APA Criticizes Tax Bill as Unnecessary Attack on Nation’s Health Care

Congressional Republicans along with President Donald J. Trump celebrated the final passage today of a sweeping tax reform bill that slashes corporate taxes while also gutting the central tenet of the Affordable Care Act. Expressing disappointment, APA said the bill causes “unnecessary damage” to the nation’s health care system.

The core of the Tax Cuts and Jobs Act is a huge cut to the corporate tax rate, dropping it from 35% to 21%. The measure also cuts individual tax rates for all income tax levels, with most of the benefits going to those earning more than $300,000, according to the nonpartisan Tax Policy Center.

The final bill passed the House 224-201, with no Democrats backing it and 12 Republicans dissenting. The president is expected to sign the bill into law as soon as it is enrolled.

Repeal of the individual mandate in the Affordable Care Act “sacrifices the health care of 13 million Americans who will lose their insurance by 2027,” said APA CEO and Medical Director Saul Levin, M.D., M.P.A., in a press statement. The change is projected to save the government $300 billion over a decade.

“By significantly raising the federal deficit, this bill sets the stage for future cuts to Medicare and other critical safety net programs,” Levin continued. “What is being sold as a tax cut bill is also an attack on our health care system. There is no reason for these two issues to be decided by the same vote.”

According to a coalition of six physician organizations of which APA is a member, repealing the individual mandate will increase premiums and destabilize the individual and small group markets. People with mental illness were more likely to be insured after the implementation of the ACA (5% versus 13%), according to a recent APA survey.

“We need Congress to pass legislation that will stabilize the ACA markets and shore up our health care system,” Levin said. “We stand ready to work with Congress on a thoughtful, bipartisan approach to health care reform.”

The measure leaves untouched health savings accounts. These are savings accounts linked to high-deductible health insurance plans and exempt from tax liability.

This is the last issue of the PN Alert for 2017; Alerts will resume publication on Tuesday, January 2. Happy Holidays!

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Cannabidiol May Be Effective Adjunct to Antipsychotic Treatment for Schizophrenia Patients

Patients with schizophrenia who are prescribed cannabidiol (CBD) in addition to antipsychotics may experience lower levels of positive psychotic symptoms compared with those taking antipsychotics alone, according to a report in AJP in Advance. The study also found that use of CBD as an adjunctive therapy for this population may also improve cognitive performance and overall functioning.

“Because CBD acts in a way different from conventional antipsychotic medication, it may represent a new class of treatment for schizophrenia,” wrote Philip McGuire, M.D., of the Institute of Psychiatry, Psychology, and Neuroscience at King's College London and colleagues. “However, its potential clinical utility will require further investigation in larger-scale trials.”

McGuire and colleagues recruited patients with schizophrenia who had previously demonstrated at least a partial response to antipsychotic medication and had been receiving a stable dose of antipsychotic medication for at least four weeks. A total of 88 patients were randomly assigned to take cannabidiol (1000 mg/day; n=43) or placebo (n=45) in addition to their existing antipsychotic medication.

The researchers evaluated patients’ symptoms, general functioning, and cognitive performance, among other measures at baseline and on days 8, 22, and 43. Clinicians also recorded impressions of patient severity, improvement, and general functioning.

After six weeks, patients in the CBD group experienced a greater reduction in positive psychotic symptoms (measured using the Positive and Negative Syndrome Scale) from baseline compared with the placebo group. At the end of treatment, a significantly higher proportion of patients in the CBD group were rated by their clinician as “improved” on the Clinical Global Impression scale compared with those in the placebo group (78.6% and 54.6%, respectively).

Cognitive performance, as measured by the Brief Cognitive Assessment Scale (BACS), was also greater among patients receiving cannabidiol, although it fell short of statistical significance. However, analysis of the individual BACS domains showed that there was a significantly greater improvement in motor speed in the cannabidiol group compared with the placebo group.

CBD was well tolerated, and rates of adverse events were similar between the CBD and placebo groups.

