (84%) and nurses (79%).

The poll also asked whether the COVID-19 vaccine should be added to the list of childhood immunizations. Responses varied widely and uncertainty was evident.

Notably, female physicians were more likely to say it should be added to the list of immunizations than were their male counterparts: 46% vs 35% (physicians), 26% vs 22% (nurses/APRNs), and 33% vs 30% (pharmacists).

A version of this article first appeared on Medscape.com.

A Medscape poll on clinicians’ confidence surrounding the COVID-19 vaccine for kids ages 5-11 showed significant hesitancy.

Among physician respondents who have children in that age group, 30% said they would not want their children to be vaccinated; 9% were unsure. For nurses/advanced practice registered nurses (APRNs), more (45%) said they did not want their kids to get the COVID-19 vaccine; 13% were unsure. Among pharmacists, 31% said they would not get them vaccinated and 9% were unsure.

Clinicians were more likely to want vaccinations for their kids 5-11 than were 510 consumers polled by WebMD at the same time. Overall, 49% of the consumers who had kids that age did not want them to get the COVID-19 vaccine.

On November 2, Centers for Disease Control and Prevention (CDC) Director Rochelle P. Walensky, MD, MPH, endorsed the CDC Advisory Committee on Immunization Practices’ recommendation that children 5-11 be vaccinated with the Pfizer-BioNTech pediatric vaccine. That decision expanded vaccine recommendations to about 28 million children in the United States.

The CDC states that, in clinical trials, the Pfizer vaccine had more than 90% efficacy in preventing laboratory-confirmed COVID-19 infection in children 5 to 15 years old, and that the immune response in children ages 5-15 equaled the immune response in people 16 to 25 years old.

The Medscape poll, fielded from November 3 to November 11, included 325 physicians, 793 nurses/APRNs, and 151 pharmacists.
 

How safe is the vaccine?

Clinicians were asked how confident they were that the vaccine is safe for that age group, and 66% of physicians, 52% of nurses/APRNs, and 66% of pharmacists said they were somewhat or very confident.

Among consumers overall in the WebMD poll, 56% said they were confident or somewhat confident that the vaccine is safe in that age group.

Among adolescents and young adults, rare cases of myocarditis and pericarditis in adolescents and young adults have been reported. According to the CDC, “[I]n one study, the risk of myocarditis after the second dose of Pfizer-BioNTech in the week following vaccination was around 54 cases per million doses administered to males ages 12-17 years.”

Known and potential benefits of COVID-19 vaccination outweigh the risks, including the possible risk for myocarditis or pericarditis, the CDC states.

Across clinician types, women edged out their male counterparts on confidence in the vaccine’ s safety: 71% vs 65% among physicians, 55% vs 45% among nurses/APRNs, and 68% vs 60% among pharmacists.

Among both physicians and nurses, younger physicians (under 45) tended to have greater confidence in the vaccine’ s safety: 72% vs 64% (physicians), 54% vs 51% (nurses/APRNs), and 71% vs 59% (pharmacists).

The difference in confidence was clear between vaccinated and unvaccinated physicians. All of the unvaccinated physicians who responded to the poll said they had no confidence in the vaccine for kids. Among unvaccinated nurses/APRNs, 2% were somewhat confident in the vaccine for kids under 12.
 

Knowledge about smaller dosage

The clinicians were asked about whether they were aware, before reading the poll question, that the Pfizer vaccine for children and the proposed Moderna vaccine for children in this age group (5-11) would have a different dosage.

The dose for kids 5-11 is 10 micrograms rather than 30 micrograms for people at least 12 years old. Children 5-11 receive a second dose 21 days or more after their first shot. The formulation comes with an orange cap, and a smaller needle is used.

Knowledge on the lower dose was highest among pharmacists (91% said they knew), followed by physicians (84%) and nurses (79%).

The poll also asked whether the COVID-19 vaccine should be added to the list of childhood immunizations. Responses varied widely and uncertainty was evident.

Notably, female physicians were more likely to say it should be added to the list of immunizations than were their male counterparts: 46% vs 35% (physicians), 26% vs 22% (nurses/APRNs), and 33% vs 30% (pharmacists).

A version of this article first appeared on Medscape.com.

A Medscape poll on clinicians’ confidence surrounding the COVID-19 vaccine for kids ages 5-11 showed significant hesitancy.

Among physician respondents who have children in that age group, 30% said they would not want their children to be vaccinated; 9% were unsure. For nurses/advanced practice registered nurses (APRNs), more (45%) said they did not want their kids to get the COVID-19 vaccine; 13% were unsure. Among pharmacists, 31% said they would not get them vaccinated and 9% were unsure.

Clinicians were more likely to want vaccinations for their kids 5-11 than were 510 consumers polled by WebMD at the same time. Overall, 49% of the consumers who had kids that age did not want them to get the COVID-19 vaccine.

On November 2, Centers for Disease Control and Prevention (CDC) Director Rochelle P. Walensky, MD, MPH, endorsed the CDC Advisory Committee on Immunization Practices’ recommendation that children 5-11 be vaccinated with the Pfizer-BioNTech pediatric vaccine. That decision expanded vaccine recommendations to about 28 million children in the United States.

The CDC states that, in clinical trials, the Pfizer vaccine had more than 90% efficacy in preventing laboratory-confirmed COVID-19 infection in children 5 to 15 years old, and that the immune response in children ages 5-15 equaled the immune response in people 16 to 25 years old.

The Medscape poll, fielded from November 3 to November 11, included 325 physicians, 793 nurses/APRNs, and 151 pharmacists.
 

How safe is the vaccine?

Clinicians were asked how confident they were that the vaccine is safe for that age group, and 66% of physicians, 52% of nurses/APRNs, and 66% of pharmacists said they were somewhat or very confident.

Among consumers overall in the WebMD poll, 56% said they were confident or somewhat confident that the vaccine is safe in that age group.

Among adolescents and young adults, rare cases of myocarditis and pericarditis in adolescents and young adults have been reported. According to the CDC, “[I]n one study, the risk of myocarditis after the second dose of Pfizer-BioNTech in the week following vaccination was around 54 cases per million doses administered to males ages 12-17 years.”

Known and potential benefits of COVID-19 vaccination outweigh the risks, including the possible risk for myocarditis or pericarditis, the CDC states.

Across clinician types, women edged out their male counterparts on confidence in the vaccine’ s safety: 71% vs 65% among physicians, 55% vs 45% among nurses/APRNs, and 68% vs 60% among pharmacists.

Among both physicians and nurses, younger physicians (under 45) tended to have greater confidence in the vaccine’ s safety: 72% vs 64% (physicians), 54% vs 51% (nurses/APRNs), and 71% vs 59% (pharmacists).

The difference in confidence was clear between vaccinated and unvaccinated physicians. All of the unvaccinated physicians who responded to the poll said they had no confidence in the vaccine for kids. Among unvaccinated nurses/APRNs, 2% were somewhat confident in the vaccine for kids under 12.
 

Knowledge about smaller dosage

The clinicians were asked about whether they were aware, before reading the poll question, that the Pfizer vaccine for children and the proposed Moderna vaccine for children in this age group (5-11) would have a different dosage.

The dose for kids 5-11 is 10 micrograms rather than 30 micrograms for people at least 12 years old. Children 5-11 receive a second dose 21 days or more after their first shot. The formulation comes with an orange cap, and a smaller needle is used.

Knowledge on the lower dose was highest among pharmacists (91% said they knew), followed by physicians (84%) and nurses (79%).

The poll also asked whether the COVID-19 vaccine should be added to the list of childhood immunizations. Responses varied widely and uncertainty was evident.

Notably, female physicians were more likely to say it should be added to the list of immunizations than were their male counterparts: 46% vs 35% (physicians), 26% vs 22% (nurses/APRNs), and 33% vs 30% (pharmacists).

A version of this article first appeared on Medscape.com.

Schizophrenia and severe mood and anxiety disorders are associated with a significantly lower risk of COVID-19 but are tied to a two- to fourfold increased risk of death from the virus, new research shows.

The study results held after the researchers controlled for other risk factors, and they contradict an earlier study that showed no increased mortality risk associated with mood or anxiety disorders. The findings come as the overall number of deaths in the United States approaches 800,000.

“These patients were less likely to be infected because they were probably less exposed, but once they have the infection, they are more prone to worse outcomes,” lead author Antonio L. Teixeira, MD, PhD, professor of psychiatry with McGovern Medical School at the University of Texas Health Science Center at Houston, said in an interview.

The study was published online Nov. 23 in JAMA Network Open.
 

Unexpected finding

Researchers analyzed electronic health records for 2.5 million adults with private health insurance who were tested for COVID-19 in 2020.

The overall positivity rate for the entire cohort was 11.91%, and patients with severe psychiatric illness fell below that rate. Positivity rates were 9.86% for people with schizophrenia or mood disorders and 11.17% among those with anxiety disorder.

Despite their lower positivity rate, patients with schizophrenia had the highest odds of death from COVID-19 after adjustment for age, race, body mass index, and comorbidities (aOR, 3.74; 95% confidence interval, 2.66-5.24).

Those results were not very surprising, Dr. Teixeira said, as earlier studies have reported similar findings. However, the data on individuals with mood and anxiety disorders were unexpected.

Patients with mood disorders were nearly three times as likely to die (aOR, 2.76; 95% CI, 2.00-3.81), and those with anxiety disorders had more than double the mortality risk (aOR, 2.34; 95% CI, 1.68-3.27).

“We were expecting some increase, but there was strong evidence in those populations as well,” he said. “We were especially surprised at the data on patients with anxiety disorders.”
 

An outstanding question

These findings contradict a study published Jan. 27, 2021, in JAMA Psychiatry, that showed no significant increase in mortality risk among those with mood or anxiety disorders.

Study methodology and timing might explain some of the differences, Katlyn Nemani, MD, a research assistant professor of psychiatry at New York University, who led that earlier study, said in an interview.

Dr. Nemani’s study had a smaller study sample, examined mortality over a 30-day period after a positive COVID-19 test, and was limited to the peak of the pandemic in New York, between March and May 2020. Dr. Teixeira’s team examined a full year of data and assessed mortality for 7 days following a positive test.

“It is possible patients with some psychiatric disorders were less likely to receive or successfully respond to treatment for severe COVD-19 which evolved during the course of the pandemic,” Dr. Nemani said, adding that it’s also possible that differences in mortality in the days following infection became attenuated over time.

While a meta-analysis published in July and reported by this news organization at that time did show higher COVID-19 mortality among patients with mood disorders, the risk was far lower than that reported in this new study. That report, which included 33 studies in 22 countries, also found no increase in risk among those with anxiety disorder.

In October, the Centers for Disease Control and Prevention added mood disorders to the list of medical conditions that increase the risk for more severe COVID-19. Schizophrenia was already on that list.

“The outstanding question is what underlies this increased risk,” Dr. Nemani said. “Future studies focused on immune-mediated mechanisms and other potential explanations will help guide targeted interventions to reduce morbidity and mortality in this vulnerable population.”

Funding for the study was not disclosed. Dr. Teixeira and Dr. Nemani report no conflicts of interest.

A version of this article first appeared on Medscape.com.

Schizophrenia and severe mood and anxiety disorders are associated with a significantly lower risk of COVID-19 but are tied to a two- to fourfold increased risk of death from the virus, new research shows.

The study results held after the researchers controlled for other risk factors, and they contradict an earlier study that showed no increased mortality risk associated with mood or anxiety disorders. The findings come as the overall number of deaths in the United States approaches 800,000.

“These patients were less likely to be infected because they were probably less exposed, but once they have the infection, they are more prone to worse outcomes,” lead author Antonio L. Teixeira, MD, PhD, professor of psychiatry with McGovern Medical School at the University of Texas Health Science Center at Houston, said in an interview.

The study was published online Nov. 23 in JAMA Network Open.
 

Unexpected finding

Researchers analyzed electronic health records for 2.5 million adults with private health insurance who were tested for COVID-19 in 2020.

The overall positivity rate for the entire cohort was 11.91%, and patients with severe psychiatric illness fell below that rate. Positivity rates were 9.86% for people with schizophrenia or mood disorders and 11.17% among those with anxiety disorder.

Despite their lower positivity rate, patients with schizophrenia had the highest odds of death from COVID-19 after adjustment for age, race, body mass index, and comorbidities (aOR, 3.74; 95% confidence interval, 2.66-5.24).

Those results were not very surprising, Dr. Teixeira said, as earlier studies have reported similar findings. However, the data on individuals with mood and anxiety disorders were unexpected.

Patients with mood disorders were nearly three times as likely to die (aOR, 2.76; 95% CI, 2.00-3.81), and those with anxiety disorders had more than double the mortality risk (aOR, 2.34; 95% CI, 1.68-3.27).

“We were expecting some increase, but there was strong evidence in those populations as well,” he said. “We were especially surprised at the data on patients with anxiety disorders.”
 

An outstanding question

These findings contradict a study published Jan. 27, 2021, in JAMA Psychiatry, that showed no significant increase in mortality risk among those with mood or anxiety disorders.

Study methodology and timing might explain some of the differences, Katlyn Nemani, MD, a research assistant professor of psychiatry at New York University, who led that earlier study, said in an interview.

Dr. Nemani’s study had a smaller study sample, examined mortality over a 30-day period after a positive COVID-19 test, and was limited to the peak of the pandemic in New York, between March and May 2020. Dr. Teixeira’s team examined a full year of data and assessed mortality for 7 days following a positive test.

“It is possible patients with some psychiatric disorders were less likely to receive or successfully respond to treatment for severe COVD-19 which evolved during the course of the pandemic,” Dr. Nemani said, adding that it’s also possible that differences in mortality in the days following infection became attenuated over time.

While a meta-analysis published in July and reported by this news organization at that time did show higher COVID-19 mortality among patients with mood disorders, the risk was far lower than that reported in this new study. That report, which included 33 studies in 22 countries, also found no increase in risk among those with anxiety disorder.

In October, the Centers for Disease Control and Prevention added mood disorders to the list of medical conditions that increase the risk for more severe COVID-19. Schizophrenia was already on that list.

