New research indicates that male sexual dysfunction is more common in patients with restorative ileo anal pouch anastomosis (IPAA) after proctocolectomy, a surgery commonly used for patients with ulcerative colitis, than it is in the general population.

2022 Digestive Disease Week (2022) Annual Meeting

 in San Diego, Taha Qazi, MD, Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, explained the results of a new study and what the knowledge of an increased risk of male sexual dysfunction can do for patients.

Qazi said that male sexual dysfunction is likely more common in these patients because of nerve damage caused by the surgery.

Overall, males who have this surgery have twice as likely chance of having male sexual dysfunction.

“This is something that’s common,” Qazi said. “One of the things we don’t talk about as clinicians and physicians is male sexual dysfunction with our patients.”

He said the data should give clinicians comfort to begin conversations with patients because it might be more common than previously believed.

The study, which looked at more than 40,000 patients with ulcerative colitis who had IPAA found 1940 cases of male sexual dysfunction. However, Qazi said the surgery is absolutely necessary for many and the sexual dysfunction can be treated with available medications.

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Patients who have IPAA are more than twice as likely to suffer from male sexual dysfunction.



Taha Qazi, MD: Male Sexual Dysfunction Following Ulcerative Colitis Surgery

New findings suggest the microbiota-based investigational live biotherapeutic, RBX2660, restored microbiome and bile acid compositions concurrent with clinical response in patients with recurrent C.difficile infection. 

The findings additionally suggest the restorative changes may be characteristic of shifts from a post-antibiotic dysbiosis state to a healthier state.  

Digestive Disease Week 2022 Annual Meeting, 

Ken Blount, PhD, Chief Scientific Officer, Rebiotix and VP Microbiome Research, Ferring Pharmaceuticals, provided his perspective on the poster of distinction. 

Blount noted that the investigational treatment at one week of treatment led to a restoration of both bacteroidia and clostridia in the 3 clinical trials, which continued until the end of the follow-up period, including up to 24 months.  

"All of that told us that we were doing what we set out to do, which was to shift the microbiota in those trials from before to after treatment in a way that we felt could help resist or reduce recurrent C Diff infections," Blount said. 

From the bile acid analysis in the study, investigators observed that prior to treatment, secondary bile acids were very low and primary bile acids were very high. After seven days of treatment in these trials, they found restoration towards predominance of the secondary bile acides produced by healthy microbiota. 

"That sets up a very clear model in which prior to treatment patients are very vulnerable to see deferred growth and potentially recurrence whereas after treatment in these trials, they shifted to a state that you would call colonization resistance," Blount explained. 

Blount continued to discuss safety signals of RBX2660, using the investigational agent for treatment of other diseases outside of C.diff, and the potential for other studies looking into the biotherapeutic. 

The study, "Microbiome and Bile Acid Restoration Was Consistent Across Three Clinical Trials of RBX2660 for Recurrent Clostridiodes Difficile Infection: A Combined Analysis," was presented at 

Dr. Blount discusses the DDW 2022 poster of distinction on the investigational live biotherapeutic. 

Ken Blount, PhD: Effect of RBX2660 on Microbiome and Bile Acid Composition 

What leads the other: the diagnosis or the therapy? In the case of 

, major developments in both is leading to an inflection point when innovative clinical research and emerging disease definitions are simultaneously influencing each other.

American Psychiatric Association (APA) 2022 Annual Meeting

 roundtable to discuss possible revisions and additions to the the fifth-edition Diagnostic and Statistic Manual of Mental Disorders (DSM-5), Jonathan Alpert, MD, PhD, chair of the department of psychiatry and behavioral sciences at Montefiore Health Systems and Albert Einstein School of Medicine, discussed what he called an exciting time of change in his field.

“(We have this) convergence of an increasing array of evidence-based psychotherapies that are really based on specific features like prolonged grief—or other features that have been noticed as part of the human experience but previously did not have a diagnosis associated with them,” Alpert said.

At the same time, neurobiological research is helping inform mental disorder and addiction pathophysiology that which remains in a “rudimentary stage,” Alpert said.

“But some of the work in looking at broad dimensions like attention or motivation are advancing that kind of work—looking at molecular targets that may not be specific to schizophrenia or depression, but may cut across multiple diagnoses and may suggest new treatment agents that work on these molecular targets,” he explained.

The end result may be new therapeutic agents that target “aspects of diagnosis,” despite not being formally labelled an antidepressant or antipsychotic.

“There’s so much heterogeneity in psychiatry—people come in all shapes and sizes, and being able to come up with treatments and ultimately, predictors for who does best with which of those combinations of treatments (is the goal),” Alpert said.