For related information, see the Psychiatric News article “Cannabidiol May Benefit Patients With Early Psychosis, Cannabis Misuse.”

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Rise in Antidepressant Prescriptions for Youth Raises Questions About Why

The number of prescriptions of antidepressants for children and adolescents fell after the Food and Drug Administration in 2004 directed pharmaceutical companies to issue a black-box warning about the potential link between antidepressant use and the risk of increased suicidal ideation among youth. A study published in Psychiatric Services now shows that following that initial decline, the rate of antidepressant prescribing to children returned to pre-2004 levels within a few years. 

Nilay Kafali, Ph.D., of RTI International and colleagues found that 2.26% of children aged 5 to 17 were prescribed antidepressants in 2009, similar to the 2003 level of 2.29%. Between 2004 and 2008, that rate had dropped to below 2%.

The authors calculated these rates using data from the Medical Expenditure Panel Survey (a set of nationally representative surveys of individuals, medical providers, and employers that detail the usage and costs of health care services and health insurance coverage). They included available data on children aged 5 to 17 between 2000 and 2011. To estimate how the impact of the black-box warning on antidepressant use among children changed over time, the authors divided the entire sample period into four periods: early prewarning (2000–2001), prewarning (2002–2003), early postwarning (2004–2007), and late postwarning (2008–2011). 

They found that there was a 0.5% statistically significant decline in antidepressant use during the early postwarning years compared with prewarning years, with a particularly strong decrease among children rated as having non-severe psychological impairment (which the authors defined as a Columbia impairment Scale score of <16). By 2009, though, the rates had returned to pre-2004 levels.

“These findings suggest that providers and families of youths may have reacted to the black-box warning in an appropriate manner, weighing the warning with the risks and benefits of the treatment,” Kafali and colleagues wrote. “A return to the rates of antidepressant use before the black-box warning raises concern that this thoughtful accounting of the risks and benefits may have dissipated over time.”

“It is possible that over time physicians have become somewhat inured to the safety warnings,” said Mark Olfson, M.D., M.P.H., a professor of psychiatry and epidemiology at Columbia University Medical Center, who was not involved with this study. “However, it is also possible that increasing prevalence of depression or anxiety among young people during the great recession played a role,” he added.

Olfson, who was not involved with this study, noted that other community surveys including the Youth Risk Behavior Survey, the National Survey on Drug Use and Health, and the Monitoring the Future surveys have revealed a recent increase in depressed mood and major depressive episodes among children and adolescents. 

For related information, see the Psychiatric News article “U.S. Experiences Uptick in Rates of Suicide.”

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Study Examines Relationship Between History of SSRI Use By Dads, ADHD in Offspring

A study published this week in Pediatrics suggests that children whose fathers took selective serotonin reuptake inhibitors (SSRIs) before the children were conceived may be more likely to develop attention-deficit/hyperactivity disorder (ADHD) than those whose fathers did not take SSRIs. However, the study authors cautioned that this increased risk may be due in part to the fathers’ underlying mental health disorder related to their SSRI use.

To examine the risk of ADHD in children whose fathers took SSRIs within three months of conception, researchers at the University in Shanghai and Aarhus University Hospital in Denmark conducted a nationwide cohort study of children born in Denmark between 1996 and 2008. The authors focused on the three-month cut off because it takes sperm roughly 70 to 90 days to fully mature (several studies have suggested that SSRIs may compromise sperm, which is associated with increased risk of disease in offspring). Children were followed from age 3 until the first diagnosis of ADHD, death, emigration, or December 31, 2013, whichever came first.

Among the 781,470 single births included in the study, 12,520 children were later diagnosed with ADHD. A total of 7,216 children were born to fathers who had used SSRIs during the last three months before conception.

Compared with children whose fathers did not take SSRIs during the period examined, the exposed children had a 26% increased risk of ADHD after adjustment for potential confounders, according to the authors. When the researchers compared the ADHD rates in offspring of men who took SSRIs three to 12 months before conception with those who took SSRIs within the three-month period before conception, they found that both groups displayed roughly equivalent risks of having children with ADHD.