“The outstanding question is what underlies this increased risk,” Dr. Nemani said. “Future studies focused on immune-mediated mechanisms and other potential explanations will help guide targeted interventions to reduce morbidity and mortality in this vulnerable population.”

Funding for the study was not disclosed. Dr. Teixeira and Dr. Nemani report no conflicts of interest.

A version of this article first appeared on Medscape.com.

Schizophrenia and severe mood and anxiety disorders are associated with a significantly lower risk of COVID-19 but are tied to a two- to fourfold increased risk of death from the virus, new research shows.

The study results held after the researchers controlled for other risk factors, and they contradict an earlier study that showed no increased mortality risk associated with mood or anxiety disorders. The findings come as the overall number of deaths in the United States approaches 800,000.

“These patients were less likely to be infected because they were probably less exposed, but once they have the infection, they are more prone to worse outcomes,” lead author Antonio L. Teixeira, MD, PhD, professor of psychiatry with McGovern Medical School at the University of Texas Health Science Center at Houston, said in an interview.

The study was published online Nov. 23 in JAMA Network Open.
 

Unexpected finding

Researchers analyzed electronic health records for 2.5 million adults with private health insurance who were tested for COVID-19 in 2020.

The overall positivity rate for the entire cohort was 11.91%, and patients with severe psychiatric illness fell below that rate. Positivity rates were 9.86% for people with schizophrenia or mood disorders and 11.17% among those with anxiety disorder.

Despite their lower positivity rate, patients with schizophrenia had the highest odds of death from COVID-19 after adjustment for age, race, body mass index, and comorbidities (aOR, 3.74; 95% confidence interval, 2.66-5.24).

Those results were not very surprising, Dr. Teixeira said, as earlier studies have reported similar findings. However, the data on individuals with mood and anxiety disorders were unexpected.

Patients with mood disorders were nearly three times as likely to die (aOR, 2.76; 95% CI, 2.00-3.81), and those with anxiety disorders had more than double the mortality risk (aOR, 2.34; 95% CI, 1.68-3.27).

“We were expecting some increase, but there was strong evidence in those populations as well,” he said. “We were especially surprised at the data on patients with anxiety disorders.”
 

An outstanding question

These findings contradict a study published Jan. 27, 2021, in JAMA Psychiatry, that showed no significant increase in mortality risk among those with mood or anxiety disorders.

Study methodology and timing might explain some of the differences, Katlyn Nemani, MD, a research assistant professor of psychiatry at New York University, who led that earlier study, said in an interview.

Dr. Nemani’s study had a smaller study sample, examined mortality over a 30-day period after a positive COVID-19 test, and was limited to the peak of the pandemic in New York, between March and May 2020. Dr. Teixeira’s team examined a full year of data and assessed mortality for 7 days following a positive test.

“It is possible patients with some psychiatric disorders were less likely to receive or successfully respond to treatment for severe COVD-19 which evolved during the course of the pandemic,” Dr. Nemani said, adding that it’s also possible that differences in mortality in the days following infection became attenuated over time.

While a meta-analysis published in July and reported by this news organization at that time did show higher COVID-19 mortality among patients with mood disorders, the risk was far lower than that reported in this new study. That report, which included 33 studies in 22 countries, also found no increase in risk among those with anxiety disorder.

In October, the Centers for Disease Control and Prevention added mood disorders to the list of medical conditions that increase the risk for more severe COVID-19. Schizophrenia was already on that list.

“The outstanding question is what underlies this increased risk,” Dr. Nemani said. “Future studies focused on immune-mediated mechanisms and other potential explanations will help guide targeted interventions to reduce morbidity and mortality in this vulnerable population.”

Funding for the study was not disclosed. Dr. Teixeira and Dr. Nemani report no conflicts of interest.

A version of this article first appeared on Medscape.com.

A new blood test that identifies a variant of the protein P53 appears to predict Alzheimer’s disease (AD) progression up to 6 years in advance of a clinical diagnosis, early research suggests.

Analysis of two studies showed the test (AlzoSure Predict), which uses less than 1 ml of blood, had numerous benefits compared with other blood tests that track AD pathology.

“We believe this has the potential to radically improve early stratification and identification of patients for trials 6 years in advance of a diagnosis, which can potentially enable more rapid and efficient approvals of therapies,” Paul Kinnon, CEO of Diadem, the test’s manufacturer, said in an interview.

The findings were presented at the 14th Clinical Trials on Alzheimer’s Disease (CTAD) conference.
 

Positive “discovery” results

P53, which is present in both the brain and elsewhere in the body, “is one of the most targeted proteins” for drug development in cancer and other conditions, said Mr. Kinnon.

The current blood test measures a derivative of P53 (U-p53AZ). Previous research suggests this derivative, which affects amyloid and oxidative stress, is also implicated in AD pathogenesis.

Researchers used blood samples from patients aged 60 years and older from the Australia Imaging, Biomarkers, and Lifestyles (AIBL) study who had various levels of cognitive function.

They analyzed samples at multiple timepoints over a 10-year period, “so we know when the marker is most accurate at predicting decline,” Mr. Kinnon said.

The first of two studies was considered a “discovery” study and included blood samples from 224 patients.

Results showed the test predicted decline from mild cognitive impairment (MCI) to AD at the end of 6 years, with an area under the curve (AUC) greater than 90%.

These results are “massive,” said Mr. Kinnon. “It’s the most accurate test I’ve seen anywhere for predicting decline of a patient.”

The test can also accurately classify a patient’s stage of cognition, he added. “Not only does it allow us to predict 6 years in advance, it also tells us if the patient has SMC [subjective memory complaints], MCI, or AD with a 95% certainty,” Mr. Kinnon said.

He noted that test sensitivity was higher than results found from traditional methods that are currently being used. The positive predictive value (PPV) and negative predictive value (NPV), which were at 90% or more, were “absolutely fantastic,” said Mr. Kinnon.
 

“Better than expected” results

In the second “validation” study, investigators examined samples from a completely different group of 482 patients. The “very compelling” results showed AUCs over 90%, PPVs over 90%, and “very high” NPVs, Mr. Kinnon said.

“These are great data, better than we expected,” he added.

However, he noted the test is “very specific” for decline to AD and not to other dementias.

In addition, Mr. Kinnon noted the test does not monitor levels of amyloid beta or tau, which accumulate at a later stage of AD. “Amyloid and tau tell you you’ve got it. We’re there way before those concentrations become detectable,” he said.

Identifying patients who will progress to AD years before they have symptoms gives them time to make medical decisions. These patients may also try treatments at an earlier stage of the disease, when these therapies are most likely to be helpful, said Mr. Kinnon.

In addition, using the test could speed up the approval of prospective drug treatments for AD. Currently, pharmaceutical companies enroll thousands of patients into a clinical study “and they don’t know which ones will have AD,” Mr. Kinnon noted.

“This test tells you these are the ones who are going to progress and should go into the study, and these are the ones that aren’t. So it makes the studies statistically relevant and accurate,” he said.

Investigators can also use the test to monitor patients during a study instead of relying on expensive PET scans and painful and costly spinal fluid taps, he added.

Previous surveys and market research have shown that neurologists and general practitioners “want a blood test to screen patients early, to help educate and inform patients,” said Mr. Kinnon.

Further results that will include biobank data on more than 1,000 patients in the United States and Europe are due for completion toward the end of this year.

The company is currently in negotiations to bring the product to North America, Europe, and elsewhere. “Our goal is to have it on the market by the middle of next year in multiple regions,” Mr. Kinnon said.
 

Encouraging, preliminary

Commenting on the findings, Percy Griffin, PhD, MSc, director of scientific engagement at the Alzheimer’s Association, said “it’s exciting” to see development of novel ways for detecting or predicting AD.

“There is an urgent need for simple, inexpensive, noninvasive, and accessible early detection tools for Alzheimer’s, such as a blood test,” he said.

However, Dr. Griffin cautioned the test is still in the early stages of development and has not been tested extensively in large, diverse clinical trials.

In addition, although the test predicts whether a person will progress, it does not predict when the person will progress, he added.

“These preliminary results are encouraging, but further validation is needed before this test can be implemented widely,” he said.

Technologies that facilitate the early detection and intervention before significant loss of brain cells from AD “would be game-changing” for individuals, families, and the healthcare system, Dr. Griffin concluded.

A version of this article first appeared on Medscape.com.

A new blood test that identifies a variant of the protein P53 appears to predict Alzheimer’s disease (AD) progression up to 6 years in advance of a clinical diagnosis, early research suggests.

Analysis of two studies showed the test (AlzoSure Predict), which uses less than 1 ml of blood, had numerous benefits compared with other blood tests that track AD pathology.

“We believe this has the potential to radically improve early stratification and identification of patients for trials 6 years in advance of a diagnosis, which can potentially enable more rapid and efficient approvals of therapies,” Paul Kinnon, CEO of Diadem, the test’s manufacturer, said in an interview.

The findings were presented at the 14th Clinical Trials on Alzheimer’s Disease (CTAD) conference.
 

Positive “discovery” results

P53, which is present in both the brain and elsewhere in the body, “is one of the most targeted proteins” for drug development in cancer and other conditions, said Mr. Kinnon.

The current blood test measures a derivative of P53 (U-p53AZ). Previous research suggests this derivative, which affects amyloid and oxidative stress, is also implicated in AD pathogenesis.

Researchers used blood samples from patients aged 60 years and older from the Australia Imaging, Biomarkers, and Lifestyles (AIBL) study who had various levels of cognitive function.

They analyzed samples at multiple timepoints over a 10-year period, “so we know when the marker is most accurate at predicting decline,” Mr. Kinnon said.

The first of two studies was considered a “discovery” study and included blood samples from 224 patients.

Results showed the test predicted decline from mild cognitive impairment (MCI) to AD at the end of 6 years, with an area under the curve (AUC) greater than 90%.

These results are “massive,” said Mr. Kinnon. “It’s the most accurate test I’ve seen anywhere for predicting decline of a patient.”

The test can also accurately classify a patient’s stage of cognition, he added. “Not only does it allow us to predict 6 years in advance, it also tells us if the patient has SMC [subjective memory complaints], MCI, or AD with a 95% certainty,” Mr. Kinnon said.

He noted that test sensitivity was higher than results found from traditional methods that are currently being used. The positive predictive value (PPV) and negative predictive value (NPV), which were at 90% or more, were “absolutely fantastic,” said Mr. Kinnon.
 

“Better than expected” results

In the second “validation” study, investigators examined samples from a completely different group of 482 patients. The “very compelling” results showed AUCs over 90%, PPVs over 90%, and “very high” NPVs, Mr. Kinnon said.

“These are great data, better than we expected,” he added.

However, he noted the test is “very specific” for decline to AD and not to other dementias.

In addition, Mr. Kinnon noted the test does not monitor levels of amyloid beta or tau, which accumulate at a later stage of AD. “Amyloid and tau tell you you’ve got it. We’re there way before those concentrations become detectable,” he said.

Identifying patients who will progress to AD years before they have symptoms gives them time to make medical decisions. These patients may also try treatments at an earlier stage of the disease, when these therapies are most likely to be helpful, said Mr. Kinnon.

In addition, using the test could speed up the approval of prospective drug treatments for AD. Currently, pharmaceutical companies enroll thousands of patients into a clinical study “and they don’t know which ones will have AD,” Mr. Kinnon noted.

“This test tells you these are the ones who are going to progress and should go into the study, and these are the ones that aren’t. So it makes the studies statistically relevant and accurate,” he said.

Investigators can also use the test to monitor patients during a study instead of relying on expensive PET scans and painful and costly spinal fluid taps, he added.

Previous surveys and market research have shown that neurologists and general practitioners “want a blood test to screen patients early, to help educate and inform patients,” said Mr. Kinnon.

Further results that will include biobank data on more than 1,000 patients in the United States and Europe are due for completion toward the end of this year.

The company is currently in negotiations to bring the product to North America, Europe, and elsewhere. “Our goal is to have it on the market by the middle of next year in multiple regions,” Mr. Kinnon said.
 

Encouraging, preliminary

Commenting on the findings, Percy Griffin, PhD, MSc, director of scientific engagement at the Alzheimer’s Association, said “it’s exciting” to see development of novel ways for detecting or predicting AD.

“There is an urgent need for simple, inexpensive, noninvasive, and accessible early detection tools for Alzheimer’s, such as a blood test,” he said.

However, Dr. Griffin cautioned the test is still in the early stages of development and has not been tested extensively in large, diverse clinical trials.

In addition, although the test predicts whether a person will progress, it does not predict when the person will progress, he added.

“These preliminary results are encouraging, but further validation is needed before this test can be implemented widely,” he said.

Technologies that facilitate the early detection and intervention before significant loss of brain cells from AD “would be game-changing” for individuals, families, and the healthcare system, Dr. Griffin concluded.

A version of this article first appeared on Medscape.com.

A new blood test that identifies a variant of the protein P53 appears to predict Alzheimer’s disease (AD) progression up to 6 years in advance of a clinical diagnosis, early research suggests.

Analysis of two studies showed the test (AlzoSure Predict), which uses less than 1 ml of blood, had numerous benefits compared with other blood tests that track AD pathology.

“We believe this has the potential to radically improve early stratification and identification of patients for trials 6 years in advance of a diagnosis, which can potentially enable more rapid and efficient approvals of therapies,” Paul Kinnon, CEO of Diadem, the test’s manufacturer, said in an interview.

The findings were presented at the 14th Clinical Trials on Alzheimer’s Disease (CTAD) conference.
 

Positive “discovery” results

P53, which is present in both the brain and elsewhere in the body, “is one of the most targeted proteins” for drug development in cancer and other conditions, said Mr. Kinnon.

The current blood test measures a derivative of P53 (U-p53AZ). Previous research suggests this derivative, which affects amyloid and oxidative stress, is also implicated in AD pathogenesis.

Researchers used blood samples from patients aged 60 years and older from the Australia Imaging, Biomarkers, and Lifestyles (AIBL) study who had various levels of cognitive function.

They analyzed samples at multiple timepoints over a 10-year period, “so we know when the marker is most accurate at predicting decline,” Mr. Kinnon said.

The first of two studies was considered a “discovery” study and included blood samples from 224 patients.

