is Clinical Professor and Chair of Psychiatry and Behavioral Science at the University of North Dakota School of Medicine and Health Sciences.

This past year has been one of significant disruption to our environments (natural, social, economic, and other). Many individuals rely on cultural connections as a way of finding meaning. Most cultures have creation stories which help to make sense of our being in the world; and many such stories include a reconnection with the divine. The Lurianic account of creation references a cosmological reparation, “Tikkun Olam,” through the gathering of light and souls. In recent times, this term has come to be associated with social responsibility for repairing our world. It is such a story that inspired the following poem:

Articles

Words—an excellent reflection of the soul. 

Soul

As this issue went to press, the Centers for Disease Control and Prevention reported that about 

 had received at least 1 dose of the COVID-19 vaccine. Despite new variants and continued behavioral challenges worldwide, the progress made in addressing the pandemic is enormous, reminding us that we can—and should—do better in other areas of medicine, health care, and societal issues.

. While the opioid epidemic raged through the country and caught the attention of doctors, lawmakers, and others, the methamphetamine epidemic lurked in the shadows. This problem received less consideration even though, as 

, discusses in the lead article, the 2 drugs are often used concurrently. Great strides have been made toward understanding and addressing the opioid epidemic; hopefully, in the future, we will report the same for methamphetamine.

Cynthia M. A. Geppert, MD, MA, MPH, MSBE, DPS, MSJ

, reflects on the progress of the COVID-19 vaccine distribution but asks, “What about us?” In her commentary, Geppert ponders parity and whether patients with serious mental illness and substance use disorders (as well as the psychiatrists caring for them) were properly prioritized in the receipt of the vaccines. In doing so, she renews the call for advocacy for patients with mental illness to improve care now and in the future.

 on sexual and gender minority youth, a population facing increased challenges and at risk of mental health issues. With thanks to Special Report Chair Jack Turban, MD, this collection of articles shines a light on a population for whom the health care system can do better. As Turban explains, psychiatrists are in a unique position to foster positive affirmations for youth, both as a part of clinical care and as educators in the community.

™ features clinical pieces with practical guidance for supporting the patients in your care. This month’s Research Update looks at the pharmacotherapies that are most effective for schizoaffective disorder. Meanwhile, 2 articles explore the impact of psychiatric illness on the whole patient and provide suggestions to protect their well-being. 

, explores lithium dosing in renal patients, and Lawson Wulsin, MD, and Juliana Zambrano, MD, discuss treatment dilemmas in patients with comorbid depression and coronary heart disease.

As we have learned from our tango with COVID-19, there is no challenge we cannot overcome when we work together to find and implement solutions. Our country and the field of psychiatry continue to face these and other difficult issues. Yet, with continued dedication on behalf of all of you, we are sure to realize more successes and positive outcomes in the days, months, and years to come! ❒

Chairman and Founder, MJH Life Sciences™

An introduction to the May issue of Psychiatric Times.

Tackling the Big Issues

Psychiatry may be lagging behind other branches of medicine in an important way.

“In the rest of medicine, as you increase the acuity you increase the number of treatments,” Nolan Williams, MD, told the attendees of the 2021 American Psychiatric Association (APA) Annual Meeting, but in psychiatry, “as we increase acuity we actually lose treatment options.”

Williams and his fellow presenters at a panel on rapidly acting medications

 all had the same question: How can psychiatrists design treatments to respond to sudden-onset conditions?

Williams, assistant professor of psychiatry and behavioral sciences at Stanford University Medical Center, described the situation as “emergency room purgatory.” Because of slow-acting treatments and limited hospital capacity, “the whole process of going through the inpatient unit can take several months,” he said. “The only treatment that we have available for these folks is ECT [electroconvulsive therapy.” But ECT is available in only 10% of US hospitals.

However, psychiatrists might have other options for fast-acting treatments. He shared 

showing that accelerated theta burst repetitive transcranial magnetic stimulation (r-TMS) had positive results for mood disorders, including MDD.

 R-TMS treatment works by stimulating the left dorsolateral prefrontal cortex (DLPFC). In MDD, the DLPFC may be failing to inhibit the subgenual cingulate, and the result of this network failure is cognitive impairment and inwardly directed negative thoughts,” Nolan explained. “By stimulating DLPFC, r-TMS corrects the mood imbalance and restores mood regulation.”

In initial numbers from his study of patients with a treatment-resistant mood disorder (TRD), Nolan found that after 5 days of sessions (10 hourly sessions at 1800 theta-burst pulses per hour), participants improved. On the Montgomery Asberg Depression Rating Scale (MADRS), he found an 80% average reduction of participants MADRS scores.