On the subject of current psychiatric clinical trial standards, Alpert believed the field is still lagging behind the innovations in disease definition and care strategies, noting trials are often designed around existing DSM categories and not dimensions of behavior.

“It’s been over the past decade a continued journey to try and develop meaningful clinical trials that take into account some dimensional measures, but also respect the fact that they’re presenting within specific categories,” he said.

At the same time, psychiatrists are seeking more meaningful clinical trial outcome measures for both their sake and that of the patient—the latter of whom is much more fixed on improving measures of daily life rather than arbitrary scales of disease severity. “It’s still a journey to try and join those 2 worlds,” Alpert said.

Lastly, Alpert considered the idea that mental health is “ultimate comorbidity” in medicine, and whether that contributes to the burden of refining the multitude of sought-after outcomes in psychiatry’s clinical research.

“Almost always, a major determinant of outcomes is psychiatric comorbidity,” he said. “At the end of the day, those are the things that count for people—their quality of life, and even their length of life, is affected very much by whether they have a mental disorder or a substance abuse problem.”

Amid significant psychotherapy innovation and consideration to broader aspects of mental illness definition, Jonathan Alpert, MD, PhD, emphasizes the need for improved clinical trial standards.

How Evolving Psychiatric Definitions Set the Tone for Care

Cariprazine (VRAYLAR) provided statistically significant benefit versus placebo in Montgomery-Åsberg Depression Rating Scale (MADRS) total score change as an adjunctive therapy for adults with 

merican Psychiatric Association (APA) 2022 Annual Meeting

 in New Orleans this week, a team of Abbie-supported investigators reported a 1.5 mg dose of the atypical antipsychotic therapy was effective in improving MADRS and anxiety per Hamilton Anxiety Rating Scale over 6 weeks among older patients without prior response to standard-care antidepressant therapy.

Cariprazine was also observed to be well-tolerated and safe as an adjunctive therapy to antidepressant medication in the patient population, further suggesting its potential utility as an MDD agent.

 during APA 2022, study author Gary Sachs, MD, associate professor of psychiatry at Massachusetts General Hospital, discussed the impact of the phase 3 findings as they relate to complementing standard MDD care.

“Cariprazine is an interesting compound, because it now has been studied in schizophrenia, manic and mixed states of bipolar depression, and now finally, MDD,” Sachs said. “What’s happened as we as a field have learned how to use (standard antidepressants), we’ve gotten comfortable moving patients from one to another—even though, for instance, the STAR*D results show us that the law of diminishing returns happen almost immediately.”

Sachs discussed the observed MDD patient population in the phase 3 trial, whose mean age of 44.8 years old underscores the reality that they’ve likely been burdened with treatment-unresponsive depression for decades.

“To have some drugs now with proven efficacy added on to the standard drugs to take away that forced choice…now we have another kind of option, and I can say to a patient, ‘This has been proven to have efficacy for the diagnosis you have’,” he said.

In this role as an efficacious adjunctive therapy, cariprazine would also be a “fault-tolerant” option, Sachs said. A patient reliant on standard short-acting antidepressant regimens has more pressure to adhere to daily care.

Though 1.5 mg cariprazine fared better in efficacy outcomes than 3 mg doses, Sachs said more interpretation into dosing and long-term use is still under work. He also expressed interest in seeing the benefit of cariprazine in treating patients with anxious distress.

“In turns out the biggest predictor of who’s not going to respond (to antidepressants) are those subject to, in addition to low mood, symptoms of anxiety,” Sachs said. “That is clearly a more worrisome, less responsive group. And in this study…you see a benefit on the Hamilton Anxiety Rating Scale, which is intriguing, but we don’t really have all the breakout of data to know whether this is a beneficial drug for those who meet anxious distress.”

The study, “Cariprazine for the Adjunctive Treatment of Major Depressive Disorder: Results of a Randomized Phase 3 Placebo-Controlled Study (Study 301),” was presented at APA 2022.

New phase 3 data presented at APA 2022 support the agent as an adjunctive in older patients without benefit from monotherapy antidepressant medication.

Adjunctive Cariprazine with Antidepressants Benefits Adult Major Depressive Disorder

 in New Orleans this weekend convened to review the Diagnostic and Statistic Manual of Mental Disorders, which is currently in its fifth edition with a text revision from this past year (DSM-5-TR).

The review of the standard for mental conditions came at what one committee member called a “very interesting inflection point” for the future of 

—a time when ideas around contextual factors of health are being considered more directly in diagnoses and care.

 during APA 2022, roundtable member Jonathan Alpert, MD, PhD, chair of the department of psychiatry and behavioral sciences at Montefiore Health Systems and Albert Einstein School of Medicine, discussed the growing embrace of both social determinants of mental health in reviewing the DSM—as well as “broad dimensions of behavior” including attention or motivation that are present in most psychiatric conditions.