Results showed the test predicted decline from mild cognitive impairment (MCI) to AD at the end of 6 years, with an area under the curve (AUC) greater than 90%.

These results are “massive,” said Mr. Kinnon. “It’s the most accurate test I’ve seen anywhere for predicting decline of a patient.”

The test can also accurately classify a patient’s stage of cognition, he added. “Not only does it allow us to predict 6 years in advance, it also tells us if the patient has SMC [subjective memory complaints], MCI, or AD with a 95% certainty,” Mr. Kinnon said.

He noted that test sensitivity was higher than results found from traditional methods that are currently being used. The positive predictive value (PPV) and negative predictive value (NPV), which were at 90% or more, were “absolutely fantastic,” said Mr. Kinnon.
 

“Better than expected” results

In the second “validation” study, investigators examined samples from a completely different group of 482 patients. The “very compelling” results showed AUCs over 90%, PPVs over 90%, and “very high” NPVs, Mr. Kinnon said.

“These are great data, better than we expected,” he added.

However, he noted the test is “very specific” for decline to AD and not to other dementias.

In addition, Mr. Kinnon noted the test does not monitor levels of amyloid beta or tau, which accumulate at a later stage of AD. “Amyloid and tau tell you you’ve got it. We’re there way before those concentrations become detectable,” he said.

Identifying patients who will progress to AD years before they have symptoms gives them time to make medical decisions. These patients may also try treatments at an earlier stage of the disease, when these therapies are most likely to be helpful, said Mr. Kinnon.

In addition, using the test could speed up the approval of prospective drug treatments for AD. Currently, pharmaceutical companies enroll thousands of patients into a clinical study “and they don’t know which ones will have AD,” Mr. Kinnon noted.

“This test tells you these are the ones who are going to progress and should go into the study, and these are the ones that aren’t. So it makes the studies statistically relevant and accurate,” he said.

Investigators can also use the test to monitor patients during a study instead of relying on expensive PET scans and painful and costly spinal fluid taps, he added.

Previous surveys and market research have shown that neurologists and general practitioners “want a blood test to screen patients early, to help educate and inform patients,” said Mr. Kinnon.

Further results that will include biobank data on more than 1,000 patients in the United States and Europe are due for completion toward the end of this year.

The company is currently in negotiations to bring the product to North America, Europe, and elsewhere. “Our goal is to have it on the market by the middle of next year in multiple regions,” Mr. Kinnon said.
 

Encouraging, preliminary

Commenting on the findings, Percy Griffin, PhD, MSc, director of scientific engagement at the Alzheimer’s Association, said “it’s exciting” to see development of novel ways for detecting or predicting AD.

“There is an urgent need for simple, inexpensive, noninvasive, and accessible early detection tools for Alzheimer’s, such as a blood test,” he said.

However, Dr. Griffin cautioned the test is still in the early stages of development and has not been tested extensively in large, diverse clinical trials.

In addition, although the test predicts whether a person will progress, it does not predict when the person will progress, he added.

“These preliminary results are encouraging, but further validation is needed before this test can be implemented widely,” he said.

Technologies that facilitate the early detection and intervention before significant loss of brain cells from AD “would be game-changing” for individuals, families, and the healthcare system, Dr. Griffin concluded.

A version of this article first appeared on Medscape.com.

A patient has been sentenced to life in prison 4 years after brutally murdering his psychiatrist.

According to news reports, Umar Dutt, then age 21, went to the office of psychiatrist Achutha Reddy, MD, in Wichita, Kan., on Sept. 19, 2017, aiming to hold the doctor hostage. Dr. Reddy’s office manager reportedly heard noise coming from the closed office and after entering, found Mr. Dutt assaulting the 57-year-old Dr. Reddy.

She intervened, and Dr. Reddy fled the building, but Mr. Dutt followed him and ultimately stabbed the physician more than 160 times. Mr. Dutt than ran over Dr. Reddy’s body.

The patient was arrested that day elsewhere and initially entered a “not guilty” plea in Sedgwick County District Court in 2019. Mr. Dutt was held in the county jail on a $1 million bond.

In September 2021, he changed his plea to guilty. He was sentenced on Nov. 9.

According to news reports, Mr. Dutt will be eligible for parole in 25 years. He received credit for time served of 4 years. The prosecutors and defense attorneys and the judge recommended that Mr. Dutt serve his sentence at Larned Correctional Mental Health Facility because of a history of mental illness.

KWCH reports that the Kansas Department of Corrections will ultimately decide where Mr. Dutt will be incarcerated.

Dr. Reddy left behind a wife and three children.

At Mr. Dutt’s sentencing hearing, Dr. Reddy’s widow, Beena Reddy, MD, a Wichita-based anesthesiologist, reportedly told the court: “My children and I have been devastated by Achutha’s death. Our stability, our security, our peace of mind, has been destroyed by the premeditated, evil actions of Umar Dutt.”

A version of this article first appeared on Medscape.com.

A patient has been sentenced to life in prison 4 years after brutally murdering his psychiatrist.

According to news reports, Umar Dutt, then age 21, went to the office of psychiatrist Achutha Reddy, MD, in Wichita, Kan., on Sept. 19, 2017, aiming to hold the doctor hostage. Dr. Reddy’s office manager reportedly heard noise coming from the closed office and after entering, found Mr. Dutt assaulting the 57-year-old Dr. Reddy.

She intervened, and Dr. Reddy fled the building, but Mr. Dutt followed him and ultimately stabbed the physician more than 160 times. Mr. Dutt than ran over Dr. Reddy’s body.

The patient was arrested that day elsewhere and initially entered a “not guilty” plea in Sedgwick County District Court in 2019. Mr. Dutt was held in the county jail on a $1 million bond.

In September 2021, he changed his plea to guilty. He was sentenced on Nov. 9.

According to news reports, Mr. Dutt will be eligible for parole in 25 years. He received credit for time served of 4 years. The prosecutors and defense attorneys and the judge recommended that Mr. Dutt serve his sentence at Larned Correctional Mental Health Facility because of a history of mental illness.

KWCH reports that the Kansas Department of Corrections will ultimately decide where Mr. Dutt will be incarcerated.

Dr. Reddy left behind a wife and three children.

At Mr. Dutt’s sentencing hearing, Dr. Reddy’s widow, Beena Reddy, MD, a Wichita-based anesthesiologist, reportedly told the court: “My children and I have been devastated by Achutha’s death. Our stability, our security, our peace of mind, has been destroyed by the premeditated, evil actions of Umar Dutt.”

A version of this article first appeared on Medscape.com.

A patient has been sentenced to life in prison 4 years after brutally murdering his psychiatrist.

According to news reports, Umar Dutt, then age 21, went to the office of psychiatrist Achutha Reddy, MD, in Wichita, Kan., on Sept. 19, 2017, aiming to hold the doctor hostage. Dr. Reddy’s office manager reportedly heard noise coming from the closed office and after entering, found Mr. Dutt assaulting the 57-year-old Dr. Reddy.

She intervened, and Dr. Reddy fled the building, but Mr. Dutt followed him and ultimately stabbed the physician more than 160 times. Mr. Dutt than ran over Dr. Reddy’s body.

The patient was arrested that day elsewhere and initially entered a “not guilty” plea in Sedgwick County District Court in 2019. Mr. Dutt was held in the county jail on a $1 million bond.

In September 2021, he changed his plea to guilty. He was sentenced on Nov. 9.

According to news reports, Mr. Dutt will be eligible for parole in 25 years. He received credit for time served of 4 years. The prosecutors and defense attorneys and the judge recommended that Mr. Dutt serve his sentence at Larned Correctional Mental Health Facility because of a history of mental illness.

KWCH reports that the Kansas Department of Corrections will ultimately decide where Mr. Dutt will be incarcerated.

Dr. Reddy left behind a wife and three children.

At Mr. Dutt’s sentencing hearing, Dr. Reddy’s widow, Beena Reddy, MD, a Wichita-based anesthesiologist, reportedly told the court: “My children and I have been devastated by Achutha’s death. Our stability, our security, our peace of mind, has been destroyed by the premeditated, evil actions of Umar Dutt.”

A version of this article first appeared on Medscape.com.

A newly released position statement from the American Academy of Neurology (AAN) provides guidance to neurologists about counseling  patients with Alzheimer’s disease and their families about the controversial drug aducanumab (Aduhelm).

The statement includes ethical considerations and recommendations for informed consent, and the AAN notes that neurologists should ensure that patients understand all of the issues and uncertainties surrounding the use of aducanumab.

“Neurologists and other clinicians want to provide the best care to patients and families, particularly for a disease that is as challenging as Alzheimer’s. We hope that this statement can be a guide for clinicians in communicating with patients and families in order to carefully consider decisions about the use of aducanumab,” said lead author Winston Chiong, MD, PhD, University of California San Francisco Memory and Aging Center, and a member of the AAN’s Ethics, Law, and Humanities Committee.

The statement was published online Nov. 17 in Neurology.
 

Open, honest communication

The Food and Drug Administration approved the antiamyloid agent aducanumab based on two studies that were both stopped prematurely for futility. In subsequent post hoc analyses of the available data, one of those studies indicated a statistically significant, albeit small, benefit with high-dose aducanumab, while the other study continued to show no benefit.

The clinical importance of the small statistical benefit in the single trial for daily function is unclear, and aducanumab was also associated with brain inflammation and brain bleeds in more than one-third of patients who received the FDA-approved dose, which requires regular brain MRI monitoring.

All of this should be communicated to patients, the AAN advises.

Patients should know that while aducanumab reduces beta-amyloid plaques in the brain that are markers of Alzheimer’s disease, it remains unclear whether this provides any meaningful benefit.

The AAN adds that it is equally important to tell patients and families that aducanumab does not restore cognitive function and that there is insufficient data to offer it to people with moderate or advanced dementia or to those without evidence of beta-amyloid plaques.

It’s important to note that very few participants in the aducanumab trials were Hispanic, Black, or Indigenous. 

“Informed consent conversations with patients of populations underrepresented in clinical trials should include disclosure about the absence of safety and efficacy data in these groups,” the authors noted.
 

‘New territory’ for neurologists

“There are two aspects of aducanumab that are relatively new territory for us as neurologists,” Dr. Chiong said. One is the controversy about the evidence for the drug. “In the statement, we’ve tried to help clinicians communicate the uncertainty over aducanumab’s risks and potential benefits,” Dr. Chiong said. The other is the high cost of the drug and how it will be covered.

Aducanumab has a price tag of $56,000 per year, which does not include the cost of infusing the drug, required repeat imaging, and medical management.

The AAN estimates annual costs of prescribing aducanumab may top $100,000 per year. With Medicare generally covering 80%, patients and families must be told that the full costs of treatment may not be covered.

“Regarding cost, we probably don’t think often enough about what prescribing a drug means for an individual patient’s finances and for the health system,” said Dr. Chiong. “In particular, when patients are in Medicare we might assume their health care costs will be sufficiently covered, but because aducanumab is so expensive its use is likely to impose very significant costs on individual patients as well as to the Medicare program,” Dr. Chiong said.

“It is understandable why a new drug for Alzheimer’s disease generates so much interest, because while its approval has been controversial, it still offers a glimmer of hope to patients and their families,” AAN President Orly Avitzur, MD, said in a news release. “By using ethical principles to create this position statement, the American Academy of Neurology aims to help neurologists and other physicians transparently counsel patients and their families with a goal of providing the highest quality patient-centered care,” Dr. Avitzur said.

This statement was approved by the Ethics, Law, and Humanities Committee, a joint committee of the AAN, American Neurological Association, and Child Neurology Society.

This research had no targeted funding. Dr. Chiong has received personal compensation for serving on the Neuroethics Working Group of the National Institutes of Health BRAIN Initiative, and his institution has received research support from the National Institutes of Health. A complete list of author disclosures is available with the original article.

A version of this article first appeared on Medscape.com.

A newly released position statement from the American Academy of Neurology (AAN) provides guidance to neurologists about counseling  patients with Alzheimer’s disease and their families about the controversial drug aducanumab (Aduhelm).

The statement includes ethical considerations and recommendations for informed consent, and the AAN notes that neurologists should ensure that patients understand all of the issues and uncertainties surrounding the use of aducanumab.

“Neurologists and other clinicians want to provide the best care to patients and families, particularly for a disease that is as challenging as Alzheimer’s. We hope that this statement can be a guide for clinicians in communicating with patients and families in order to carefully consider decisions about the use of aducanumab,” said lead author Winston Chiong, MD, PhD, University of California San Francisco Memory and Aging Center, and a member of the AAN’s Ethics, Law, and Humanities Committee.

The statement was published online Nov. 17 in Neurology.
 

Open, honest communication

The Food and Drug Administration approved the antiamyloid agent aducanumab based on two studies that were both stopped prematurely for futility. In subsequent post hoc analyses of the available data, one of those studies indicated a statistically significant, albeit small, benefit with high-dose aducanumab, while the other study continued to show no benefit.

The clinical importance of the small statistical benefit in the single trial for daily function is unclear, and aducanumab was also associated with brain inflammation and brain bleeds in more than one-third of patients who received the FDA-approved dose, which requires regular brain MRI monitoring.

All of this should be communicated to patients, the AAN advises.

Patients should know that while aducanumab reduces beta-amyloid plaques in the brain that are markers of Alzheimer’s disease, it remains unclear whether this provides any meaningful benefit.

The AAN adds that it is equally important to tell patients and families that aducanumab does not restore cognitive function and that there is insufficient data to offer it to people with moderate or advanced dementia or to those without evidence of beta-amyloid plaques.

It’s important to note that very few participants in the aducanumab trials were Hispanic, Black, or Indigenous. 

“Informed consent conversations with patients of populations underrepresented in clinical trials should include disclosure about the absence of safety and efficacy data in these groups,” the authors noted.
 

‘New territory’ for neurologists

“There are two aspects of aducanumab that are relatively new territory for us as neurologists,” Dr. Chiong said. One is the controversy about the evidence for the drug. “In the statement, we’ve tried to help clinicians communicate the uncertainty over aducanumab’s risks and potential benefits,” Dr. Chiong said. The other is the high cost of the drug and how it will be covered.