Another options for fast-acting treatment is ketamine. Charles DeBattista, MD, professor of psychiatry and behavioral sciences at Stanford University, presented evidence for its efficacy for TRD. He noted that ketamine is an anesthetic agent, a μ-opioid agonist, and while its effects on TRD are rapid, making it potentially helpful in psychiatric emergencies. “Often within a couple of hours to a day, patients experience a significant improvement, and the effects were sustained for a week or so,” he said. These effects did decrease after a week, but there is also evidence that repeated injections may lead to 

DeBattista also presented the option of esketamine, which has been fast tracked by the US Food and Drug Administration for treating TRD and acute suicidality in MDD. Multiple studies have found that it rapidly 

New mothers represent another population that might benefit from fast-acting medications. “Maternal mental health is something that’s been an enormous problem forever,” said Samantha Meltzer-Brody, MD, MPH. “Those of us that have the privilege of working with perinatal women are always struck by how debilitating PPD [postpartum depression] can be.” Rapidly acting medications could reduce mortality and morbidity, she said, and allow for more positive interactions between mothers and their newborns.

Although many selective serotonin reuptake inhibitors are approved to treat PPD, she pointed out that their initial effects may not be felt for weeks or even months, and many women’s symptoms do not respond to them. Meltzer-Brody, the Assad Meymandi Distinguished Professor and Chair in the University of North Carolina Department of Psychiatry, also considers an alternative to these medications: neurosteroids like brexanolone.

In a 2018 paper, Meltzer-Brody and her coauthors found brexanolone to be effective for

 Using the HDRS for measurement, the researchers found an average 8- to 10-point reduction in 12 hours, and around an 18-point reduction at 60 hours, the study’s primary endpoint. At day 30, participants average reduction remained, on average, 16 points down from baseline. The paper hypothesized that brexanolone works by increasing γ-aminobutyric acid (GABA) function, which appears to be inhibited during PPD.

With these new options, it seems psychiatry may not lag behind other branches of medicine for long. 

1. Williams N. Developing rapidly acting antidepressants: neurosteroids, dissociative agents (Ketamine Analogues and Psilocybin), and Accelerated Theta Burst r-TMS. Paper presented at: American Psychiatric Association Annual Meeting; May 1-3, 2021; virtual.

2. Nettekoven C, Volz LJ, Kutscha M, et al. Dose-dependent effects of theta burst rTMS on cortical excitability and resting-state connectivity of the human motor system. 

3. Li CT, Chen MH, Juan CH, et al. Efficacy of prefrontal theta-burst stimulation in refractory depression: a randomized sham-controlled study. 

4. Yip AG, George MS, Tendler A, et al. 61% of unmedicated treatment resistant depression patients who did not respond to acute TMS treatment responded after four weeks of twice weekly deep TMS in the Brainsway pivotal trial. 

5. Murrough JW, Perez AM, Pillemer S, et al. Rapid and longer-term antidepressant effects of repeated ketamine infusions in treatment-resistant major depression. 

6. Canuso CM, Singh JB, Fedgchin M, et al. Efficacy and safety of intranasal esketamine for the rapid reduction of symptoms of depression and suicidality in patients at imminent risk for suicide: results of a double-blind, randomized, placebo-controlled study. 

7. Fu DJ, Ionescu DF, Li X, et al. Esketamine nasal spray for rapid reduction of major depressive disorder symptoms in patients who have active suicidal ideation with intent: double-blind, randomized study (ASPIRE I). 

8. Meltzer-Brody S, Colquhoun H, Riesenberg R, et al. Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials. 

What treatments could handle both psychiatric emergencies and long-standings mental health conditions—in a hurry?  

Fast-Acting Options for Mood Disorders and Psychiatric Emergencies

Susan J. Noonan, MD, MPH, talks about the way mood disorders can disrupt a patient's life, as they are chronic and often do not respond readily to treatment. 

is a physician consultant and Certified Peer Specialist in the Department of Psychiatry at McLean Hospital and the Massachusetts General Hospital. She is the author of four books and a blog on managing depression, most recently 

Helping Others With Depression: Words to Say, Things to Do (December 2020)

. Dr Noonan offers peer counseling to fellow patients, including physicians and other professionals, and can be confidentially reached through her website at 

Videos

What can be done when a mood disorder upends a patient's life?

A Life Interrupted: Impact of Mood Disorders

John J. Miller, MD, guides us through a meditation session. 

is medical director, Brain Health, Exeter, NH; editor in chief,

; staff psychiatrist, Seacoast Mental Health Center, Exeter, NH; consulting psychiatrist, Exeter Hospital, Exeter, NH; consulting psychiatrist, Insight Meditation Society, Barre, MA.