“The idea is, how do you integrate those 2 worlds: the world that looks at things in terms of specific diagnoses…and the world that looks at broad dimensions which might have their own neurobiologic underpinnings and social factors that contribute to them,” Alpert said.

Alpert additionally discussed the roundtable’s discussion around addressing measurements of psychiatric function—moving from a previously-shelved clinician-based score that introduced bias to clinical scales of function, to model similar to the World Health Organization Disability Assessment Scale (WHODAS) 2.0.

“The very nice thing about the WHODAS scale is that it’s been studied across more than 30 countries, it’s translated into multiple languages, it’s a self-assessment form that patients can fill out on their own,” Alpert said. “Their clinicians can fill it out, their guardians can fill it out…and it asks about different domains of function.”

Alpert praised the scale’s flexibility—asking patient perspective on various factors and lifestyle behaviors that constitute function—and use of “concrete questions.”

“In many ways, it breaks down the traditional barriers between mental functioning and the rest of function, because they’re really all interconnected, when you think about it,” Alpert said.

On the matter of seeking new definitions for future DSM editions, Alpert said there’s many areas that psychiatrists are still “trying to get a better grasp on.” He cited the text revision’s addition of prolonged grief disorder to differentiate major depression from bereavement-borne mental issues—as well as still-lacking refinements in eating disorders—as evidence of missing work in psychiatric diagnoses.

“An attempt continues to be made—and this will continue for years—to try to notice what are the clinical scenarios and conditions that people are recognized to have that somehow haven’t had a home in DSM,” Alpert said.

Montefiore psychiatry chair Jonathan Alpert, MD, PhD, discusses suggested updates to the DSM-5—with consideration to social determinants and patient-reported functioning.

How Mental Illness Definitions Are Still Being Uncovered and Refined

Disaster psychiatry is coming into its own as an informal subspecialty, warranted by the increasing prevalence of natural weather events and societal turbulence.

How these events affect younger generations not only acutely, but in their long-term development, may be dictated by the response of a disaster psychiatry care team.

 in New Orleans this week, Linda Chokroverty, MD, child psychiatrist and assistant professor in the department of psychiatry and behavioral sciences at the Albert Einstein College of Medicine, discussed the importance of timely and coordinated psychiatric care in children impacted by disasters and trauma.

“That really starts at the family and school level—trying to educate parents and teachers about how children react to different situation,” Chokroverty said. “Younger children in particular may have misunderstandings of what happens if there’s, say, a storm.”

With psychological development being critical in early years of exposure to such events, Chokroverty stressed the severe reactions children may have to disasters—increased fear and anxiety, and a desire to avoid social gatherings or school are among the more common effects.

“They may not want to leave home because they think something terrible is going to happen all the time,” she said. “So psychoeducation is one of our most important tools as psychiatrists in our daily work—both in and out of disasters.”

Regarding the pediatric disaster psychiatry care team itself, Chokroverty emphasized clear communication among all impactful adults: parents and guardians, primary care providers, teachers, and specialists. They key is to ensure the focal point of care—the parents—are provided appropriate resources and clear education.

“They’re the best equipped to help their children,” Chokroverty said. “Importantly, we do want to help parents understand what they communicate to their children is important—and what they don’t communicate to their children can also be important or even a problem. If they don’t explain things to children, then they’re going to have more misunderstandings and stress, and that’s preventable.”

Lastly, Chokroverty reminded her colleagues to consider additional circumstances which may make a young individual more susceptible to mental health impact following disasters: those who have lost parents or guardians, those with developmental disabilities or a mental illness, and those with prior trauma, to name a few groups. She also emphasized the impact of cultural, racial and socioeconomic context in disaster response.

“If they’re more disadvantaged to begin with, they’re going to have a lot more struggle to try and recuperate after having a major setback like COVID-19, mass violence or a major natural disaster event,” she said.

Linda Chokroverty, MD, discusses the significance of timing, communication and care coordination when children are affected by disasters or trauma.

The Pediatric Disaster Psychiatry Care Team

 announced that Rebecca W. Brendel, MD, JD, was chosen as the society’s next president-elect, following the conclusion of this week’s annual meeting in New Orleans.