Aducanumab has a price tag of $56,000 per year, which does not include the cost of infusing the drug, required repeat imaging, and medical management.

The AAN estimates annual costs of prescribing aducanumab may top $100,000 per year. With Medicare generally covering 80%, patients and families must be told that the full costs of treatment may not be covered.

“Regarding cost, we probably don’t think often enough about what prescribing a drug means for an individual patient’s finances and for the health system,” said Dr. Chiong. “In particular, when patients are in Medicare we might assume their health care costs will be sufficiently covered, but because aducanumab is so expensive its use is likely to impose very significant costs on individual patients as well as to the Medicare program,” Dr. Chiong said.

“It is understandable why a new drug for Alzheimer’s disease generates so much interest, because while its approval has been controversial, it still offers a glimmer of hope to patients and their families,” AAN President Orly Avitzur, MD, said in a news release. “By using ethical principles to create this position statement, the American Academy of Neurology aims to help neurologists and other physicians transparently counsel patients and their families with a goal of providing the highest quality patient-centered care,” Dr. Avitzur said.

This statement was approved by the Ethics, Law, and Humanities Committee, a joint committee of the AAN, American Neurological Association, and Child Neurology Society.

This research had no targeted funding. Dr. Chiong has received personal compensation for serving on the Neuroethics Working Group of the National Institutes of Health BRAIN Initiative, and his institution has received research support from the National Institutes of Health. A complete list of author disclosures is available with the original article.

A version of this article first appeared on Medscape.com.

A newly released position statement from the American Academy of Neurology (AAN) provides guidance to neurologists about counseling  patients with Alzheimer’s disease and their families about the controversial drug aducanumab (Aduhelm).

The statement includes ethical considerations and recommendations for informed consent, and the AAN notes that neurologists should ensure that patients understand all of the issues and uncertainties surrounding the use of aducanumab.

“Neurologists and other clinicians want to provide the best care to patients and families, particularly for a disease that is as challenging as Alzheimer’s. We hope that this statement can be a guide for clinicians in communicating with patients and families in order to carefully consider decisions about the use of aducanumab,” said lead author Winston Chiong, MD, PhD, University of California San Francisco Memory and Aging Center, and a member of the AAN’s Ethics, Law, and Humanities Committee.

The statement was published online Nov. 17 in Neurology.
 

Open, honest communication

The Food and Drug Administration approved the antiamyloid agent aducanumab based on two studies that were both stopped prematurely for futility. In subsequent post hoc analyses of the available data, one of those studies indicated a statistically significant, albeit small, benefit with high-dose aducanumab, while the other study continued to show no benefit.

The clinical importance of the small statistical benefit in the single trial for daily function is unclear, and aducanumab was also associated with brain inflammation and brain bleeds in more than one-third of patients who received the FDA-approved dose, which requires regular brain MRI monitoring.

All of this should be communicated to patients, the AAN advises.

Patients should know that while aducanumab reduces beta-amyloid plaques in the brain that are markers of Alzheimer’s disease, it remains unclear whether this provides any meaningful benefit.

The AAN adds that it is equally important to tell patients and families that aducanumab does not restore cognitive function and that there is insufficient data to offer it to people with moderate or advanced dementia or to those without evidence of beta-amyloid plaques.

It’s important to note that very few participants in the aducanumab trials were Hispanic, Black, or Indigenous. 

“Informed consent conversations with patients of populations underrepresented in clinical trials should include disclosure about the absence of safety and efficacy data in these groups,” the authors noted.
 

‘New territory’ for neurologists

“There are two aspects of aducanumab that are relatively new territory for us as neurologists,” Dr. Chiong said. One is the controversy about the evidence for the drug. “In the statement, we’ve tried to help clinicians communicate the uncertainty over aducanumab’s risks and potential benefits,” Dr. Chiong said. The other is the high cost of the drug and how it will be covered.

Aducanumab has a price tag of $56,000 per year, which does not include the cost of infusing the drug, required repeat imaging, and medical management.

The AAN estimates annual costs of prescribing aducanumab may top $100,000 per year. With Medicare generally covering 80%, patients and families must be told that the full costs of treatment may not be covered.

“Regarding cost, we probably don’t think often enough about what prescribing a drug means for an individual patient’s finances and for the health system,” said Dr. Chiong. “In particular, when patients are in Medicare we might assume their health care costs will be sufficiently covered, but because aducanumab is so expensive its use is likely to impose very significant costs on individual patients as well as to the Medicare program,” Dr. Chiong said.

“It is understandable why a new drug for Alzheimer’s disease generates so much interest, because while its approval has been controversial, it still offers a glimmer of hope to patients and their families,” AAN President Orly Avitzur, MD, said in a news release. “By using ethical principles to create this position statement, the American Academy of Neurology aims to help neurologists and other physicians transparently counsel patients and their families with a goal of providing the highest quality patient-centered care,” Dr. Avitzur said.

This statement was approved by the Ethics, Law, and Humanities Committee, a joint committee of the AAN, American Neurological Association, and Child Neurology Society.

This research had no targeted funding. Dr. Chiong has received personal compensation for serving on the Neuroethics Working Group of the National Institutes of Health BRAIN Initiative, and his institution has received research support from the National Institutes of Health. A complete list of author disclosures is available with the original article.

A version of this article first appeared on Medscape.com.

Short-acting opioids may complement methadone and buprenorphine for opioid withdrawal symptoms in U.S. hospitals, say authors of an opinion piece calling for rethinking current strategies for opioid withdrawal in this country.

The commentary by Robert A. Kleinman, MD, with the Centre for Addiction and Mental Health, and department of psychiatry, University of Toronto, and Sarah E. Wakeman, MD, with the division of general internal medicine at Massachusetts General Hospital, and Harvard Medical School, Boston, was published in Annals of Internal Medicine.

Currently, short-acting opioids are not recommended in the United States for opioid withdrawal symptoms (OWS) management in the hospital, the authors wrote. Instead, withdrawal symptoms are typically treated, followed by methadone or buprenorphine or nonopioid medications, but many patients don’t get enough relief. Undertreated withdrawal can result in patients leaving the hospital against medical advice, which is linked with higher risk of death.

Addiction specialist Elisabeth Poorman, MD, of the University of Illinois Chicago, said in an interview that she agrees it’s time to start shifting the thinking on using short-acting opioids for OWS in hospitals. Use varies greatly by hospital and by clinician, she said.

“It’s time to let evidence guide us and to be flexible,” Dr. Poorman said.

The commentary authors noted that with methadone, patients must wait several hours for maximal symptom reduction, and the full benefits of methadone treatment are not realized until days after initiation.

Rapid initiation of methadone may be feasible in hospitals and has been proposed as an option, but further study is necessary before widespread use, the authors wrote.
 

Short-acting opioids may address limitations of other opioids

Lofexidine, an alpha-2-adrenergic agonist, is the only drug approved by the Food and Drug Administration specifically for OWS.

“However,” the authors said, “more than half of patients with OWS treated with lofexidine in phase 3 efficacy trials dropped out by day five. Clonidine, another alpha-2-agonist used off label to treat OWS, has similar effects to those of lofexidine. “

Therefore, short-acting opioids may complement methadone and buprenorphine in treating OWS in the hospital by addressing their limitations, the authors wrote.

Dr. Kleinman and Dr. Wakeman also say short-acting opioids may help with starting buprenorphine for patients exposed to fentanyl, because short-acting opioids can relieve withdrawal symptoms while fentanyl is metabolized and excreted.

Supplementation with short-acting opioids within the hospital can relieve withdrawal symptoms and help keep patients comfortable while methadone is titrated to more effective doses for long-term treatment, they wrote.

With short-acting opioids, patients may become more engaged in their care with, for example, a tamper-proof, patient-controlled analgesia pump, which would allow them to have more autonomy in administration of opioids to relieve pain and withdrawal symptoms, the authors wrote.

Dr. Kleinman and Dr. Wakeman noted that many patients who inject drugs already consume short-acting illicit drugs in the hospital, typically in washrooms and smoking areas, so supervised use of short-acting opioids helps eliminate the risk for unwitnessed overdoses.

Barriers to short-acting opioid use

Despite use of short-acting opioids internationally, barriers in the United States include limited prospective, randomized, controlled research on their benefits. There is limited institutional support for such approaches, and concerns and stigma around providing opioids to patients with OUD.

“[M]any institutions have insufficient numbers of providers who are both confident and competent with standard buprenorphine and methadone initiation approaches, a prerequisite before adopting more complex regimens,” the authors wrote.

Short-acting, full-agonist opioids, as a complement to methadone or buprenorphine, is already recommended for inpatients with OUD who are experiencing acute pain.

But the authors argue it should be an option when pain is not present, but methadone or buprenorphine have not provided enough OWS relief.
 

When short-acting opioids are helpful, according to outside expert

Dr. Poorman agrees and says she has found short-acting opioids simple to use in the hospital and very helpful in two situations.

One is when patients are very clear that they don’t want any medication for opioid use disorder, but they do want to be treated for their acute medical issue.

“I thought that was a fantastic tool to have to demonstrate we’re listening to them and weren’t trying to impose something on them and left the door open to come back when they did want treatment, which many of them did,” Dr. Poorman said.

The second situation is when the patient is uncertain about options but very afraid of precipitated withdrawal from buprenorphine.

She said she then found it easy to switch from those medications to buprenorphine and methadone.

Dr. Poorman described a situation she encountered previously where the patient was injecting heroin several times a day for 30-40 years. He was very clear he wasn’t going to stop injecting heroin, but he needed medical attention. He was willing to get medical attention, but he told his doctor he didn’t want to be uncomfortable while in the hospital.

It was very hard for his doctor to accept relieving his symptoms of withdrawal as part of her job, because she felt as though she was condoning his drug use, Dr. Poorman explained.

But Dr. Poorman said it’s not realistic to think that someone who clearly does not want to stop using is going to stop using because a doctor made that person go through painful withdrawal “that they’ve structured their whole life around avoiding.”
 

Take-home message

“We need to understand that addiction is very complex. A lot of times people come to us distressed, and it’s a great time to engage them in care but engaging them in care doesn’t mean imposing discomfort or pain on them,” Dr. Poorman noted. Instead, it means “listening to them, helping them be comfortable in a really stressful situation and then letting them know we are always there for them wherever they are on their disease process or recovery journey so that they can come back to us.”

Dr. Wakeman previously served on clinical advisory board for Celero Systems and receives textbook royalties from Springer and author payment from UpToDate. Dr. Kleinman and Dr. Poorman declared no relevant financial relationships.

Short-acting opioids may complement methadone and buprenorphine for opioid withdrawal symptoms in U.S. hospitals, say authors of an opinion piece calling for rethinking current strategies for opioid withdrawal in this country.

The commentary by Robert A. Kleinman, MD, with the Centre for Addiction and Mental Health, and department of psychiatry, University of Toronto, and Sarah E. Wakeman, MD, with the division of general internal medicine at Massachusetts General Hospital, and Harvard Medical School, Boston, was published in Annals of Internal Medicine.

Currently, short-acting opioids are not recommended in the United States for opioid withdrawal symptoms (OWS) management in the hospital, the authors wrote. Instead, withdrawal symptoms are typically treated, followed by methadone or buprenorphine or nonopioid medications, but many patients don’t get enough relief. Undertreated withdrawal can result in patients leaving the hospital against medical advice, which is linked with higher risk of death.

Addiction specialist Elisabeth Poorman, MD, of the University of Illinois Chicago, said in an interview that she agrees it’s time to start shifting the thinking on using short-acting opioids for OWS in hospitals. Use varies greatly by hospital and by clinician, she said.

“It’s time to let evidence guide us and to be flexible,” Dr. Poorman said.

The commentary authors noted that with methadone, patients must wait several hours for maximal symptom reduction, and the full benefits of methadone treatment are not realized until days after initiation.

Rapid initiation of methadone may be feasible in hospitals and has been proposed as an option, but further study is necessary before widespread use, the authors wrote.
 

Short-acting opioids may address limitations of other opioids

Lofexidine, an alpha-2-adrenergic agonist, is the only drug approved by the Food and Drug Administration specifically for OWS.

“However,” the authors said, “more than half of patients with OWS treated with lofexidine in phase 3 efficacy trials dropped out by day five. Clonidine, another alpha-2-agonist used off label to treat OWS, has similar effects to those of lofexidine. “

Therefore, short-acting opioids may complement methadone and buprenorphine in treating OWS in the hospital by addressing their limitations, the authors wrote.

Dr. Kleinman and Dr. Wakeman also say short-acting opioids may help with starting buprenorphine for patients exposed to fentanyl, because short-acting opioids can relieve withdrawal symptoms while fentanyl is metabolized and excreted.

Supplementation with short-acting opioids within the hospital can relieve withdrawal symptoms and help keep patients comfortable while methadone is titrated to more effective doses for long-term treatment, they wrote.

With short-acting opioids, patients may become more engaged in their care with, for example, a tamper-proof, patient-controlled analgesia pump, which would allow them to have more autonomy in administration of opioids to relieve pain and withdrawal symptoms, the authors wrote.

Dr. Kleinman and Dr. Wakeman noted that many patients who inject drugs already consume short-acting illicit drugs in the hospital, typically in washrooms and smoking areas, so supervised use of short-acting opioids helps eliminate the risk for unwitnessed overdoses.

Barriers to short-acting opioid use

Despite use of short-acting opioids internationally, barriers in the United States include limited prospective, randomized, controlled research on their benefits. There is limited institutional support for such approaches, and concerns and stigma around providing opioids to patients with OUD.

“[M]any institutions have insufficient numbers of providers who are both confident and competent with standard buprenorphine and methadone initiation approaches, a prerequisite before adopting more complex regimens,” the authors wrote.

Short-acting, full-agonist opioids, as a complement to methadone or buprenorphine, is already recommended for inpatients with OUD who are experiencing acute pain.

But the authors argue it should be an option when pain is not present, but methadone or buprenorphine have not provided enough OWS relief.
 

When short-acting opioids are helpful, according to outside expert

Dr. Poorman agrees and says she has found short-acting opioids simple to use in the hospital and very helpful in two situations.

One is when patients are very clear that they don’t want any medication for opioid use disorder, but they do want to be treated for their acute medical issue.