Guided Free Attention Meditation

Too often, the medical issues associated with traumatic brain injury are mistaken as psychiatric disorders, and patients are referred to psychiatrists for treatment, Gregory J. O’Shanick, MD, DLFAPA, told attendees of the 2021 

American Psychiatric Association Virtual Annual Meeting

O’Shanick, who is the medical director of the 

in Richmond, Virginia, urged psychiatrists to leverage their medical knowledge when assessing patients to determine when the diagnosis is a psychiatric disorder and when patients are presenting with medical mimics associated with traumatic brain injury (TBI). He shared his frustration with psychiatry’s loss of medical identity, especially as it related to brain injury medicine. In his 40-year career, he found “all too often, physicians, both MDs and DOs, psychiatrists, [were] missing basic neurologic issues that we as physicians should catch. If we are to be vocal regarding the necessity of having a MD and DO to ultimately provide oversight of care for those with behavioral disorders and writing prescriptions for psychotropic medications, we must not relinquish the use of those tools and skills that were taught to us in medical school.”

The prevalence of TBI has increased over the last 10 or so years, O’Shanick explained, although he acknowledged that the increase may be partially due to increased awareness. According to 

 from the Centers for Disease Control and Prevention, there was a 53% increase from 2006 to 2014 in TBI-related emergency department visits, hospitalizations, and deaths. In older adults and the very young, falls account for the number 1 cause of TBI.

 A combination of motor vehicle accidents, sports, falls, and other activities were the cause for the “very active” and maybe not as cautious young adult population (aged 15 years to 24 years).

Meanwhile, research has found a link between psychiatric disorders and TBI, O’Shanick noted, with an increase of disorders following TBI.

 Jennie Ponsford, PhD, and colleagues explored this phenomenon and found that only about 23% and 21% of individuals had a pre-TBI history of a mood disorder or anxiety disorder, respectively. They found an increase in psychiatric symptomology within the first year after TBI, with a stabilization at the 5-year point. Mood and anxiety symptoms were most common in patients with TBI, with 17.2% to 62% presenting with mood symptoms and 10.3% to 34.2% with anxiety symptoms. Interestingly, he noted depression is 4 to 6 times more common in patients with TBI than the general population, and is the most common cause of depression in men (as opposed to women, for whom menopause is the number one cause).

It is possible, he explained, that some of these mood disturbances and anxiety symptoms may be better explained as a medical consequence of TBI—or a signal of homeostatic disruption. In such cases, providing psychopharmacological treatment might help the patient with the symptoms, but will not address the underlying cause.

O’Shanick provided an example of a phobia being misattributed. He pointed to an individual who is afraid of a jumping off a diving board. They go up the stairs, walk to the edge, realize they are frightened, and go back down. They have conditioned themselves to be afraid—there is a learned component.

Next, he presented the case of an individual who has unrecognized balance and visual issues as a result of TBI. The person goes into a crowd and feels a sense of anxiety, because they have trouble feeling and remaining stable, and the learned component may be inappropriately linked to an anxiety disorder.

“As a physician, we need to figure that out,” O’Shanick emphasized.

Fortunately, a toolkit to help decipher these TBI-related medical mimics is relatively inexpensive, O’Shanick shared. All you need is a pen, index card, blindfold (or ask your patient to close their eyes), a sofa cushion, a tuning fork (which can be procured online for about $6), and a few questions. For example, to determine if the issue is 

 or a vestibular in nature, ask your patient if they need to touch the wall when closing their eyes in the shower to prevent falling. Or, if they feel anxious in a crowded area like a store or mall, does pushing a cart or stroller or holding on to someone make them feel better? If so, there are a few simple follow-up tests (eg, the Balance Error Scoring System and Fukuda Stepping Test) to help confirm the medical mimic. A referral for vestibular physical therapy and a neuro-ENT may prove useful for such patients.

Similarly, to determine if there is social phobia or vergence, ask your patient if they are having trouble seeing/reading books at a normal distance. Then, check near point convergence and conduct a cover test. A referral to a neuro-optometrist should be considered.

Sometimes a central auditory processing disorder may be confused with 

. It is especially important to decipher the difference, O’Shanick explained, because stimulants will worsen the central auditory processing disorder. Ask your patient if they have better sustained attention for visual vs verbal interactions, or if they have trouble understanding what people say if they cannot see their faces or mouths. Weber and Rinne tests can also prove useful, and a referral to an audiologist is indicated.