Further, when the authors analyzed data from families with more than one child and with at least one child with paternal SSRI preconception exposure, they found the risk of ADHD in exposed children decreased when compared with their unexposed siblings (adjusted hazard ratio=0.68).

“On the basis of these results, the authors concluded that although there is some increased risk among SSRI users, the underlying paternal mental health disease may itself be a risk factor for ADHD in offspring,” wrote Craig F. Garfield, M.D., of Northwestern University Feinberg School of Medicine in a related editorial.

“From a clinical perspective, this study reinforces the importance of identifying mental health disorders among men transitioning to fatherhood and among current fathers,” Garfield said. “[P]roviding treatment of fathers’ underlying mental health disorders may improve fathers’ and families’ functioning, ultimately improving their children’s outcomes.”

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Federal Agencies Must Provide Better Care for People With SMI, Says SAMHSA Report

Too many individuals with serious mental illness (SMI) are not getting the treatment and support they need because of fragmented federal systems that are providing inadequate services, according to the first report by a federal committee tasked with improving care for this population. The report was delivered to Congress and issued to the public today.

The Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC) was created as part of the 21st Century Cures Act. It aims to enhance coordination across federal agencies that impact the care of adults and youth with SMI. Serious mental illness is defined as a mental illness that seriously impacts the ability to work, live, or form relationships with others.

The report noted that there were 10 million American adults living with a serious mental illness in 2016, and 35% received no treatment. More than 7 million youth experienced a serious emotional disturbance (SED). Both populations face a greater risk of suicide and a life expectancy 10 years shorter than that of the general population. Because of inadequate mental health resources, 2 million people with SMI are incarcerated each year. 

The committee brings together representatives from eight federal government departments that support programs for individuals with SMI or SED, including the departments of Health and Human Services (HHS); Justice; Labor; and Housing and Urban Development, along with nonfederal members including researchers, advocates, and health care professionals. 

“Too often, people with SMI or SED lack access to evidence-based treatments, so they experience high rates of homelessness, joblessness, disability, involvement with the criminal justice system, premature death, and other negative outcomes,” said Elinore F. McCance-Katz, M.D., Ph.D., assistant secretary for mental health and substance use at HHS, head of the Substance Abuse and Mental Health Services Administration, and chair of ISMICC. “Our health care system can do better, and the federal government can marshal its resources to help make that happen.”

The committee offered five basic recommendations on how the federal government could improve the care it provides and the outcomes for this population: strengthen federal coordination between departments to allow for better care, improve access and engagement to make it easier to get high-quality care, close the gap between effective treatments that are known to work and what is actually offered, boost diversion from and treatment for people with SMI in the criminal and juvenile justice systems, and develop finance strategies to make care more available and affordable. 

APA welcomed the report and is looking forward to seeing the responses of federal agencies. “Our members are ready to work with the administration and Congress to implement the recommendations made today,” APA CEO and Medical Director Saul Levin, M.D., M.P.A., in a press statement. “Our patients deserve the best care possible, and today’s report is a step in the right direction.”

ISMICC is required to issue a second report to Congress in four years. 

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Folate, Vitamin D Found Lower in People Who Have Experienced First-Episode Psychosis

Patients who have experienced first-episode psychosis (FEP) appear to have significantly lower levels of folate and vitamin D in their blood compared with individuals with no psychiatric diagnosis, according to a report in Schizophrenia Bulletin.

Understanding nutritional deficits that exist from illness onset could lead to nutrient-based interventions to improve diet and possibly reduce symptoms in people with FEP, the authors wrote.

Previous studies have suggested that individuals with schizophrenia have low levels of B vitamins (B12 and folate), antioxidant vitamins (C and E), and vitamin D. However, which nutritional deficiencies are present at the first episode of psychosis was previously unknown.