“I thought that was a fantastic tool to have to demonstrate we’re listening to them and weren’t trying to impose something on them and left the door open to come back when they did want treatment, which many of them did,” Dr. Poorman said.

The second situation is when the patient is uncertain about options but very afraid of precipitated withdrawal from buprenorphine.

She said she then found it easy to switch from those medications to buprenorphine and methadone.

Dr. Poorman described a situation she encountered previously where the patient was injecting heroin several times a day for 30-40 years. He was very clear he wasn’t going to stop injecting heroin, but he needed medical attention. He was willing to get medical attention, but he told his doctor he didn’t want to be uncomfortable while in the hospital.

It was very hard for his doctor to accept relieving his symptoms of withdrawal as part of her job, because she felt as though she was condoning his drug use, Dr. Poorman explained.

But Dr. Poorman said it’s not realistic to think that someone who clearly does not want to stop using is going to stop using because a doctor made that person go through painful withdrawal “that they’ve structured their whole life around avoiding.”
 

Take-home message

“We need to understand that addiction is very complex. A lot of times people come to us distressed, and it’s a great time to engage them in care but engaging them in care doesn’t mean imposing discomfort or pain on them,” Dr. Poorman noted. Instead, it means “listening to them, helping them be comfortable in a really stressful situation and then letting them know we are always there for them wherever they are on their disease process or recovery journey so that they can come back to us.”

Dr. Wakeman previously served on clinical advisory board for Celero Systems and receives textbook royalties from Springer and author payment from UpToDate. Dr. Kleinman and Dr. Poorman declared no relevant financial relationships.

Short-acting opioids may complement methadone and buprenorphine for opioid withdrawal symptoms in U.S. hospitals, say authors of an opinion piece calling for rethinking current strategies for opioid withdrawal in this country.

The commentary by Robert A. Kleinman, MD, with the Centre for Addiction and Mental Health, and department of psychiatry, University of Toronto, and Sarah E. Wakeman, MD, with the division of general internal medicine at Massachusetts General Hospital, and Harvard Medical School, Boston, was published in Annals of Internal Medicine.

Currently, short-acting opioids are not recommended in the United States for opioid withdrawal symptoms (OWS) management in the hospital, the authors wrote. Instead, withdrawal symptoms are typically treated, followed by methadone or buprenorphine or nonopioid medications, but many patients don’t get enough relief. Undertreated withdrawal can result in patients leaving the hospital against medical advice, which is linked with higher risk of death.

Addiction specialist Elisabeth Poorman, MD, of the University of Illinois Chicago, said in an interview that she agrees it’s time to start shifting the thinking on using short-acting opioids for OWS in hospitals. Use varies greatly by hospital and by clinician, she said.

“It’s time to let evidence guide us and to be flexible,” Dr. Poorman said.

The commentary authors noted that with methadone, patients must wait several hours for maximal symptom reduction, and the full benefits of methadone treatment are not realized until days after initiation.

Rapid initiation of methadone may be feasible in hospitals and has been proposed as an option, but further study is necessary before widespread use, the authors wrote.
 

Short-acting opioids may address limitations of other opioids

Lofexidine, an alpha-2-adrenergic agonist, is the only drug approved by the Food and Drug Administration specifically for OWS.

“However,” the authors said, “more than half of patients with OWS treated with lofexidine in phase 3 efficacy trials dropped out by day five. Clonidine, another alpha-2-agonist used off label to treat OWS, has similar effects to those of lofexidine. “

Therefore, short-acting opioids may complement methadone and buprenorphine in treating OWS in the hospital by addressing their limitations, the authors wrote.

Dr. Kleinman and Dr. Wakeman also say short-acting opioids may help with starting buprenorphine for patients exposed to fentanyl, because short-acting opioids can relieve withdrawal symptoms while fentanyl is metabolized and excreted.

Supplementation with short-acting opioids within the hospital can relieve withdrawal symptoms and help keep patients comfortable while methadone is titrated to more effective doses for long-term treatment, they wrote.

With short-acting opioids, patients may become more engaged in their care with, for example, a tamper-proof, patient-controlled analgesia pump, which would allow them to have more autonomy in administration of opioids to relieve pain and withdrawal symptoms, the authors wrote.

Dr. Kleinman and Dr. Wakeman noted that many patients who inject drugs already consume short-acting illicit drugs in the hospital, typically in washrooms and smoking areas, so supervised use of short-acting opioids helps eliminate the risk for unwitnessed overdoses.

Barriers to short-acting opioid use

Despite use of short-acting opioids internationally, barriers in the United States include limited prospective, randomized, controlled research on their benefits. There is limited institutional support for such approaches, and concerns and stigma around providing opioids to patients with OUD.

“[M]any institutions have insufficient numbers of providers who are both confident and competent with standard buprenorphine and methadone initiation approaches, a prerequisite before adopting more complex regimens,” the authors wrote.

Short-acting, full-agonist opioids, as a complement to methadone or buprenorphine, is already recommended for inpatients with OUD who are experiencing acute pain.

But the authors argue it should be an option when pain is not present, but methadone or buprenorphine have not provided enough OWS relief.
 

When short-acting opioids are helpful, according to outside expert

Dr. Poorman agrees and says she has found short-acting opioids simple to use in the hospital and very helpful in two situations.

One is when patients are very clear that they don’t want any medication for opioid use disorder, but they do want to be treated for their acute medical issue.

“I thought that was a fantastic tool to have to demonstrate we’re listening to them and weren’t trying to impose something on them and left the door open to come back when they did want treatment, which many of them did,” Dr. Poorman said.

The second situation is when the patient is uncertain about options but very afraid of precipitated withdrawal from buprenorphine.

She said she then found it easy to switch from those medications to buprenorphine and methadone.

Dr. Poorman described a situation she encountered previously where the patient was injecting heroin several times a day for 30-40 years. He was very clear he wasn’t going to stop injecting heroin, but he needed medical attention. He was willing to get medical attention, but he told his doctor he didn’t want to be uncomfortable while in the hospital.

It was very hard for his doctor to accept relieving his symptoms of withdrawal as part of her job, because she felt as though she was condoning his drug use, Dr. Poorman explained.

But Dr. Poorman said it’s not realistic to think that someone who clearly does not want to stop using is going to stop using because a doctor made that person go through painful withdrawal “that they’ve structured their whole life around avoiding.”
 

Take-home message

“We need to understand that addiction is very complex. A lot of times people come to us distressed, and it’s a great time to engage them in care but engaging them in care doesn’t mean imposing discomfort or pain on them,” Dr. Poorman noted. Instead, it means “listening to them, helping them be comfortable in a really stressful situation and then letting them know we are always there for them wherever they are on their disease process or recovery journey so that they can come back to us.”

Dr. Wakeman previously served on clinical advisory board for Celero Systems and receives textbook royalties from Springer and author payment from UpToDate. Dr. Kleinman and Dr. Poorman declared no relevant financial relationships.

The negative emotions stemming from teens’ involvement with social media have been grabbing the headlines. But adults may also be experiencing depression because of their use of social media, suggests a new study.

Use of social media has been linked to increased anxiety and depression, as well as reduced well-being in adolescents and young adults, but similar associations in older adults have not been well studied, and longitudinal data are lacking, Ron H. Perlis, MD, of Massachusetts General Hospital, Boston, and colleagues wrote in their paper, which was published in JAMA Network Open.

To examine the association between social media use and depressive symptoms in older adults, the researchers reviewed data from 13 waves of an internet survey conducted each month between May 2020 and May 2021. The survey respondents included individuals aged 18 years and older, with a mean age of 56 years.

In the study the researchers analyzed responses from 5,395 individuals aged 18 years and older, with a mean age of 56 years. The study participants had minimal or no depressive symptoms at baseline, according to scores on the nine-item Patient Health Questionnaire (PHQ-9).

Overall, 8.9% of the respondents reported a worsening of 5 points or more on the PHQ-9 score on a follow-up survey, which was the primary outcome. Participants who reported using social media platforms Snapchat, Facebook, or TikTok were significantly more likely to report increased depressive symptoms, compared with those who did not report use of social media. The fully adjusted odds ratio was largest for Snapchat (aOR, 1.53), followed by Facebook (aOR, 1.42), and TikTok (aOR, 1.39).

Incorporating recent television and internet news terms, such as COVID-19, changed the association for Snapchat, for which the aOR decreased from 1.53 to 1.12 when news source terms were included in the survey. TikTok and Facebook associations remained similar.

When the results were further stratified by age, use of TikTok and Snapchat was associated with depressive symptoms in those aged 35 years and older, but not in those younger than 35 years. However, the opposite pattern emerged for Facebook; use was associated with depressive symptoms for individuals younger than 35 years, but not in those aged 35 years and older (aOR, 2.60 vs. aOR, 1.12).

The association between increased self-reported depressive symptoms and use of certain social media platforms was not impacted by baseline social support or face-to-face interactions, the researchers noted.
 

Family physician was surprised results weren’t more significant

In the current study, “I was honestly surprised the results weren’t more significant,” Mary Ann Dakkak, MD, of Boston University said in an interview. “That said, social media uses during the COVID pandemic may have been a necessary social outlet and form of connection for many people who were otherwise isolated.”

To still see a significant increase in depression when social media could have been a positive force may suggest a heavier impact during “normal” times, she added.

“It is not surprising that what we see in youth is shown among adults,” noted Dr. Dakkak, who was not involved with this study. “I always tell my patients that what is good for their children is good for the adults too, and vice versa.

“We expect to see outcomes of this on youth and adults who have been more isolated, who have used more screen time for learning, work, connection and boredom, in the near future,” she said. “The complex nature of why social media may have been used more heavily for connection during a time when in-person meetings were not possible may be a heavy confounder as the typical profile of heavy social media users may have differed during the COVID shutdowns.”
 

Psychiatrist: Balance benefits of social media with mental health risks

The current study was likely conducted before the recent news on “hidden” Facebook data and the implications that Facebook knew it was contributing to worsened mental health in teens, particularly around self-esteem, Jessica “Jessi” Gold, MD, a psychiatrist at Washington University, St. Louis, said in an interview.

“If you look more specifically at other studies, however, the data around social media and mental health is constantly varied, with some showing benefits and some showing negatives, and none conclusively suggesting either way,” said Dr. Gold, who also was not involved with the new research. “More data are needed, especially longitudinally and on a broader age group, to understand social media’s impact on mental health over time.

“It is also even more important in the wake of COVID-19, as so many people have turned to social media as a primary source of social support and connection, and are using it even more than before,” she emphasized.

In the current study, “I think the most interesting information is that, for TikTok and Snapchat, the effects seemed to be more pronounced in those older than 35 years who used social media,” said Dr. Gold.

What this study leaves unanswered is “whether people who might develop depression are simply more prone to use social media in the first place, such as to seek out social support,” Dr. Gold said. “Also, we don’t know anything about how long they are using social media or what they are using it for, which to me is important for understanding more about the nuance of the relationship with mental health and social media.”
 

Experts advise clinicians to discuss social media with patients

This new research suggests that clinicians should be talking to their patients about how social media impacts their emotional reactions, as well as their sleep, Dr. Gold said.

“Patients should be asking themselves how they are feeling when they are on social media and not using it before sleep. They should also be considering time limits and how to effectively use social media while taking care of their mental health,” she said. This conversation between clinician and patient should be had with any patient of any age, who uses social media, not only with teenagers.

“This is also a conversation about moderation, and knowing that individuals may feel they benefit from social media, that they should balance these benefits with potential mental health risks,” she said.

“Studies such as this one shed light onto why social media consumption should be at least a point of discussion with our patients,” said Dr. Dakkak.

She advised clinicians to ask and listen to patients and their families when it comes to screen time habits. “Whenever I see a patient with mood symptoms, I ask about their habits – eating, sleeping, socializing, screen time – including phone time. I ask about the family dynamics around screen time.

“I’ve added screen time to my adolescent assessment. Discussing safe use of cell phones and social media can have a significant impact on adolescent behavior and wellbeing, and parents are very thankful for the help,” she said. “This study encourages us to add screen time to the assessments we do at all adult ages, especially if mood symptoms exist,” Dr. Dakkak emphasized.
 

Suggestions for future research

Dr. Dakkak added that more areas for research include the differences in the impact of social media use on content creators versus content consumers. Also, “I would like to see research using the real data of use, the times of use, interruptions in sleep and use, possible confounding variables to include exercise, presence of intimate relationship and school/job performance.”

Given the many confounding variables, more controlled studies are needed to examine mental health outcomes in use, how long people use social media, and the impact of interventions such as time limits, Dr. Gold said.

“We can’t ignore the benefits of social media, such as helping those with social anxiety, finding peer support, and normalizing mental health, and those factors need to be studied and measured more effectively as well, she said.
 

Take-home message

It is important to recognize that the current study represents a correlation, not causality, said Dr. Gold. In addressing the issues of how social media impact mental health, “as always, the hardest thing is that many people get their news from social media, and often get social support from social media, so there has to be a balance of not removing social media completely, but of helping people see how it affects their mental health and how to find balance.”

The study findings were limited by several factors, including the inability to control for all potential confounders, the inability to assess the nature of social media use, and the lack of dose-response data, the researchers noted. Although the surveys in the current study were not specific to COVID-19, the effects of social media on depression may be specific to the content, and the findings may not generalize beyond the COVID-19 pandemic period.

Approximately two-thirds (66%) of the study participants identified as female, and 76% as White; 11% as Black; 6% as Asian; 5% as Hispanic; and 2% as American Indian or Alaska Native, Pacific Islander or Native Hawaiian, or other.

The National Institute of Mental Health provided a grant for the study to Dr. Pelis, who disclosed consulting fees from various companies and equity in Psy Therapeutics. The study’s lead author also serves as associate editor for JAMA Network Open, but was not involved in the decision process for publication of this study. Dr. Gold disclosed conducting a conference for Johnson & Johnson about social media and health care workers, and was on the advisory council.

The negative emotions stemming from teens’ involvement with social media have been grabbing the headlines. But adults may also be experiencing depression because of their use of social media, suggests a new study.