, posttraumatic neuroendocrine (PTNE) disorders may be relatively common in patients with TBI,

 and mood symptoms are associated with PTNE, O’Shanick explained. Psychiatrists should inquire about changes in menses, sex drive, cold intolerance, and skin and hair dryness to elucidate if PTNE is a potential cause of the mood symptoms. Lab studies should be considered, including 

, TSH, FSH, LH, IG-1, estradiol/testosterone, and am/pm cortisol. In considering TBI in these cases, O’Shanick reminded attendees that they should not overlook 

Finally, O’Shanick illuminated inherent biases in the Minnesota Multiphasic Personality Inventory-2, which might lead to an incorrect diagnosis. For instance, stomach trouble and headaches score positively on the hypochondriasis scale, but both may be related to TBI and TBI treatments. Similarly, positive scores on the hysteria scale result from noting they are unable to work, feel sad, and have trouble sleeping, all of which are associated with TBI.

Ultimately, the psychiatrist is the ideal position to leverage their medical and behavioral knowledge to support these patients.

“Hopefully this will allow you to think a little bit differently when patients come into your office,” O’Shannick concluded. “Maybe ask some increased questions when it comes to injury related issues, concussion related issues… and to see if there is some other types of medical issues behind some of the anxieties that your patients have. At the end, you may just find that you’re practicing … much more successfully and ultimately helping your patients.”

1. CDC. Surveillance report of traumatic brain injury-related emergency department visits, hospitalizations, and deaths. 2014. Accessed May 2, 2021. 

https://www.cdc.gov/traumaticbraininjury/pdf/TBI-Surveillance-Report-FINAL_508.pdf

2. Ponsford J, Always Y, Gould KR. Epidemiology and natural history of psychiatric disorders after TBI. 

3. Beyer C, Zaytsev J, Donegan D, et al. 

The effects of traumatic brain injury on pituitary function: a systematic review and meta-analysis

Too often, the medical issues associated with traumatic brain injury are mistakenly diagnosed as psychiatric disorders. A few simple questions and tests can elucidate the real culprit and lead to appropriate treatment.

Is It a Psychiatric Disorder or TBI Medical Mimic?

“There simply aren’t enough of us,” said Lori Raney, MD, in a scientific session, titled “

Unprecedented Access to Psychiatry: Expand Your Impact to Infinity and Beyond! Collaborative Care, eConsults, and ECHO Models

American Psychiatric Association (APA) Annual Meeting

. The session addressed the vast shortage of psychiatrists and proposed alternative models of care to improve outcomes for more patients.

Speakers discussed the ever-widening gap between the shortage of psychiatrists and the overflowing flood of patients needing care. Shannon Kinnan, MD, a member of the APA Integrated Care Committee, spoke about the gravity of the problem of access to psychiatry. “The severity and the incidence of psychiatric illness continues to climb, which has only been magnified by the pandemic,” said Kinnan, assistant professor at Creighton University School of Medicine, Omaha, Nebraska. She worked in psychiatric services that had a wait list of 350 patients.

Moderated by Ron M. Winchel, MD, assistant clinical professor at Columbia University School of Medicine, Department of Psychiatry, presentations centered around 4 main themes: collaborative/integrated care, psychiatric consults, ECHO models, and eConsults.

Collaborative care, also known as integrated care, is ever evolving, informed by decades of research conducted by the APA, Academy of Psychosomatic Medicine, and other organizations. Kinnan directed participants to APA’s 

 to explore current evidence-base for the model, elements of implementation with detailed examples, lessons learned by those in the trenches, as well as recommendations on how to advance the use of the collaborative care model.

According to Kinnan, the collaborative care model is made up of a patient-centered team that targets the special needs of each patient, looks for solutions, and lays out piece by piece ways to educate primary care physicians (PCP). One core feature of the collaborative model includes encouraging PCPs to use measurement-based care with tools such as Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7).

“The patient’s main points of contact are their PCP and a care manager,” she explained. “The psychiatric consultant then reviews cases in a registry with a care manager and offer guidance to the team on the case.”

The integrated psychiatry model attends to the needs of patients with team-based care and systematic regular caseload reviews, which involves psychiatrists, case managers, PCPs, social workers, and other health care providers. It enables delivery of services to patients at most dire need of psychiatric services.

“It is better than traditional care in the primary care setting,” Kinnan told attendees. “Patients get better, faster. And there’s cost savings as well.”

A consult enables those involved in behavioral health to manage multiple cases and communicate with different allied health professionals, with the goal of extending psychiatric services.

According to Lori Raney, MD, a practicing psychiatrist in Colorado and principal consultant with Health Management Associates, curbside consultation educates PCPs about diagnostic dilemmas and medications, helping them with complex patients.

A consult is an opportunity for psychiatrists to educate and collaborate with the general practitioner, especially important since medical training often involves only 2 weeks of psychiatric training. The consult enables the PCP to understand specific needs of patients and provides diagnostic clarification.