Joseph Firth, Ph.D., of the University of Western Sydney and colleagues analyzed data from 28 studies that compared the blood levels of vitamins and minerals of people with and without FEP. These studies, which included 2,612 individuals (1,221 people with FEP and 1,391 controls), assessed differences in blood levels of six vitamins (A, B12, C, D, E, and folate) and 10 minerals (calcium, chromium, copper, iron, magnesium, manganese, potassium, selenium, sodium, and zinc).

The meta-analysis revealed significant reductions in folate and vitamin D among people with FEP compared with nonpsychiatric controls, with the strongest evidence found for vitamin D deficits. Lower folate and vitamin D levels were also found to be associated with more severe symptomology in individuals with FEP.

Although only examined in two studies, vitamin C was also significantly reduced in patients with FEP. There were no significant differences between people with and without FEP with regard to the levels of other vitamins and minerals—a finding that could be due to the fact that some of the studies of other nutrients included only a small number of people with FEP, the authors said.

“Further longitudinal and interventional research in individuals identified at ‘ultra-high risk’ for psychosis would provide valuable insights into both the predictive value of nutritional deficiencies in the onset of psychosis, along with potentially determining if nutritional supplementation can confer any benefit for reducing psychosis risk,” Firth and colleagues conclude.

For related news, see the Psychiatric News articles “D.C. Psychiatric Society Hosts Panel on Nutrition and Psychiatry” and “Long Career Studying Choline Leads to Public Health Payoff.”

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Incorporating Social Therapy Into Early Psychosis Intervention Improves Social Engagement

Despite considerable evidence showing the benefit of early intervention services on social recovery in people with first-episode psychosis, many will continue to experience severe and persistent social impairments. A study published yesterday in Lancet Psychiatry suggests that combining early psychosis intervention with social recovery therapy may help to further improve patient outcomes, particularly in individuals who lack the motivation or ability to engage in existing psychosocial interventions.

The social recovery program examined in the study was a three-step approach aimed at (1) establishing a working therapeutic relationship and assessing patient goals, (2) working together to identify ways to initiate meaningful new activities, and (3) engaging in new activities and fostering a sense of mastery and agency in the patient.

David Fowler, M.Sc., of the University of Sussex and colleagues recruited patients aged 16 to 35 with non-affective psychosis who had participated in early intervention services for 12 to 30 months and had low levels of structured activity (defined as ≤30 h/week on the Time Use Survey). Structured activities assessed by the Time Use Survey include work, education, voluntary work, leisure, sports, housework or chores, and child care.

The researchers assigned 155 patients to either early intervention services alone or in combination with social recovery therapy for nine months. 

After nine months, participants who received both psychosis intervention and social therapy engaged in eight more hours of structured activities each week compared with those receiving only early intervention.

“The effect size after treatment is clearly of clinical benefit, especially given the extreme social withdrawal present at baseline,” wrote Fowler and colleagues. They noted that the participants only engaged in around 12 hours of activities per week at baseline. “The size of the effect is twice that identified by consensus groups of users and clinicians as the minimum clinically important difference and represents an amount of activity equivalent to a working day.”

A secondary analysis to see if these improvements persisted six months after the treatments ended (15 months post-baseline) was inconclusive. The authors noted that this may have been due to a high amount of patient dropout after the interventions ended.

For related information, see the Psychiatric News article “Psychosocial Treatments Found Effective for Early Psychosis” and the Psychiatric Services article “Providing Recovery-Oriented Early Intervention Services to Youths Experiencing First-Episode Psychosis.”

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Pregnant Women With Dissociative Subtype of PTSD Have Higher Levels of Cortisol, Study Finds

Pregnant women with a severe subtype of posttraumatic stress disorder (PTSD) appear to have higher levels of the stress hormone cortisol than other pregnant women with a history of trauma, reports a study in the Journal of Obstetric, Gynecological, and Neonatal Nursing. Such high levels of cortisol may contribute to adverse health conditions in the next generation, according to the study authors.

“Exposure to early relational trauma that predisposes a person to dissociation and PTSD may affect that individual’s short- and long-term cortisol patterns,” wrote Julia S. Seng, Ph.D., of the University of Michigan and colleagues. Previous studies suggest that elevated cortisol levels are a risk factor for preterm birth, affecting the onset of labor and inflammatory processes.