Brendel, director of the Master’s Degree Program at the Harvard Medical School Center for Bioethics, assistant professor of 

 at Harvard, and a psychiatrist at Massachusetts General Hospital, provides a unique background in clinical work and bioethics leadership that may perfectly suit her prize goal as APA president-elect: “the roadmap to the future.”

 while at APA 2022, Brendel discussed a series of major topics headlining the annual meeting—as well as those which may permeate through her presidency and beyond. She spoke to this year’s theme of Social Determinants of Mental Health—a subject which given increasing natural disasters, political and global instabilities and the ongoing COVID-19 pandemic is now more relevant than ever.

“We know the places where we live can affect our mental health, which then affects our physical health,” Brendel said. “We have a system and structure that leads to disparate effects of those who have the most and need the most.”

On the subject of mental health disparity, Brendel discussed the understood roles of factors including race and socioeconomic status in determining likely outcomes for affected patients. She pointed to the efforts to “objectively allocate critical care resources” during early response to COVID-19—an effort which fell short when realizing the disparate impact of the virus alone on Americans.

“What we failed to recognize is the depth and breadth of these challenges and disparities—so much that in particular for Indigenous and Black Americans, they died in nearly twice their population share from COVID-19,” she said.

Brendel highlighted a session she would be leading at the meeting in New Orleans that touched on the disparate impact of Hurricane Katrina 2 decades ago—a natural disaster that coupled with the city’s historic challenges in population density and poverty rates to create an exponentially worse mental health crisis for well after the hurricane.

“The fact we were not prepared for the disparate impact of COVID-19 and the fact that we’ve had so much trouble learning is something we’ll have to reckon with for decades to come,” Brendel said.

Regarding the booming research and application of novel psychiatric drugs including ketamine and psilocybin, Brendel touched on the need for ethical, legal and regulatory guidelines to ensure care and research remains appropriate for the field—all the while acknowledging that these drug classes may bring long sought-after change to the field.

“It’s such a great question, because innovation is so critical to being able to effectively to treat mental illness in particular—where we’ve lagged behind in completely novel therapeutics compared to other areas of medicine for a very long time,” Brendel said.

Lastly, Brendel discussed her roadmap to the future of psychiatry, which she said will include efforts to prepare the field and organization for the “unprecedented mental health demands coming from the post-pandemic era.”

“Many have called it a twin mental health pandemic,” Brendel said. “We’re looking across public engagement, supporting psychiatrists in the profession, and policy initiatives to ensure that once and for all, we can achieve our aim of making mental health care available for every American and actually putting into practices that there’s no health without mental health.”

APA president-elect Rebecca W. Brendel, MD, JD, discusses the need to prepare for a "twin mental health pandemic" while continuing to appropriately facilitate innovations in psychiatric care.

Understanding Socially-Determined Mental Health and the Impact of COVID-19

Investigational, once-daily oral therapy zuranolone provided rapid, sustained, and well-tolerated benefit for patients with either postpartum depression (PPD) or 

 over a series of 14-day regimen clinical trials.

In a new poster highlighting the phase 2 and 3 clinical program for the Sage Therapeutics neuroactive steroid and GABA

 in New Orleans, zuranolone provided significant improvement in outcomes including the 17-item Hamilton Depression Rating Scale (HDRS) not only at day 15 post-baseline, but after 1 year in the open-label SHORELINE trial extension.

at APA 2022, poster presenter Anita Clayton, MD, chair of psychiatry and neurobehavioral sciences at the University of Virginia School of Medicine, discussed the details of the zuranolone clinical trial program for patients with PPD or MDD—populations which for some time have needed more novel therapies.

“Depression treatment has really not advanced a lot in the last 20 years,” Clayton said. “A new mechanism of action is pretty exciting because there’s still many people who don’t respond to the standard-of-care treatments that we have currently.”

Clayton highlighted the agent’s 15-day improvement in not only patients’ HDRS scores, but similar benefit in the Montgomery Asberg Depression Rating Scale (MADRS) and Clinical Global Impression of Improvement (CGIC). All the while, zuranolone was associated with similar adverse events to placebo.

“It’s not that hard to tolerate something for a 14-day course you take before you go to sleep,” Clayton said.

Clayton further detailed the drug’s unique mechanism of action that may prove it to be a more viable option for these in-need patient populations.

“By being an allopregnanolone analog, it binds to GABA

 receptors and acts an agonist—and GABA is the primary mechanism in the brain, it’s on like 30% of all synapses,” Clayton said. “It also binds to these extra synaptic receptors elsewhere that seem to help with this rapid and sustained response in a very different way than benzodiazepines.”

The poster, “Sustained Improvement in Depressive Symptoms: Results From Zuranolone Clinical Development Program (Major Depressive Disorder/Postpartum Depression),” was presented at APA 2022.