“There are definite approaches you can take,” Raney told attendees. “You want to build the PCP’s confidence in prescribing psychotropic medications and diagnosing behavioral health conditions.”

Psychiatrists can get calls for consults on a variety of issues, Raney explained. “The most prevalent, most common behavioral health conditions we are getting called about often involve anxiety disorders, depression, and substance use disorders . . . And then you’ll see other things, patients with multiple somatic symptom personality disorder traits and pain that play out in the clinic,” said Raney.

Another item on the menu of integrated behavioral health is the electronic mental health consultation (eConsult).

Christopher T. Benetez, MD, associate medical director of the Los Angeles County Department of Mental Health and assistant clinical professor at UCLA David Geffen School of Medicine, has conducted more than 5000 eConsults in the LA County project over the past 5 years.

“An eConsult is an asynchronous consultative, provider-to-provider communication within a shared electronic health record [EHR] or web-based program,” Benetez explained.

The eConsult approach enables PCPs to have remote access to psychiatrists, entering questions into an EHR for quicker response than the bottleneck often found in traditional models of care.

As the second largest health system, LA County occupies more than 4000 square miles with 10.5 million residents, and it is both rural and urban. Psychiatrists are also involved in an array of community partnerships, jails, and courts.

The eConsult in LA County and other community health hubs are intended for the Safety Net population, defined by the Institute of Medicine (IOM) as “those providers that organize and deliver a significant level of health care and other needed services to uninsured, Medicaid and other vulnerable patients.”1

The eConsult system has optimized health equity by filtering psychiatric expertise to geographically challenged regions and a greater number of residents. “Our Safety Net takes care of over half a million patients a year with > 400 distinct sites; 4000 submitters; 500 specialty reviewers; and > 65 specialty portals,” said Benetez.

The advantages of the system set in place is centralized and coordinated systems and greater access to routine care, as well as patient-centered care and patient education. Limitations include measuring data, reimbursement, and concerns over liability.

Another way to improve access to psychiatric expertise has been through a learning community. Mark Duncan, MD, spoke about one alternative model at the University of Washington (UW).

Duncan is assistant professor at the Department of Psychiatry and director, UW Psychiatry and Addictions Case Conference (UW PACC), a 

 initiative. ECHO stands for Extension for Community Healthcare Outcomes.

 is made up of a didactic and case presentations. “The goal is to increase patient access across the state to effective and evidence based psychiatric, psychological, and addiction care through increasing the knowledge and self-efficacy of all interested health providers within an intentionally supportive virtual community,” said Duncan.

Using a collaborative/educational model, UW PACC is in a position to help guide care across disciplines, including psychology, psychiatry, and primary care. The net result has been to help change practice, build community, and identify providers needing the most assistance.

“It’s a great service because we’re interacting with the provider and asking for quick follow-up questions across many other specialties, so we can get a well-rounded summary of recommendations for people.”

America’s Health Care Safety Net: Intact But Endangered.

 Washington, DC: National Academy Press; 2000.

Collaborative care guides care across disciplines, including psychology, psychiatry, and primary care. The goal is to change practice, build community, and identify health professionals needing the most assistance.

Serving the Needs of the Many: Identifying Strategies for Better Care

“The current opioid crisis has been responsible for the largest increase in deaths associate with opioids that we have ever known,” said Nora D. Volkow, MD, at the 2021 Virtual American Psychiatric Association Annual Meeting.

Volkow, Director of the National Institute on Drug Abuse (NIDA) at the National Institutes of Health, discussed how the pandemic has exacerbated the opioid crisis in the session, “

Collision of the Opioid Crisis and the COVID-19 Pandemic.”

In March 2020 during the outset of the pandemic, the number of people reporting drug use rose significantly.

 The top 4 drugs were nonprescribed fentanyl, cocaine, heroin, and methamphetamine. Overdoses increased up to 42% per month during the pandemic.

 If an individual had SUD and were infected with SARS-CoV-2, the likelihood of dying increased, especially for black men.

As the amount of drug use increased, so did the problems. The pandemic presented a number of key challenges for individuals with substance use disorder (SUD), Volkow noted, including: stigma, isolation, and loss of work/homes. These challenges prevented individuals with SUD from getting proper care, or worsened their condition. Volkow gave an overview of these issues and their impacts.

“We know that people with opioid use disorder… are terribly stigmatized,” Volkow stated. “It’s very hard sometimes to convince people with an opioid use disorder to go to a hospital because they don’t like to be discriminated against or mistreated.”

Stigma and the belief they will not receive thoughtful care already kept some individuals with SUD from checking into a hospital; the pandemic worsened this likelihood. Both hospitals and prisons became hotbeds for the SARS-CoV-2 virus, places often with higher concentrations of individuals with SUD.