A diagnosis of PTSD may include a dissociative subtype (PTSD-D) characterized by altered perception of oneself and the world. PTSD-D is associated with a greater number of lifetime trauma exposures, including a history of childhood maltreatment.

The study by Seng and colleagues involved 395 women expecting their first child who were divided into four groups: those without trauma, those with a trauma but no PTSD, those with lifetime PTSD, and those with PTSD-D (presence of depersonalization and/or derealization consistent with the DSM-5 dissociative subtype definition). The researchers analyzed saliva cortisol specimens collected by these women at three different times on a single day during the first half of their pregnancy. A subsample of 111 women, including women from each of the four cohorts, provided three salivary cortisol specimens per day, 12 times, from early pregnancy to six weeks postpartum for longitudinal data (This sample included 34 women without trauma, 38 with trauma but no PTSD, 31 with PTSD only, and eight with PTSD-D).

In early pregnancy (gestational week 8), the cortisol levels of participants in the PTSD-D group were two times greater in the morning, eight times greater in the afternoon, and 10 times greater at bedtime than the cortisol levels of participants in the non-exposed control group. In late pregnancy (gestational week 32), participants in the PTSD-D group had cortisol levels that were less than two times greater in the morning and 1.5 times greater levels in the afternoon and at bedtime compared with participants in the non-exposed control group. The difference between the PTSD-D and the other groups was most apparent in early pregnancy, which is a critical period for fetal development, noted the authors.

“Although some women with histories of childhood maltreatment are resilient or recovered by the time they become pregnant, these biological findings indicate that some are very adversely affected psychologically and very stressed during the childbearing year,” the authors wrote. “We can screen and apply a stepped approach to maternity care that includes case-finding and interventions for women with PTSD, posttraumatic depression, and PTSD-D.”

For related information, see the Psychiatric News article “Researchers Tackle Complexity of Intergenerational Stress Transmission.”

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APA Paper Describes How Psychiatrists Can Improve Health of SMI Patients

Psychiatrists should routinely screen patients with serious mental illness (SMI) for common medical conditions, counsel them on lifestyle modifications to reduce cardiovascular risk factors, and coordinate with their primary care physicians to narrow the longevity gap between this group and the general population. These were some of the conclusions in a white paper that APA issued yesterday at a Capitol Hill briefing.

More than a decade has passed since researchers found that people with SMI treated in the public mental health system are dying on average 25 years earlier than the general population. “The majority of these deaths are due to untreated medical issues,” said Saul Levin M.D., M.P.A., APA CEO and medical director. “However, little progress has been made in rectifying this disparity.”

While patients with SMI often suffer from economic disadvantage and chronic stress caused by their illness, modifiable risk factors play a role as well that psychiatrists can readily address. Patients with SMI are more likely than the general population to use tobacco or other substances, have a poor diet, lead a sedentary lifestyle, and not comply with treatment regimens. These factors, coupled with the propensity for psychotropic medications to cause obesity and metabolic disorders, all contribute to the early mortality of patients with SMI. “But treatment is possible, and treatment does work,” Levin said.

Medical professionals’ bias against and stereotyping of SMI patients, particularly in the emergency department (ED), can also imperil the lives of these patients, said Glenda Wrenn, M.D. (above), director of the Kennedy-Satcher Center for Mental Health Equity at Morehouse School of Medicine in Atlanta. In fact, ED physicians list dealing with psychiatric patients as their “chief complaint” about doing their job, she said. She has seen cases in which patients with SMI died of delirium tremens because ED physicians failed to catch acute alcohol withdrawal.

Medical training for psychiatrists is often limited to medical school and a few months of internship, pointed out Benjamin G. Druss, M.D., the Rosalynn Carter Chair in Mental Health at Emory University. To keep their skills up to date, training in outpatient medical care should be provided to practicing psychiatrists in continuing medical education programs and cross-training opportunities with other medical service providers.