Use of social media has been linked to increased anxiety and depression, as well as reduced well-being in adolescents and young adults, but similar associations in older adults have not been well studied, and longitudinal data are lacking, Ron H. Perlis, MD, of Massachusetts General Hospital, Boston, and colleagues wrote in their paper, which was published in JAMA Network Open.

To examine the association between social media use and depressive symptoms in older adults, the researchers reviewed data from 13 waves of an internet survey conducted each month between May 2020 and May 2021. The survey respondents included individuals aged 18 years and older, with a mean age of 56 years.

In the study the researchers analyzed responses from 5,395 individuals aged 18 years and older, with a mean age of 56 years. The study participants had minimal or no depressive symptoms at baseline, according to scores on the nine-item Patient Health Questionnaire (PHQ-9).

Overall, 8.9% of the respondents reported a worsening of 5 points or more on the PHQ-9 score on a follow-up survey, which was the primary outcome. Participants who reported using social media platforms Snapchat, Facebook, or TikTok were significantly more likely to report increased depressive symptoms, compared with those who did not report use of social media. The fully adjusted odds ratio was largest for Snapchat (aOR, 1.53), followed by Facebook (aOR, 1.42), and TikTok (aOR, 1.39).

Incorporating recent television and internet news terms, such as COVID-19, changed the association for Snapchat, for which the aOR decreased from 1.53 to 1.12 when news source terms were included in the survey. TikTok and Facebook associations remained similar.

When the results were further stratified by age, use of TikTok and Snapchat was associated with depressive symptoms in those aged 35 years and older, but not in those younger than 35 years. However, the opposite pattern emerged for Facebook; use was associated with depressive symptoms for individuals younger than 35 years, but not in those aged 35 years and older (aOR, 2.60 vs. aOR, 1.12).

The association between increased self-reported depressive symptoms and use of certain social media platforms was not impacted by baseline social support or face-to-face interactions, the researchers noted.
 

Family physician was surprised results weren’t more significant

In the current study, “I was honestly surprised the results weren’t more significant,” Mary Ann Dakkak, MD, of Boston University said in an interview. “That said, social media uses during the COVID pandemic may have been a necessary social outlet and form of connection for many people who were otherwise isolated.”

To still see a significant increase in depression when social media could have been a positive force may suggest a heavier impact during “normal” times, she added.

“It is not surprising that what we see in youth is shown among adults,” noted Dr. Dakkak, who was not involved with this study. “I always tell my patients that what is good for their children is good for the adults too, and vice versa.

“We expect to see outcomes of this on youth and adults who have been more isolated, who have used more screen time for learning, work, connection and boredom, in the near future,” she said. “The complex nature of why social media may have been used more heavily for connection during a time when in-person meetings were not possible may be a heavy confounder as the typical profile of heavy social media users may have differed during the COVID shutdowns.”
 

Psychiatrist: Balance benefits of social media with mental health risks

The current study was likely conducted before the recent news on “hidden” Facebook data and the implications that Facebook knew it was contributing to worsened mental health in teens, particularly around self-esteem, Jessica “Jessi” Gold, MD, a psychiatrist at Washington University, St. Louis, said in an interview.

“If you look more specifically at other studies, however, the data around social media and mental health is constantly varied, with some showing benefits and some showing negatives, and none conclusively suggesting either way,” said Dr. Gold, who also was not involved with the new research. “More data are needed, especially longitudinally and on a broader age group, to understand social media’s impact on mental health over time.

“It is also even more important in the wake of COVID-19, as so many people have turned to social media as a primary source of social support and connection, and are using it even more than before,” she emphasized.

In the current study, “I think the most interesting information is that, for TikTok and Snapchat, the effects seemed to be more pronounced in those older than 35 years who used social media,” said Dr. Gold.

What this study leaves unanswered is “whether people who might develop depression are simply more prone to use social media in the first place, such as to seek out social support,” Dr. Gold said. “Also, we don’t know anything about how long they are using social media or what they are using it for, which to me is important for understanding more about the nuance of the relationship with mental health and social media.”
 

Experts advise clinicians to discuss social media with patients

This new research suggests that clinicians should be talking to their patients about how social media impacts their emotional reactions, as well as their sleep, Dr. Gold said.

“Patients should be asking themselves how they are feeling when they are on social media and not using it before sleep. They should also be considering time limits and how to effectively use social media while taking care of their mental health,” she said. This conversation between clinician and patient should be had with any patient of any age, who uses social media, not only with teenagers.

“This is also a conversation about moderation, and knowing that individuals may feel they benefit from social media, that they should balance these benefits with potential mental health risks,” she said.

“Studies such as this one shed light onto why social media consumption should be at least a point of discussion with our patients,” said Dr. Dakkak.

She advised clinicians to ask and listen to patients and their families when it comes to screen time habits. “Whenever I see a patient with mood symptoms, I ask about their habits – eating, sleeping, socializing, screen time – including phone time. I ask about the family dynamics around screen time.

“I’ve added screen time to my adolescent assessment. Discussing safe use of cell phones and social media can have a significant impact on adolescent behavior and wellbeing, and parents are very thankful for the help,” she said. “This study encourages us to add screen time to the assessments we do at all adult ages, especially if mood symptoms exist,” Dr. Dakkak emphasized.
 

Suggestions for future research

Dr. Dakkak added that more areas for research include the differences in the impact of social media use on content creators versus content consumers. Also, “I would like to see research using the real data of use, the times of use, interruptions in sleep and use, possible confounding variables to include exercise, presence of intimate relationship and school/job performance.”

Given the many confounding variables, more controlled studies are needed to examine mental health outcomes in use, how long people use social media, and the impact of interventions such as time limits, Dr. Gold said.

“We can’t ignore the benefits of social media, such as helping those with social anxiety, finding peer support, and normalizing mental health, and those factors need to be studied and measured more effectively as well, she said.
 

Take-home message

It is important to recognize that the current study represents a correlation, not causality, said Dr. Gold. In addressing the issues of how social media impact mental health, “as always, the hardest thing is that many people get their news from social media, and often get social support from social media, so there has to be a balance of not removing social media completely, but of helping people see how it affects their mental health and how to find balance.”

The study findings were limited by several factors, including the inability to control for all potential confounders, the inability to assess the nature of social media use, and the lack of dose-response data, the researchers noted. Although the surveys in the current study were not specific to COVID-19, the effects of social media on depression may be specific to the content, and the findings may not generalize beyond the COVID-19 pandemic period.

Approximately two-thirds (66%) of the study participants identified as female, and 76% as White; 11% as Black; 6% as Asian; 5% as Hispanic; and 2% as American Indian or Alaska Native, Pacific Islander or Native Hawaiian, or other.

The National Institute of Mental Health provided a grant for the study to Dr. Pelis, who disclosed consulting fees from various companies and equity in Psy Therapeutics. The study’s lead author also serves as associate editor for JAMA Network Open, but was not involved in the decision process for publication of this study. Dr. Gold disclosed conducting a conference for Johnson & Johnson about social media and health care workers, and was on the advisory council.

The negative emotions stemming from teens’ involvement with social media have been grabbing the headlines. But adults may also be experiencing depression because of their use of social media, suggests a new study.

Use of social media has been linked to increased anxiety and depression, as well as reduced well-being in adolescents and young adults, but similar associations in older adults have not been well studied, and longitudinal data are lacking, Ron H. Perlis, MD, of Massachusetts General Hospital, Boston, and colleagues wrote in their paper, which was published in JAMA Network Open.

To examine the association between social media use and depressive symptoms in older adults, the researchers reviewed data from 13 waves of an internet survey conducted each month between May 2020 and May 2021. The survey respondents included individuals aged 18 years and older, with a mean age of 56 years.

In the study the researchers analyzed responses from 5,395 individuals aged 18 years and older, with a mean age of 56 years. The study participants had minimal or no depressive symptoms at baseline, according to scores on the nine-item Patient Health Questionnaire (PHQ-9).

Overall, 8.9% of the respondents reported a worsening of 5 points or more on the PHQ-9 score on a follow-up survey, which was the primary outcome. Participants who reported using social media platforms Snapchat, Facebook, or TikTok were significantly more likely to report increased depressive symptoms, compared with those who did not report use of social media. The fully adjusted odds ratio was largest for Snapchat (aOR, 1.53), followed by Facebook (aOR, 1.42), and TikTok (aOR, 1.39).

Incorporating recent television and internet news terms, such as COVID-19, changed the association for Snapchat, for which the aOR decreased from 1.53 to 1.12 when news source terms were included in the survey. TikTok and Facebook associations remained similar.

When the results were further stratified by age, use of TikTok and Snapchat was associated with depressive symptoms in those aged 35 years and older, but not in those younger than 35 years. However, the opposite pattern emerged for Facebook; use was associated with depressive symptoms for individuals younger than 35 years, but not in those aged 35 years and older (aOR, 2.60 vs. aOR, 1.12).

The association between increased self-reported depressive symptoms and use of certain social media platforms was not impacted by baseline social support or face-to-face interactions, the researchers noted.
 

Family physician was surprised results weren’t more significant

In the current study, “I was honestly surprised the results weren’t more significant,” Mary Ann Dakkak, MD, of Boston University said in an interview. “That said, social media uses during the COVID pandemic may have been a necessary social outlet and form of connection for many people who were otherwise isolated.”

To still see a significant increase in depression when social media could have been a positive force may suggest a heavier impact during “normal” times, she added.

“It is not surprising that what we see in youth is shown among adults,” noted Dr. Dakkak, who was not involved with this study. “I always tell my patients that what is good for their children is good for the adults too, and vice versa.

“We expect to see outcomes of this on youth and adults who have been more isolated, who have used more screen time for learning, work, connection and boredom, in the near future,” she said. “The complex nature of why social media may have been used more heavily for connection during a time when in-person meetings were not possible may be a heavy confounder as the typical profile of heavy social media users may have differed during the COVID shutdowns.”
 

Psychiatrist: Balance benefits of social media with mental health risks

The current study was likely conducted before the recent news on “hidden” Facebook data and the implications that Facebook knew it was contributing to worsened mental health in teens, particularly around self-esteem, Jessica “Jessi” Gold, MD, a psychiatrist at Washington University, St. Louis, said in an interview.

“If you look more specifically at other studies, however, the data around social media and mental health is constantly varied, with some showing benefits and some showing negatives, and none conclusively suggesting either way,” said Dr. Gold, who also was not involved with the new research. “More data are needed, especially longitudinally and on a broader age group, to understand social media’s impact on mental health over time.

“It is also even more important in the wake of COVID-19, as so many people have turned to social media as a primary source of social support and connection, and are using it even more than before,” she emphasized.

In the current study, “I think the most interesting information is that, for TikTok and Snapchat, the effects seemed to be more pronounced in those older than 35 years who used social media,” said Dr. Gold.

What this study leaves unanswered is “whether people who might develop depression are simply more prone to use social media in the first place, such as to seek out social support,” Dr. Gold said. “Also, we don’t know anything about how long they are using social media or what they are using it for, which to me is important for understanding more about the nuance of the relationship with mental health and social media.”
 

Experts advise clinicians to discuss social media with patients

This new research suggests that clinicians should be talking to their patients about how social media impacts their emotional reactions, as well as their sleep, Dr. Gold said.

“Patients should be asking themselves how they are feeling when they are on social media and not using it before sleep. They should also be considering time limits and how to effectively use social media while taking care of their mental health,” she said. This conversation between clinician and patient should be had with any patient of any age, who uses social media, not only with teenagers.

“This is also a conversation about moderation, and knowing that individuals may feel they benefit from social media, that they should balance these benefits with potential mental health risks,” she said.

“Studies such as this one shed light onto why social media consumption should be at least a point of discussion with our patients,” said Dr. Dakkak.

She advised clinicians to ask and listen to patients and their families when it comes to screen time habits. “Whenever I see a patient with mood symptoms, I ask about their habits – eating, sleeping, socializing, screen time – including phone time. I ask about the family dynamics around screen time.

“I’ve added screen time to my adolescent assessment. Discussing safe use of cell phones and social media can have a significant impact on adolescent behavior and wellbeing, and parents are very thankful for the help,” she said. “This study encourages us to add screen time to the assessments we do at all adult ages, especially if mood symptoms exist,” Dr. Dakkak emphasized.
 

Suggestions for future research

Dr. Dakkak added that more areas for research include the differences in the impact of social media use on content creators versus content consumers. Also, “I would like to see research using the real data of use, the times of use, interruptions in sleep and use, possible confounding variables to include exercise, presence of intimate relationship and school/job performance.”

Given the many confounding variables, more controlled studies are needed to examine mental health outcomes in use, how long people use social media, and the impact of interventions such as time limits, Dr. Gold said.

“We can’t ignore the benefits of social media, such as helping those with social anxiety, finding peer support, and normalizing mental health, and those factors need to be studied and measured more effectively as well, she said.
 

Take-home message

It is important to recognize that the current study represents a correlation, not causality, said Dr. Gold. In addressing the issues of how social media impact mental health, “as always, the hardest thing is that many people get their news from social media, and often get social support from social media, so there has to be a balance of not removing social media completely, but of helping people see how it affects their mental health and how to find balance.”

The study findings were limited by several factors, including the inability to control for all potential confounders, the inability to assess the nature of social media use, and the lack of dose-response data, the researchers noted. Although the surveys in the current study were not specific to COVID-19, the effects of social media on depression may be specific to the content, and the findings may not generalize beyond the COVID-19 pandemic period.

Approximately two-thirds (66%) of the study participants identified as female, and 76% as White; 11% as Black; 6% as Asian; 5% as Hispanic; and 2% as American Indian or Alaska Native, Pacific Islander or Native Hawaiian, or other.

The National Institute of Mental Health provided a grant for the study to Dr. Pelis, who disclosed consulting fees from various companies and equity in Psy Therapeutics. The study’s lead author also serves as associate editor for JAMA Network Open, but was not involved in the decision process for publication of this study. Dr. Gold disclosed conducting a conference for Johnson & Johnson about social media and health care workers, and was on the advisory council.

Treatment with intravenous ferric carboxymaltose significantly improved symptoms in restless legs syndrome (RLS) patients with iron-deficiency anemia (IDA), data from 29 adults show.