“In order to reverse an overdose, someone has to give them naloxone,” Volkow said. “But if you are isolated, and start shooting by yourself, the likelihood of getting naloxone is much less likely.”

According to Volkow, reports from the community suggest an increased number of overdose deaths in homes where the individual was alone.

“Economic challenges are some of the stress source that leads people to take more drugs to try to cope,” Volkow relayed.

Homelessness was also associated with an increased likelihood of contracting the SARS-CoV-2 virus, due to social distancing problems.

Volkow wants to increase research on topics like telemedicine and changes in the justice system, and how they can be furthered post-pandemic. Expanding access to treatment of comorbid conditions via telemedicine, and releasing nonviolent inmates with SUD, are just a few ideas she has.

Volkow posed the following question for the audience to ponder: “What is the structure we need to provide for these individuals to be successful in adjusting to their community and not be at risk for relapse?”

1. Millennium Health. Signals report COVID-19 special edition. July 8, 2020. 

https://www.millenniumhealth.com/news/signalsreportcovid/

2. Overdose Detection Mapping Application Program. 

3. Wang QQ, Kaelber DC, Xu R, Volkow ND. COVID-19 risk and outcomes in patients with substance use disorders: analyses from electronic health records in the United States. 

According to Nora D. Volkow, MD, Director of the National Institute on Drug Abuse, drug use and overdose deaths have significantly increased since the outset of the pandemic. What made it worse?  

A Tale of Two Crises: Fighting the Overdose Problem During the Pandemic 

Sunovion Pharmaceuticals presented data on the late-stage pipeline candidate SEP-363856, a trace amine-associated receptor 1 (TAAR1) agonist with serotonin 5-HT

 agonist activity under investigation for the treatment of schizophrenia at the 2021 American Psychiatric Association Virtual Annual Meeting.

“The SEP-363856 safety analysis presented at APA supports previous clinical trial evidence that this agent is associated with a differentiated side effect profile compared to currently approved atypical antipsychotics. These data further support the characterization of SEP-363856 as representing a new class of medicines for the treatment of schizophrenia,” Armin Szegedi, MD, PhD, Senior Vice President and Chief Medical Officer of Sunovion, said to the press. “We are pleased to discuss these SEP-363856 data with the clinical community to foster further understanding of this novel compound.”

SEP-363856 was highlighted in the poster titled “The Safety Profile of the TAAR1 Agonist, SEP-363856, is Distinct From Atypical Antipsychotics,” (poster P12-007). The poster covered data analysis from the US Food and Drug Administration’s (FDA) real-world adverse event reporting database (FAERS), and compared the frequency of adverse events (AEs) related to antipsychotic schizophrenia treatment occurring in 11 atypical antipsychotics to those in observed with SEP-363856 in clinical studies.

The analysis found the cumulative rate and patterns of AEs was distinctly different for SEP-363856 than for atypical antipsychotics.

The presentation “Effects of SEP-363856, a Novel TAAR1 Agonist, on Negative Symptoms in Schizophrenia: Results Across an Initial Double-Blind Acute Study and a 6-Month, Open-Label Extension Study,” (poster P11-086), also highlighted the pipeline candidate. It demonstrated that short-term treatment with SEP-363856 saw improvement in negative symptoms of schizophrenia when compared to placebo. Long-term treatment also saw additional mean improvement in the Brief Negative Symptom Scale (BNSS) total score and BNSS factor scores.

1. Sunovion. Sunovion presents data from marketed and late-stage development psychiatric compounds at the American Psychiatric Association (APA) Annual Meeting 2021. News release. May 3, 2021. 

https://news.sunovion.com/press-releases/press-releases-details/2021/Sunovion-Presents-Data-From-Marketed-and-Late-Stage-Development-Psychiatric-Compounds-At-The-American-Psychiatric-Association-APA-Annual-Meeting-2021/default.aspx

Data presented at the 2021 APA Virtual Annual Meeting show promise for treating schizophrenia.  

Late-Stage Pipeline Candidate Looks Promising for the Treatment of Schizophrenia 

“Ethical dilemmas arise when there are multiple ethical responsibilities that stand in tension with each other,” Charles Dike, FRCPsych, MBChB, MPH, told the attendees of the American Psychiatric Association (APA) Annual Meeting.

At a panel on “Ethical Dilemmas in Psychiatric Practice,” one dilemma stood out: the possible conflict between psychiatrists’ duties to their individual patients and their duties to promote the good of the public as a whole.

This conflict has become particularly pressing this past year due to the global pandemic, and the panelists considered the problem from several angles as they answered previously submitted questions.

One question concerned confidentiality: What should be done when a patient reports her parents are sending another child to school despite the child’s positive SARS-COV-2 virus results?