Ultimately, the white paper calls for more research on which models of care would best lead to the improvement of SMI patients’ physical health as well as determine the optimal role of psychiatrists in these models.

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ABPN to Pilot New Test Format as Alternative to 10-Year Proctored MOC Exam

The American Board of Psychiatry and Neurology (ABPN) is piloting a new open-book, journal article–based assessment beginning in 2019 as an alternative to the proctored 10-year Maintenance of Certification (MOC) examination.

Eligible diplomates who choose to participate in this pilot program will be required to read and answer questions on between 30 and 40 journal articles. Diplomates may choose from a library of articles that have been selected for the test by the ABPN Pilot Project Test Writing Committees. The pilot project will run for three years, from 2019-2021. If approved by the American Board of Medical Specialties (ABMS), the ABPN plans to transition diplomates into this program in 2022 as a permanent alternative to the secure MOC examination. Staff at ABPN say emailed invitations to the new testing option will be delivered next week.

Diplomates who are eligible to participate in the pilot program are those who are currently certified and who fall into one of two categories: those who have earned ABPN certification or who passed the MOC examination in the years 2012, 2013, or 2014 in psychiatry, child and adolescent psychiatry, neurology, or child neurology; or those whose certificate is expiring in 2019, 2020, or 2021 in psychiatry, child and adolescent psychiatry, neurology, or child neurology.

APA leaders said that the article-based, open-book test option is an important step in making MOC more flexible.

“Requirements around Maintenance of Certification are among the most prominent concerns of our members, and many have been asking for an alternative to the 10-year, secure, proctored exam,” APA President Anita Everett, M.D., told Psychiatric News. “APA has been advocating for something similar to the open-book journal article–based assessment, and we hope it provides an attractive option for members to consider.”

APA CEO and Medical Director Saul Levin, M.D., said the new program “provides more flexibility in terms of diplomates being able to select articles that are relevant to their own practice. It allows diplomates to read the articles and complete the test at their own pace.”

More information about the new test option will appear in an upcoming edition of Psychiatric News. Information on the program is also available on the ABPN website.

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Adjunctive Ketamine Appears to Reduce Suicidal Thoughts in Depressed Patients for Up to Six Weeks

A single adjunctive infusion of ketamine appears to reduce suicidal thoughts in depressed patients within 24 hours, according to a study published yesterday in AJP in Advance. This improvement was maintained for six weeks with standard, optimized pharmacotherapy.

While previous studies have suggested ketamine rapidly reduces suicidal ideation in some patients, whether similar effects would be seen in patients with major depression and high levels of suicidal ideation was less clear.

Researchers from Columbia University Medical Center and the New York State Psychiatric Institute randomly assigned 80 adults with major depressive disorder and suicidal ideation to receive ketamine or midazolam infusion. At baseline, 54% of the sample was taking antidepressant medication.

The researchers assessed the study participants’ suicidal ideation at the start of the trial using the clinician-rated Scale for Suicidal Ideation (SSI). The SSI consists of 19 items, including severity of wish to die, passive and active suicide attempts, and duration and frequency of ideation, which can be used to monitor a patient's response to interventions. This assessment was repeated 24 hours before infusion with ketamine or midazolam, 230 minutes after infusion, 24 hours after infusion, and at weeks one to six after infusion. Patients were also asked about symptoms of depression and anxiety before and after the infusion, as well as adverse effects following the infusion and again at six-week follow-up.

Within 24 hours of patients’ having received intravenous ketamine (0.5 mg/kg in 100 mL saline) or midazolam (0.02 mg/kg in 100 mL saline) infused over 40 minutes, patients in the ketamine group experienced a greater reduction in SSI score than that of the midazolam group. The proportion of patients who experienced a reduction ≥50% in their SSI score 24 hours after receiving an infusion was 55% for the ketamine group and 30% for the midazolam group. The ketamine group also experienced greater reductions in overall mood disturbance, depression, and fatigue, as measured by the Profile of Mood States, within 24 hours compared with the midazolam group.