RLS occurs among individuals with normal iron but is at least six times higher among individuals with IDA, Hyoeun Bae, MD, of Keimyung University, Daegu, South Korea, and colleagues wrote. Previous studies have explored iron treatments for RLS patients with IDA, however, guidelines for treatment have not yet been published.

In a study published in Sleep Medicine, the researchers randomized 29 RLS patients with IDA to either 1,500 mg IV ferric carboxymaltose (FCM) or placebo for a short-term period of 6 weeks, followed by a phase 2 study for responders that lasted for 52 weeks. Baseline characteristics, including age, gender, iron parameters, and sleep and mood scales were similar between the groups.

At 6 weeks, patients in the FCM group showed significant improvement in RLS symptom severity based on changes from baseline International Restless Legs Syndrome Study Group scale (IRLS) scores, compared with placebo patients (–13.47 vs. 1.36, P < .001). A secondary outcome of sleep quality also improved significantly in the FCM group, compared with the placebo group.

After 6 weeks, 11 of the 14 patients in the placebo group also received 1,500 mg FCM for an open-label study. These patients also showed significant improvement in IRLS scores from baseline to 6 weeks.

All 23 responders from the short-term studies (13 who received FCM initially and 10 from the postplacebo group) enrolled in a phase 2 long-term study that lasted for 52 weeks; 14 of these completed the full 52-week study period.

Overall, 61% of participants in phase 2 of the study remained off their RLS medications at 52 weeks, and no serious adverse events were reported during the study period. Of these, 10 received one additional dose of FCM and 4 received more than one additional dose. The median change in IRLS score at 4 weeks after treatment was –4.00, compared with the score prior to treatment.

The study is the first of its design to show benefits of intravenous iron therapy for RLS in patients with IDA, the researchers said, noting that the findings of improved, but not cured, RLS symptoms might suggest that more than 1,500 mg of iron is needed to fully treat RLS in this patient population. “A second interpretation is that the RLS and IDA were separate events: a patient with idiopathic RLS who subsequently developed anemia,” they said. “Treating the IDA might improve symptoms but may not eliminate the symptoms.”

The study findings were limited by several factors, including the relatively small study population and inability to know the time frame for the development of IDA, the researchers noted. However, the results support the use of intravenous iron therapy for relief of RLS in IDA patients.

“Since IDA could result in epigenetic changes leading to irreversible state of RLS, then urgent and adequate management of the IDA in RLS patients would seem a very prudent and important clinical approach to this specific clinical condition,” they concluded.

The study received no outside funding. The researchers had no disclosures.

Treatment with intravenous ferric carboxymaltose significantly improved symptoms in restless legs syndrome (RLS) patients with iron-deficiency anemia (IDA), data from 29 adults show.

RLS occurs among individuals with normal iron but is at least six times higher among individuals with IDA, Hyoeun Bae, MD, of Keimyung University, Daegu, South Korea, and colleagues wrote. Previous studies have explored iron treatments for RLS patients with IDA, however, guidelines for treatment have not yet been published.

In a study published in Sleep Medicine, the researchers randomized 29 RLS patients with IDA to either 1,500 mg IV ferric carboxymaltose (FCM) or placebo for a short-term period of 6 weeks, followed by a phase 2 study for responders that lasted for 52 weeks. Baseline characteristics, including age, gender, iron parameters, and sleep and mood scales were similar between the groups.

At 6 weeks, patients in the FCM group showed significant improvement in RLS symptom severity based on changes from baseline International Restless Legs Syndrome Study Group scale (IRLS) scores, compared with placebo patients (–13.47 vs. 1.36, P < .001). A secondary outcome of sleep quality also improved significantly in the FCM group, compared with the placebo group.

After 6 weeks, 11 of the 14 patients in the placebo group also received 1,500 mg FCM for an open-label study. These patients also showed significant improvement in IRLS scores from baseline to 6 weeks.

All 23 responders from the short-term studies (13 who received FCM initially and 10 from the postplacebo group) enrolled in a phase 2 long-term study that lasted for 52 weeks; 14 of these completed the full 52-week study period.

Overall, 61% of participants in phase 2 of the study remained off their RLS medications at 52 weeks, and no serious adverse events were reported during the study period. Of these, 10 received one additional dose of FCM and 4 received more than one additional dose. The median change in IRLS score at 4 weeks after treatment was –4.00, compared with the score prior to treatment.

The study is the first of its design to show benefits of intravenous iron therapy for RLS in patients with IDA, the researchers said, noting that the findings of improved, but not cured, RLS symptoms might suggest that more than 1,500 mg of iron is needed to fully treat RLS in this patient population. “A second interpretation is that the RLS and IDA were separate events: a patient with idiopathic RLS who subsequently developed anemia,” they said. “Treating the IDA might improve symptoms but may not eliminate the symptoms.”

The study findings were limited by several factors, including the relatively small study population and inability to know the time frame for the development of IDA, the researchers noted. However, the results support the use of intravenous iron therapy for relief of RLS in IDA patients.

“Since IDA could result in epigenetic changes leading to irreversible state of RLS, then urgent and adequate management of the IDA in RLS patients would seem a very prudent and important clinical approach to this specific clinical condition,” they concluded.

The study received no outside funding. The researchers had no disclosures.

Treatment with intravenous ferric carboxymaltose significantly improved symptoms in restless legs syndrome (RLS) patients with iron-deficiency anemia (IDA), data from 29 adults show.

RLS occurs among individuals with normal iron but is at least six times higher among individuals with IDA, Hyoeun Bae, MD, of Keimyung University, Daegu, South Korea, and colleagues wrote. Previous studies have explored iron treatments for RLS patients with IDA, however, guidelines for treatment have not yet been published.

In a study published in Sleep Medicine, the researchers randomized 29 RLS patients with IDA to either 1,500 mg IV ferric carboxymaltose (FCM) or placebo for a short-term period of 6 weeks, followed by a phase 2 study for responders that lasted for 52 weeks. Baseline characteristics, including age, gender, iron parameters, and sleep and mood scales were similar between the groups.

At 6 weeks, patients in the FCM group showed significant improvement in RLS symptom severity based on changes from baseline International Restless Legs Syndrome Study Group scale (IRLS) scores, compared with placebo patients (–13.47 vs. 1.36, P < .001). A secondary outcome of sleep quality also improved significantly in the FCM group, compared with the placebo group.

After 6 weeks, 11 of the 14 patients in the placebo group also received 1,500 mg FCM for an open-label study. These patients also showed significant improvement in IRLS scores from baseline to 6 weeks.

All 23 responders from the short-term studies (13 who received FCM initially and 10 from the postplacebo group) enrolled in a phase 2 long-term study that lasted for 52 weeks; 14 of these completed the full 52-week study period.

Overall, 61% of participants in phase 2 of the study remained off their RLS medications at 52 weeks, and no serious adverse events were reported during the study period. Of these, 10 received one additional dose of FCM and 4 received more than one additional dose. The median change in IRLS score at 4 weeks after treatment was –4.00, compared with the score prior to treatment.

The study is the first of its design to show benefits of intravenous iron therapy for RLS in patients with IDA, the researchers said, noting that the findings of improved, but not cured, RLS symptoms might suggest that more than 1,500 mg of iron is needed to fully treat RLS in this patient population. “A second interpretation is that the RLS and IDA were separate events: a patient with idiopathic RLS who subsequently developed anemia,” they said. “Treating the IDA might improve symptoms but may not eliminate the symptoms.”

The study findings were limited by several factors, including the relatively small study population and inability to know the time frame for the development of IDA, the researchers noted. However, the results support the use of intravenous iron therapy for relief of RLS in IDA patients.

“Since IDA could result in epigenetic changes leading to irreversible state of RLS, then urgent and adequate management of the IDA in RLS patients would seem a very prudent and important clinical approach to this specific clinical condition,” they concluded.

The study received no outside funding. The researchers had no disclosures.

Adding lithium to usual care does not decrease the risk of suicide-related events in those with major depressive disorder (MDD) or bipolar disorder (BD) who have survived a recent suicidal event, new research shows.

The results of a randomized, double-blind, placebo-controlled trial in veterans showed no apparent advantage of the drug in preventing self-injury, suicide attempts, or urgent hospitalization to prevent suicide.

“Lithium is an important therapy for bipolar disorders and depression subsets. Our study indicates that, in patients who are actively followed and treated in a system of care that the VA provides, simply adding lithium to their existing management, including medications, is unlikely to be effective for preventing a broad range of suicide-related events,” study investigator Ryan Ferguson, MPH, ScD, Boston Cooperative Studies Coordinating Center, VA Boston Healthcare System, told this news organization.

The study was published online JAMA Psychiatry.
 

Surprising findings

The results were somewhat surprising, Dr. Ferguson added. “Lithium showed little or no effect in our study, compared to observational data and results from previous trials. Many clinicians and practice guidelines had assumed that lithium was an effective agent in preventing suicide,” he said.

However, the authors of an accompanying editorial urge caution in concluding that lithium has no antisuicidal effects.

This “rigorously designed and conducted trial has much to teach but cannot be taken as evidence that lithium treatment is ineffective regarding suicidal risk,” write Ross Baldessarini, MD, and Leonardo Tondo, MD, department of psychiatry, Harvard Medical School, Boston.

Study participants were veterans with MDD or BD receiving care at one of 29 Veterans Administration medical centers who survived a recent suicide-related event. In addition to usual care, they were randomly assigned to receive oral extended-release lithium carbonate starting at 600 mg/day or matching placebo for 52 weeks.

The primary outcome was time to the first repeated suicide-related event, including suicide attempts, interrupted attempts, hospitalizations specifically to prevent suicide, and deaths from suicide.

The trial was stopped for futility after 519 veterans (mean age, 42.8 years; 84% male) were randomly assigned to receive lithium (n = 255) or placebo (n = 264). At 3 months, mean lithium concentrations were 0.54 mEq/L for patients with BD and 0.46 mEq/L for those with MDD.

There was no significant difference in the primary outcome (hazard ratio, 1.10; 95% confidence interval, 0.77-1.55; P = .61).

A total of 127 participants (24.5%) had suicide-related outcomes – 65 in the lithium group and 62 in the placebo group. One death occurred in the lithium group and three in the placebo group. There were no unanticipated drug-related safety concerns.
 

Caveats, cautionary notes

The researchers note that the study did not reach its original recruitment goal. “One of the barriers to recruitment was the perception of many of the clinicians caring for potential participants that the effectiveness of lithium was already established; in fact, this perception was supported by the VA/U.S. Department of Defense Clinical Practice Guideline,” they point out.

They also note that most veterans in the study had depression rather than BD, which is the most common indication for lithium use. Most also had substance use disorders, posttraumatic stress disorder, or both, which could influence outcomes.

As a result of small numbers, it wasn’t possible to evaluate outcomes for patients with BD, test whether outcomes differed among patients with BD and MDD, or assess whether comorbidities attenuated the effects of lithium.

The study’s protocol increased participants’ contacts with the VA, which also may have affected outcomes, the researchers note.

In addition, high rates of attrition and low rates of substantial adherence to lithium meant only about half (48.1%) of the study population achieved target serum lithium concentrations.

Editorial writers Dr. Baldessarini and Dr. Tondo note that the low circulating concentrations of lithium and the fact that adherence to assigned treatment was considered adequate in only 17% of participants are key limitations of the study.

“In general, controlled treatment trials aimed at detecting suicide preventive effects are difficult to design, perform, and interpret,” they point out.

Evidence supporting an antisuicidal effect of lithium treatment includes nearly three dozen observational trials that have shown fewer suicides or attempts with lithium treatment, as well as “marked, temporary” increases in suicidal behavior soon after stopping lithium treatment.

Dr. Baldessarini and Dr. Tondo note the current findings “cannot be taken as evidence that lithium lacks antisuicidal effects. An ironic final note is that recruiting participants to such trials may be made difficult by an evidently prevalent belief that the question of antisuicidal effects of lithium is already settled, which it certainly is not,” they write.

Dr. Ferguson “agrees that more work needs to be done to understand the antisuicidal effect of lithium.

The study received financial and material support from a grant from the Cooperative Studies Program, Office of Research and Development, U.S. Department of Veterans Affairs. Dr. Ferguson has disclosed no relevant financial relationships. A complete list of author disclosures is available with the original article.

Dr. Baldessarini and Dr. Tondo have disclosed no relevant financial relationships. Their editorial was supported by grants from the Bruce J. Anderson Foundation, the McLean Private Donors Fund for Psychiatric Research, and the Aretaeus Foundation of Rome.

A version of this article first appeared on Medscape.com.

Adding lithium to usual care does not decrease the risk of suicide-related events in those with major depressive disorder (MDD) or bipolar disorder (BD) who have survived a recent suicidal event, new research shows.

The results of a randomized, double-blind, placebo-controlled trial in veterans showed no apparent advantage of the drug in preventing self-injury, suicide attempts, or urgent hospitalization to prevent suicide.

“Lithium is an important therapy for bipolar disorders and depression subsets. Our study indicates that, in patients who are actively followed and treated in a system of care that the VA provides, simply adding lithium to their existing management, including medications, is unlikely to be effective for preventing a broad range of suicide-related events,” study investigator Ryan Ferguson, MPH, ScD, Boston Cooperative Studies Coordinating Center, VA Boston Healthcare System, told this news organization.

The study was published online JAMA Psychiatry.
 

Surprising findings

The results were somewhat surprising, Dr. Ferguson added. “Lithium showed little or no effect in our study, compared to observational data and results from previous trials. Many clinicians and practice guidelines had assumed that lithium was an effective agent in preventing suicide,” he said.

However, the authors of an accompanying editorial urge caution in concluding that lithium has no antisuicidal effects.

This “rigorously designed and conducted trial has much to teach but cannot be taken as evidence that lithium treatment is ineffective regarding suicidal risk,” write Ross Baldessarini, MD, and Leonardo Tondo, MD, department of psychiatry, Harvard Medical School, Boston.

Study participants were veterans with MDD or BD receiving care at one of 29 Veterans Administration medical centers who survived a recent suicide-related event. In addition to usual care, they were randomly assigned to receive oral extended-release lithium carbonate starting at 600 mg/day or matching placebo for 52 weeks.