Daniel J. Anzia, MD, a member of the expert panel, explained “the participation in public health endeavors is a long-standing, recognized potential exception to the obligations of psychiatrists, and all physicians, maintaining confidentiality.” Past department chair for psychiatry at Advocate Lutheran General Hospital in Park Ridge, Illinois, Anzia said ideally the patient (who was no longer a minor) would make the report to the school, and then inform the family that public health officials might be contacting them. But, he added, if the patient refused, “it is permissible for the psychiatrist to make such a report.”

Another question asked what psychiatrists should do if patients insisted on being seen in person, even at the height of the pandemic. Panel member, Tia Patricia Powell, MD, Director of the 

, told attendees they are not required to put themselves at physical risk. “Among our many obligations as psychiatrists is to provide a safe space in which we can offer therapy for our patients. That includes keeping the patient and psychiatrist safe from each other in terms of communicating the virus,” she explained.

Powell noted that many psychiatrists have extended their own knowledge of telehealth, discharging their obligation to offer care in person by working with patients to make telehealth possible. If the patient refuses telehealth, protective gear, and vaccination, “it could be legitimate for a psychiatrist to say, ‘I’m not at this time able to continue working with you.’”

Along the lines of vaccinations, are psychiatrists obligated to get an available vaccine for SARS-COV-2? Although “a psychiatrist has a right to refuse the vaccine, the psychiatrist should consider their wider obligations of such a decision, including an unspoken statement—to the psychiatrist’s colleagues and patients—that the psychiatrist does not trust the vaccine,” said Dike, associate professor of psychiatry at Yale School of Medicine and associate program director of its 

. “This could discourage vulnerable patients from taking what could be a life-saving intervention.”

What are the obligations of a psychiatrist to a new patient who has yet to be seen? The panel was presented with a situation in which a patient fills in a reports suicidal thoughts on a new pre-visit questionnaire, and then does not come to the appointment or answer calls. Should the psychiatrist send someone to check on the patient?

Panelist Rebecca Brendel, MD, JD, detected a potential conflict between the psychiatrist’s duty to the individual patient and the public at large. “We’d hate to say we’re not going to screen patients for suicidality because it’s too hard to figure out what to do with the information,” said Brendel, assistant professor of psychiatry at Harvard Medical School and director of its Master in Bioethics program. However, she noted the need for a follow-up mechanism that does not overstep the bounds of a nascent doctor-patient relationship by violating the prospective patient’s rights to privacy and confidentiality.

One of the more controversial topics over the past few years has been what psychiatrists—or the APA as a whole—should say about the national psyche and potentially dangerous political leaders or movements. Brendel quickly reaffirmed the 

 but also insisted that “psychiatrists can participate in public life by adding insight and knowledge about mental health more generally.” For instance, psychiatrists might use their knowledge of history and psychology to “make some comment about what might lead groups of persons to become susceptible to certain beliefs, be prone to questioning authority in violent ways, and also to be thinking about how unrest or extremism or discriminatory views might affect certain members of our society, and in particular their mental health.”

Striking a balance between obligations to patients and society during a plague year might seem like an exceptional circumstance, but Philip Candilis, MD, reminded attendees that medical ethicists have previously faced similar situations. In fact, Candilis, professor of psychiatry and behavioral sciences at George Washington University School of Medicine and Health, noted that the field of medical ethics arguably began during a deadly outbreak. “When Thomas Percival wrote his 

, it was in response to the typhus epidemic in Manchester [UK],” Candilis said. During the plague, doctors fled the city, leaving many patients without care. In response the government demanded new professional guidance and ethical standards for physicians, 

Several decades later, the American Medical Association adopted Percival’s standards. The ethical dilemmas with which he grappled remain relevant today, and they will likely come up again. “How do you protect yourself as a doctor,” asked Candilis, “How do you protect your family, and how do you work for the public good at the same time? This is a difficult, difficult balance to strike.”

The panel reminded attendees that ethics resources and official APA opinions could be find on the APA’s Ethics webpage 

https://www.psychiatry.org/psychiatrists/practice/ethics

. Queries can be submitted to the APA’s Ethics Committee staff liaison for further guidance at apaethics@psych.org. Similarly, 

 readers can submit ethical dilemmas to our Ethics Editor via 

What’s a psychiatrist to do? An APA ethics panel at the Annual Meeting considered various dilemmas, including possible conflicts between physicians’ obligations to individual patients and their obligation to promote the public good. 