“Longitudinal analysis of the uncontrolled six-week follow-up showed that clinical improvement after randomized and open ketamine treatment was generally maintained through six weeks of open, optimized clinical follow-up treatment with respect to SSI score and depression ratings,” Michael F. Grunebaum, M.D., and colleagues wrote.

Patients in the ketamine group experienced an increase in blood pressure and dissociative symptoms compared with patients in the midazolam group, but these adverse effects typically resolved within minutes to hours following the infusion.

“Given concerns about ketamine’s one- to two-week antidepressant effect in previous studies, it is notable that the improvement in suicidal ideation in this trial was largely maintained through the six-week follow-up ratings,” the researchers wrote. “This may be partly explained by the fact that patients continued prior psychotropic medication, which was optimized after completion of day 1 postinfusion ratings.”

For related information, see the Psychiatric News article “Analysis Finds Single-Dose Ketamine Effective for Suicidal Ideation.”

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New Geriatric Cognition Chart May Improve Dementia Monitoring

Researchers at Laval University in Quebec and colleagues have devised an assessment chart called QuoCo (for cognitive quotient) to track patient cognition, offering a new method they say can help identify dementia during the earliest stages. The study was published yesterday in the Canadian Medical Association Journal.

“Similar to the ‘growth charts’ that are used in pediatrics, cognitive charts allow physicians to position any patient based on age, education, and Mini-Mental State Examination [MMSE] scores, and simply track the longitudinal profile of cognitive decline over time,” wrote lead study author Patrick Bernier, M.D., Ph.D., and colleagues. Such a chart “could prompt earlier intervention for an older adult who ‘fell off’ the curve,” the authors noted.

The MMSE is commonly used to screen for dementia, but there is no consensus on how best to determine whether changes in MMSE scores over time reflect age-associated cognitive decline or represent mild cognitive impairment or dementia. Also, previous studies show MMSE cut-off scores are less reliable for some populations, particularly for older adults with less formal education.

Bernier and colleagues analyzed data from a longitudinal study of older adults known as the Canadian Study of Health and Aging. They assessed 7,569 participants aged 65 years or older who completed an MMSE at study baseline, and then 5 and 10 years later.

By comparing score results of the 6,411 participants who remained cognitively healthy during the follow-up with the 1,158 who developed dementia, while controlling for age and education, the investigators developed QuoCo scores. Similar to charts used to monitor infant growth, the researchers developed a chart that reflected optimal rates of gradual cognitive decline with age, divided into five broad percentile zones. Any patient who dropped by more than one percentile zone on the QuoCo following their initial visit was classified as having dementia.

Bernier and colleagues found that the model could distinguish healthy participants from those with dementia with a specificity of 89% and a sensitivity of 80%. The QuoCo was about 12% better overall than only using an MMSE score of 24 or less as a dementia cutoff; however, while using the cognitive charts improved the classification of patients with dementia, it also increased the misclassification of some patients with normal cognition.

To read more on this topic, see the Psychiatric News article “Dual-Task Gait Testing Identifies MCI Patients Likely to Develop Dementia.”

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Long-Term SSRI Treatment May Delay Progression From Mild Cognitive Impairment to Alzheimer’s Dementia

Long-term treatment with selective serotonin reuptake inhibitors (SSRIs) may benefit elderly patients with mild cognitive impairment (MCI) and a history of depression, even after depressive symptoms have resolved, suggested a study published in AJP in Advance.

In patients with MCI and a history of depression, long-term treatment with SSRIs (for more than four years) was associated with a delayed progression to Alzheimer’s dementia by about three years, compared with those who used SSRIs only short term or who had no treatment.

Delaying the progression from MCI to Alzheimer’s dementia would not only reduce the prevalence of Alzheimer’s disease, but also cut health insurance costs, wrote Claudia Bartels, Ph.D., of the University of Medical Center Gottingen, in Germany, and colleagues.