The primary outcome was time to the first repeated suicide-related event, including suicide attempts, interrupted attempts, hospitalizations specifically to prevent suicide, and deaths from suicide.

The trial was stopped for futility after 519 veterans (mean age, 42.8 years; 84% male) were randomly assigned to receive lithium (n = 255) or placebo (n = 264). At 3 months, mean lithium concentrations were 0.54 mEq/L for patients with BD and 0.46 mEq/L for those with MDD.

There was no significant difference in the primary outcome (hazard ratio, 1.10; 95% confidence interval, 0.77-1.55; P = .61).

A total of 127 participants (24.5%) had suicide-related outcomes – 65 in the lithium group and 62 in the placebo group. One death occurred in the lithium group and three in the placebo group. There were no unanticipated drug-related safety concerns.
 

Caveats, cautionary notes

The researchers note that the study did not reach its original recruitment goal. “One of the barriers to recruitment was the perception of many of the clinicians caring for potential participants that the effectiveness of lithium was already established; in fact, this perception was supported by the VA/U.S. Department of Defense Clinical Practice Guideline,” they point out.

They also note that most veterans in the study had depression rather than BD, which is the most common indication for lithium use. Most also had substance use disorders, posttraumatic stress disorder, or both, which could influence outcomes.

As a result of small numbers, it wasn’t possible to evaluate outcomes for patients with BD, test whether outcomes differed among patients with BD and MDD, or assess whether comorbidities attenuated the effects of lithium.

The study’s protocol increased participants’ contacts with the VA, which also may have affected outcomes, the researchers note.

In addition, high rates of attrition and low rates of substantial adherence to lithium meant only about half (48.1%) of the study population achieved target serum lithium concentrations.

Editorial writers Dr. Baldessarini and Dr. Tondo note that the low circulating concentrations of lithium and the fact that adherence to assigned treatment was considered adequate in only 17% of participants are key limitations of the study.

“In general, controlled treatment trials aimed at detecting suicide preventive effects are difficult to design, perform, and interpret,” they point out.

Evidence supporting an antisuicidal effect of lithium treatment includes nearly three dozen observational trials that have shown fewer suicides or attempts with lithium treatment, as well as “marked, temporary” increases in suicidal behavior soon after stopping lithium treatment.

Dr. Baldessarini and Dr. Tondo note the current findings “cannot be taken as evidence that lithium lacks antisuicidal effects. An ironic final note is that recruiting participants to such trials may be made difficult by an evidently prevalent belief that the question of antisuicidal effects of lithium is already settled, which it certainly is not,” they write.

Dr. Ferguson “agrees that more work needs to be done to understand the antisuicidal effect of lithium.

The study received financial and material support from a grant from the Cooperative Studies Program, Office of Research and Development, U.S. Department of Veterans Affairs. Dr. Ferguson has disclosed no relevant financial relationships. A complete list of author disclosures is available with the original article.

Dr. Baldessarini and Dr. Tondo have disclosed no relevant financial relationships. Their editorial was supported by grants from the Bruce J. Anderson Foundation, the McLean Private Donors Fund for Psychiatric Research, and the Aretaeus Foundation of Rome.

A version of this article first appeared on Medscape.com.

Adding lithium to usual care does not decrease the risk of suicide-related events in those with major depressive disorder (MDD) or bipolar disorder (BD) who have survived a recent suicidal event, new research shows.

The results of a randomized, double-blind, placebo-controlled trial in veterans showed no apparent advantage of the drug in preventing self-injury, suicide attempts, or urgent hospitalization to prevent suicide.

“Lithium is an important therapy for bipolar disorders and depression subsets. Our study indicates that, in patients who are actively followed and treated in a system of care that the VA provides, simply adding lithium to their existing management, including medications, is unlikely to be effective for preventing a broad range of suicide-related events,” study investigator Ryan Ferguson, MPH, ScD, Boston Cooperative Studies Coordinating Center, VA Boston Healthcare System, told this news organization.

The study was published online JAMA Psychiatry.
 

Surprising findings

The results were somewhat surprising, Dr. Ferguson added. “Lithium showed little or no effect in our study, compared to observational data and results from previous trials. Many clinicians and practice guidelines had assumed that lithium was an effective agent in preventing suicide,” he said.

However, the authors of an accompanying editorial urge caution in concluding that lithium has no antisuicidal effects.

This “rigorously designed and conducted trial has much to teach but cannot be taken as evidence that lithium treatment is ineffective regarding suicidal risk,” write Ross Baldessarini, MD, and Leonardo Tondo, MD, department of psychiatry, Harvard Medical School, Boston.

Study participants were veterans with MDD or BD receiving care at one of 29 Veterans Administration medical centers who survived a recent suicide-related event. In addition to usual care, they were randomly assigned to receive oral extended-release lithium carbonate starting at 600 mg/day or matching placebo for 52 weeks.

The primary outcome was time to the first repeated suicide-related event, including suicide attempts, interrupted attempts, hospitalizations specifically to prevent suicide, and deaths from suicide.

The trial was stopped for futility after 519 veterans (mean age, 42.8 years; 84% male) were randomly assigned to receive lithium (n = 255) or placebo (n = 264). At 3 months, mean lithium concentrations were 0.54 mEq/L for patients with BD and 0.46 mEq/L for those with MDD.

There was no significant difference in the primary outcome (hazard ratio, 1.10; 95% confidence interval, 0.77-1.55; P = .61).

A total of 127 participants (24.5%) had suicide-related outcomes – 65 in the lithium group and 62 in the placebo group. One death occurred in the lithium group and three in the placebo group. There were no unanticipated drug-related safety concerns.
 

Caveats, cautionary notes

The researchers note that the study did not reach its original recruitment goal. “One of the barriers to recruitment was the perception of many of the clinicians caring for potential participants that the effectiveness of lithium was already established; in fact, this perception was supported by the VA/U.S. Department of Defense Clinical Practice Guideline,” they point out.

They also note that most veterans in the study had depression rather than BD, which is the most common indication for lithium use. Most also had substance use disorders, posttraumatic stress disorder, or both, which could influence outcomes.

As a result of small numbers, it wasn’t possible to evaluate outcomes for patients with BD, test whether outcomes differed among patients with BD and MDD, or assess whether comorbidities attenuated the effects of lithium.

The study’s protocol increased participants’ contacts with the VA, which also may have affected outcomes, the researchers note.

In addition, high rates of attrition and low rates of substantial adherence to lithium meant only about half (48.1%) of the study population achieved target serum lithium concentrations.

Editorial writers Dr. Baldessarini and Dr. Tondo note that the low circulating concentrations of lithium and the fact that adherence to assigned treatment was considered adequate in only 17% of participants are key limitations of the study.

“In general, controlled treatment trials aimed at detecting suicide preventive effects are difficult to design, perform, and interpret,” they point out.

Evidence supporting an antisuicidal effect of lithium treatment includes nearly three dozen observational trials that have shown fewer suicides or attempts with lithium treatment, as well as “marked, temporary” increases in suicidal behavior soon after stopping lithium treatment.

Dr. Baldessarini and Dr. Tondo note the current findings “cannot be taken as evidence that lithium lacks antisuicidal effects. An ironic final note is that recruiting participants to such trials may be made difficult by an evidently prevalent belief that the question of antisuicidal effects of lithium is already settled, which it certainly is not,” they write.

Dr. Ferguson “agrees that more work needs to be done to understand the antisuicidal effect of lithium.

The study received financial and material support from a grant from the Cooperative Studies Program, Office of Research and Development, U.S. Department of Veterans Affairs. Dr. Ferguson has disclosed no relevant financial relationships. A complete list of author disclosures is available with the original article.

Dr. Baldessarini and Dr. Tondo have disclosed no relevant financial relationships. Their editorial was supported by grants from the Bruce J. Anderson Foundation, the McLean Private Donors Fund for Psychiatric Research, and the Aretaeus Foundation of Rome.

A version of this article first appeared on Medscape.com.

U.S. regulators have put some of the new clozapine risk evaluation and mitigation strategy (REMS) program on temporary hold because of start-up difficulties, including long telephone wait times.

In a Nov. 19 statement, the Food and Drug Administration announced it is temporarily suspending certain aspects of the program because of challenges reported by medical professionals who were trying to meet the original Nov. 15 deadline.

In response, the FDA has conceded that pharmacists can dispense clozapine without a REMS dispense authorization (RDA). Wholesalers can continue to ship clozapine to pharmacies and health care settings without confirming enrollment in the REMS, the FDA also said.

“We encourage pharmacists and prescribers to continue working with the clozapine REMS to complete certification and patient enrollment,” the FDA said in a statement.

In July, the FDA approved modifications to the clozapine REMS strategy. Clozapine is used to treat schizophrenia that is not well controlled with standard antipsychotics. It is also prescribed to patients with recurrent suicidal behavior associated with schizophrenia or schizoaffective disorder.

Although it is highly effective in some patients, it also carries serious risks. Specifically, it can decrease the neutrophil count, which can lead to severe neutropenia, serious infections, and death.

As a result, those taking the drug must undergo regular absolute neutrophil count (ANC) monitoring. Clozapine REMS is intended to maximize the benefits of the drug and minimize risk.

HCP frustration

In its statement, the FDA said medical professionals had alerted the agency about ongoing difficulties with the clozapine REMS program, including a high call volume and long call wait times for stakeholders.

“We understand that this has caused frustration and has led to patient access issues for clozapine,” the FDA said in a statement.

“Continuity of care, patient access to clozapine, and patient safety are our highest priorities,” the FDA added. “We are working closely with the clozapine REMS program administrators to address these challenges and avoid interruptions in patient care.”

Abrupt discontinuation of clozapine can result in significant complications, the FDA said. The agency urged use of “clinical judgment” with respect to prescribing and dispensing clozapine to patients with an absolute neutrophil count within the acceptable range.

As previously reported by this news organization, the American Psychiatric Association and other national groups in a September letter asked the FDA to delay the implementation of a new REMS program until after Jan. 1, 2022.

A version of this article first appeared on Medscape.com.

U.S. regulators have put some of the new clozapine risk evaluation and mitigation strategy (REMS) program on temporary hold because of start-up difficulties, including long telephone wait times.

In a Nov. 19 statement, the Food and Drug Administration announced it is temporarily suspending certain aspects of the program because of challenges reported by medical professionals who were trying to meet the original Nov. 15 deadline.

In response, the FDA has conceded that pharmacists can dispense clozapine without a REMS dispense authorization (RDA). Wholesalers can continue to ship clozapine to pharmacies and health care settings without confirming enrollment in the REMS, the FDA also said.

“We encourage pharmacists and prescribers to continue working with the clozapine REMS to complete certification and patient enrollment,” the FDA said in a statement.

In July, the FDA approved modifications to the clozapine REMS strategy. Clozapine is used to treat schizophrenia that is not well controlled with standard antipsychotics. It is also prescribed to patients with recurrent suicidal behavior associated with schizophrenia or schizoaffective disorder.

Although it is highly effective in some patients, it also carries serious risks. Specifically, it can decrease the neutrophil count, which can lead to severe neutropenia, serious infections, and death.

As a result, those taking the drug must undergo regular absolute neutrophil count (ANC) monitoring. Clozapine REMS is intended to maximize the benefits of the drug and minimize risk.

HCP frustration

In its statement, the FDA said medical professionals had alerted the agency about ongoing difficulties with the clozapine REMS program, including a high call volume and long call wait times for stakeholders.

“We understand that this has caused frustration and has led to patient access issues for clozapine,” the FDA said in a statement.

“Continuity of care, patient access to clozapine, and patient safety are our highest priorities,” the FDA added. “We are working closely with the clozapine REMS program administrators to address these challenges and avoid interruptions in patient care.”

Abrupt discontinuation of clozapine can result in significant complications, the FDA said. The agency urged use of “clinical judgment” with respect to prescribing and dispensing clozapine to patients with an absolute neutrophil count within the acceptable range.

As previously reported by this news organization, the American Psychiatric Association and other national groups in a September letter asked the FDA to delay the implementation of a new REMS program until after Jan. 1, 2022.

A version of this article first appeared on Medscape.com.

U.S. regulators have put some of the new clozapine risk evaluation and mitigation strategy (REMS) program on temporary hold because of start-up difficulties, including long telephone wait times.

In a Nov. 19 statement, the Food and Drug Administration announced it is temporarily suspending certain aspects of the program because of challenges reported by medical professionals who were trying to meet the original Nov. 15 deadline.

In response, the FDA has conceded that pharmacists can dispense clozapine without a REMS dispense authorization (RDA). Wholesalers can continue to ship clozapine to pharmacies and health care settings without confirming enrollment in the REMS, the FDA also said.

“We encourage pharmacists and prescribers to continue working with the clozapine REMS to complete certification and patient enrollment,” the FDA said in a statement.

In July, the FDA approved modifications to the clozapine REMS strategy. Clozapine is used to treat schizophrenia that is not well controlled with standard antipsychotics. It is also prescribed to patients with recurrent suicidal behavior associated with schizophrenia or schizoaffective disorder.

Although it is highly effective in some patients, it also carries serious risks. Specifically, it can decrease the neutrophil count, which can lead to severe neutropenia, serious infections, and death.

As a result, those taking the drug must undergo regular absolute neutrophil count (ANC) monitoring. Clozapine REMS is intended to maximize the benefits of the drug and minimize risk.

HCP frustration

In its statement, the FDA said medical professionals had alerted the agency about ongoing difficulties with the clozapine REMS program, including a high call volume and long call wait times for stakeholders.

“We understand that this has caused frustration and has led to patient access issues for clozapine,” the FDA said in a statement.

“Continuity of care, patient access to clozapine, and patient safety are our highest priorities,” the FDA added. “We are working closely with the clozapine REMS program administrators to address these challenges and avoid interruptions in patient care.”

Abrupt discontinuation of clozapine can result in significant complications, the FDA said. The agency urged use of “clinical judgment” with respect to prescribing and dispensing clozapine to patients with an absolute neutrophil count within the acceptable range.

As previously reported by this news organization, the American Psychiatric Association and other national groups in a September letter asked the FDA to delay the implementation of a new REMS program until after Jan. 1, 2022.

A version of this article first appeared on Medscape.com.