Expert Panel Ponders What It Takes To Be an Ethical Psychiatrist  

H. Steven Moffic, MD, discusses the significance of topics surrounding birthdays, such as signature birthdays and their increased rate of suicide for men. 

is an award-winning psychiatrist who has specialized in the cultural and ethical aspects of psychiatry. A prolific writer and speaker, he received the one-time designation of being a Hero of Public Psychiatry from the Assembly of the American Psychiatric Association in 2002. He has recently been leading Tikkun Olam advocacy movements on climate instability, burnout, Islamophobia, and anti-Semitism for a better world. He serves on the Editorial Board of 

Take a closer look into the meanings of birthdays...

A Psychiatric Association to a Birthday

is head of the OECD New Approaches to Economic Challenges Unit.

The impact of the COVID-19 pandemic on women around the world has been both troubling and illuminating. Record numbers of women have had to drop out of the workforce, and 

 There has been a 25 to 300%increase in reported cases of domestic violence against women

 Although death and hospitalization rates related to the pandemic have been higher for men than women, the COVID-19 brain health crisis (everything from depression and anxiety to neurological disorders like Alzheimer disease) has disproportionately affected women. What are the reasons underlying this inequity, known as the “The Brain Gap”? What are the impacts on children, families, communities, and future generations?

Closing the gap will require a comprehensive and systematic approach to the addressing gender equality. Getting more women in research and health care is a good first step, but it is not nearly enough. To improve women’s mental health, we must incorporate new data: namely, the perspective and experience of women. Solutions that consider the experience of women are more likely to create structural change across sectors, from neuroscience and health care to racial equality, public policy, and workplace norms.

Biological, sociocultural, and economic factors are relevant to understanding and promoting gender health, and to elucidating and reducing gender disparities. At the most fundamental level, neuroscience and clinical research have not sufficiently incorporated sex and gender-based differences into their understandings the disease development, or the subsequent treatment considerations. Accounting for sex and gender differences is a must if we want to move from a one-size-fits-all medical model towards precision medicine, where big data and artificial intelligence may enable personalized solutions.

For example, as of 2019, Alzheimer disease and other forms of dementia are the 7th leading cause of death globally, with women accounting for 

 Unfolding research demonstrates that current strategies to address the ever-growing care burden and cost of dementias have not adequately considered sex and gender differences in the molecular presentations of the illness.

 Nor have they considered the gender-specific biological and socio-cultural risk factors, rates of disease progression, or considerations for community management to ensure equity in care.

The interactions with the reproductive system are crucial for brain health and aging in women. Menopause, surgical menopause, preeclampsia, higher rates of depression, primary caregiving, and lower education levels are risk factors for developing dementia.

 These findings, however, have not changed the way we contextualize and treat these conditions. Decreasing levels of estrogen in perimenopause can contribute to issues with cognitive performance that sometimes resolve post-menopause, but have also been found to increase rates of dementia-related cognitive decline.

 Such insights can influence the way we tailor and prescribe treatments to women with Alzheimer disease.

The conversation about women’s equality must not be limited to cisgender white females. Because brain health disparities are exacerbated in racial-ethnic minorities and other underserved and marginalized groups, accounting for the impacts of interpersonal violence, racism, casteism, poverty, trans and homophobia is the only way to truly achieve gender equality and, ultimately, economic and social prosperity. For example, posttraumatic stress disorder (PTSD) was originally considered to be an illness of combat veterans, but it is much more likely to develop in women as a result of sexual assault and intimate partner violence.

 The latter is unfortunately highly prevalent in minoritized communities, and studies have shown that women of color and of lower socioeconomic status have very high rates of PTSD.

 These discrepancies exist for other mental illnesses and syndromes, including depression, anxiety, attention-deficit/hyperactivity disorder, substance use disorders, migraine, and trauma-related disorders.

 Such insights must be taken into account in next generation health care solutions for women.

Research institutions are calling for the inclusion of a more diverse array of women in preclinical development and in clinical trials, and the expansion of research design to focus on culturally relevant experiences in order to collect more 

 Furthermore, in order to translate this data into action, we must promote female leadership in health care and public health efforts. Although the majority of the long-term care workforce is female and the majority of residents in nursing homes are women, women remain underrepresented in health care leadership, underlining the lack of gendered consideration in 

Unfortunately, while the number of women employed and promoted in the workplace had been slowly trending up prior to the pandemic, COVID-19 may have halted that 

 In the United States, more than 2.2 million women have dropped out of the labor force in the 

 Women of color have been disproportionately laid off or furloughed, while others have had to tend to caregiving and primary provider responsibilities at home.

Unfortunately, these trends will have lasting consequences. For example, markers of scientific productivity decreased by 30% for women during the pandemic, whereas productivity for men 

The COVID-19 pandemic has exacerbated mental health and gender inequalities around the world. Understanding the causes is the first step toward finding solutions. 