Bartels and colleagues analyzed data on 755 nondepressed adults aged 55 to 90 who were culled from the multicenter Alzheimer’s Disease Neuroimaging Initiative (ADNI). Participants were categorized at baseline as cognitively normal control subjects, patients with MCI, and patients with Alzheimer’s dementia and were comprehensively reassessed every six months or annually for progression from cognitively normal to MCI or Alzheimer’s dementia, or from MCI to Alzheimer’s dementia.

Of the 755 participants in the analysis, 532 were allocated at baseline to the “no history of depression–no antidepressants” group and 223 to the “history of depression” group. Of the latter group, 60 were untreated (prior depression–no antidepressants), 116 had received SSRIs (prior depression–SSRI), and 47 had received antidepressants other than SSRIs (prior depression–other antidepressants).

Statistical analysis revealed “a significantly decreased probability of conversion to Alzheimer’s dementia in MCI patients with a history of depression and long-term SSRI treatment [>1,610 days] compared with all other groups,” the authors reported. “The risk of conversion was increased in MCI patients with a history of depression and other antidepressant treatment compared with the no prior depression–no antidepressants group.” After three years of observation, however, the advantage of long-term SSRI treatment in previously depressed patients “dissolved,” researchers noted, and all groups had similar rates of progression from MCI to Alzheimer’s dementia.

The authors concluded, “Pending validation in an intervention trial, the data produced in this study may have important implications for clinical practice. … A prospective study to confirm SSRI effects on MCI progression is now warranted, as an SSRI-mediated delay may contribute to an overall lower prevalence of Alzheimer’s dementia, with a major impact on affected individuals, caregivers, public health, and health costs.”

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FDA Approves First Once-Monthly Injectable Buprenorphine for Opioid Use Disorder

The Food and Drug Administration (FDA) has approved Sublocade, the first once-monthly injectable buprenorphine product for the treatment of moderate-to-severe opioid use disorder (OUD) in adults who have initiated treatment with a transmucosal (absorbed through mucus membrane) buprenorphine-containing product. Sublocade is indicated for patients who have been on a stable dose of buprenorphine treatment for a minimum of seven days and is meant to be used as part of a complete treatment program that includes counseling and psychosocial support.

“Sublocade provides a new treatment option for patients in recovery who may value the benefits of a once-monthly injection compared to other forms of buprenorphine,” the FDA stated in a press release.

The FDA approval of Sublocade was based in part on the results of two clinical studies of 848 adults who had a diagnosis of moderate-to-severe OUD and began treatment with buprenorphine/naloxone sublingual film (absorbed under the tongue). Sublocade provided sustained therapeutic plasma levels of buprenorphine over the one-month dosing interval, according to Indivior Inc., manufacturer of the medication.

In a 24-week phase 3 trial, researchers randomized patients to one of the following three regimens: six once-monthly Sublocade 300 mg doses; two once-monthly Sublocade 300 mg doses followed by four once-monthly 100 mg doses; or six once-monthly injections of placebo. According to Indivior, both dosage regimens of Sublocade were shown to be superior to placebo in achieving more illicit opioid-free weeks.

“The FDA is requiring postmarketing studies to assess which patients would benefit from a higher dosing regimen, to determine whether Sublocade can be safely initiated without a dose-stabilization period of sublingual buprenorphine, to assess the feasibility of administering Sublocade at a longer interdose interval than once monthly, and to determine a process for transitioning patients with long-term stability on a transmucosal buprenorphine dose to a monthly dose of Sublocade without the use of a higher dose for the first two months of treatment (loading dose),” the agency’s press release stated.

The most common side effects of Sublocade include constipation, nausea, vomiting, headache, drowsiness, injection site pain, itching (pruritus) at the injection site, and abnormal liver function tests. The safety and efficacy of Sublocade have not been established in children or adolescents under 17 years of age or adults over age of 65.

Sublocade features a boxed warning that notes the dangers of administering the drug intravenously instead of subcutaneously: “Sublocade forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including threatening pulmonary emboli, if administered intravenously.”

The medication must be prescribed and dispensed as part of a Risk Evaluation and Mitigation Strategy to ensure that the product is not distributed directly to patients, the FDA noted.