Anita Clayton, MD, reviews the available phase 2 and 3 clinical data for the novel, once-daily oral investigative drug.

Zuranolone Benefits Major Depression, Postpartum Depression in Clinical Program

As disaster-level events become more prevalent globally, a greater proportion of people are being exposed to potential trauma. From this trend has come a growing prevalence of 

—an informal focus of mental health care for decades that is becoming more vital.

 in New Orleans, Linda Chokroverty, MD, assistant clinical professor of psychiatry and behavioral sciences and pediatrics at Montefiore Health Systems and the Albert Einstein College Of Medicine, discussed the state of disaster psychiatry—a field which emerged about 40 years ago.

“It’s really a subset of psychiatry—but not necessarily so, because it involves regular psychiatrists most of the time,” Chokrovery said. “There’s some people who really become experts in the field and spend more time studying it. They would be more the specialists in the realm, but by and large, disasters are very common and increasing because of the climate situation.”

As Chokroverty explained, psychiatrists are often “inadvertently” providing aide in the event of disasters, which are capable of affecting anyone’s mental health regardless of their location or severity. Though Chokroverty and colleague’s session at APA 2022 focused on disaster psychiatry for children, the role of a family system in addressing pediatric mental health essentially makes the topic applicable to all parties.

Key symptoms of disaster-based psychiatric harm include anxiety, uncertainties about the future, fear, poor sleep health and a general sense of unease, Chokroverty said. “And that’s pretty normal, and part of our job as psychiatrists is to help people understand that…provided we do our best to resume routines and structure,” she said.

On the subject of improving affected children’s sleep, Chokroverty said it’s critical to consider a multitude of factors—from the sleep habits modeled by parents and guardians, to the resources any physician can provide that promote sleep health.

“Sleep is difficult to improve when you’ve had a lot of disruption, especially if you’ve had highly traumatic experiences,” she said. “It’s important still to try and maintain structure in the form of good sleep-promoting habits.”

Linda Chokroverty, MD, discusses the role psychiatrists play in managing the mental health effects of disasters, and how children specifically may be impacted.

The Need for Disaster Psychiatry Care

Like many public health crises, climate change does not affect all Americans equally. In fact, as 2 collaborating psychiatrists discussed with 

, the most historically oppressed populations are facing a greater—and more diverse—brunt of the 

 in New Orleans this weekend, a pair of New Mexico psychiatrists discussed the relationship between social determinants of mental health and climate change—particularly among Black, Indigenous and people of color (BIPOC).

Edward J. Neidhardt, MD, a psychiatrist with Christus St. Vincent Regional Medical Center, discussed the burden of “eco-anxiety” in younger US generations; as he noted, long-term decisions like whether to start a family, or even their perspective on the future itself, can be severely impacted by the psychological effect of environmental crisis.

“Many of them have eco-anxiety, and that amount of anxiety has been increasing over the last few years—a lot of it because of climate change and our political situation as well,” Neidhardt said. “As you get anxious, you tend to see things in a more negative way.”

Neidhardt emphasized the need to “empower” affected patients to contribute to solutions against their greatest worries; a solution to eco-anxiety can be as simple as being more active in environmental protection or rehabilitation.

But the issue may be greater in BIPOC communities, where outside contributing factors to mental health—such as poverty rates or lacking resources to care—are coupled with generally worse exposure to climate change.

Mary Hasbah Roessel, MD, a psychiatrist with Santa Fe Indian Hospital, is Navajo. She discussed how she has observed the impact of “historical trauma” on mental health outcomes among BIPOC in both her personal experiences and as a practicing psychiatrist.

“When you have indigenous people who have been displaced, forcibly removed from their homes to go to boarding or residential schools…you have the impact of having to deal with regaining your culture, your values, your family systems again,” she explained.

And, many of the reservations or regions where these populations have been settled into are more adversely impacted by climate change. “It’s a really devastating combination of circumstances,” Roessel said.

Roessel also discussed the unique impact of climate change on the mental wellbeing of indigenous people who historically practiced “living within the land” in their culture.

“Adverse weather events, climate change, all of these issues become more pertinent and devastating for us, in terms of poverty and food insecurity especially,” she said.

Neidhardt discussed the need for broadened perspective on the contributing factors to mental health.

“In dealing with this, we really need to take a broad look at how we cope, and how we teach our patients, both dealing with acute symptoms of anxiety but also if they have PTSD, taking more active treatments…and looking at the other factors such as housing, employment, and all the things that impact people as well,” he said.

A pair of psychiatrists discuss how climate change and other social determinants of health are affecting the mental wellbeing of indigenous people.

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