Students With Psychosis Honored as STARR Advocate of the Year

At the 2025 STARR Annual Award Celebration, Students With Psychosis (SWP) was honored as this year's STARR Advocate of the Year -- recognizing a year of thoughtful, steady leadership on behalf of young people living with serious mental illness.

Throughout 2025, SWP continued to strengthen its role as a national voice for students and young adults with lived experience of psychosis. Through leadership development, peer community-building, education, and public speaking, the organization has created space for young people to be seen not only as patients, but as leaders and changemakers.

2025 marked meaningful growth in SWP’s reach and influence. The organization partnered with One Mind on the Launchpad initiative, helping expand employment opportunities for young adults living with serious mental illness. SWP also keynoted the NAMI Texas Conference, where student leaders were recognized on the main stage—an important moment reflecting broader acceptance of lived-experience leadership.

In addition, SWP presented at major gatherings including the SAMSHA CHR/FEP Conference, the International Early Psychosis Association's International Early Intervention Conference, and events at Stanford University, contributing to conversations on early intervention, stigma reduction, and interdisciplinary collaboration.

Founder and executive director Cecilia McGough has consistently grounded this work in a simple but powerful truth. As she once wrote, “The good guys get SMI too, and the overwhelming vast majority of people living with serious mental illness are the good guys.” That conviction—clear-eyed, direct, and human—continues to shape SWP’s mission. It reframes psychosis not as a character flaw or cautionary tale, but as a health condition experienced by thoughtful, ambitious, and capable individuals.

The award was accepted by Cecilia and presented by Gordon Lavigne of Schizophrenia & Psychosis Action Alliance, last year's Advocate of the Year.

Students With Psychosis continues to model what grounded, community-centered advocacy can look like, bringing lived experience, partnership, and practical action together to create lasting change. For more information on Students With Psychosis, visit their website and be sure to check out Cecilia's blog posts, which are phenomenal.❤

Each March, Criminal Justice Month offers a moment to reckon with the uncomfortable reality that the U.S. criminal justice system has, by default, become the largest mental health care provider in the country. An estimated 44% of people in jails and 37% in state and federal prisons have a history of mental illness, compared with roughly 18% in the general population.^1,2

With more than 1.2 million people living with mental illness behind bars each year, county jails and prisons are now de-facto mental health institutions, despite limited resources, inconsistent care, and significant treatment gaps.

While correctional facilities are constitutionally obligated to provide health care, including mental health services, many incarcerated individuals either receive inadequate care or lose access to necessary treatment altogether. For example, among people entering prison already on psychiatric medication, more than half may not continue receiving that medication while incarcerated — a stark failure in continuity of care.

Why Isn’t Clinical Research Offered to Incarcerated People?

The notion of offering clinical research to incarcerated people is ethically complex. Federal regulations classify prisoners as a vulnerable population due to limited autonomy and heightened risk of coercion — protections rooted in a history of unethical experimentation. These safeguards are essential, but they have also resulted in near-total exclusion from many clinical trials.^3,4

Yet categorical exclusion raises its own ethical concern. Incarcerated individuals represent one of the largest populations living with serious mental illness. Denying them access to investigational treatments may unintentionally create inequity — limiting their ability to benefit from innovation, contribute to scientific advancement, and be represented in the evidence base that informs care.

Reconsidering access would require strong structural safeguards: independent prisoner advocates in the consent process, clear separation between correctional authorities and recruitment, strict limits on incentives, guarantees that participation has no impact on privileges or parole, and external oversight with prisoner representation. Prioritizing lower-risk research — such as pragmatic trials of approved medications, observational studies, and continuity-of-care research — may offer a responsible starting point.

The question is not whether to open prisons to all trials, but whether we can design a framework that protects autonomy while preventing exclusion.

A Pragmatic Step Forward

While broad inclusion of incarcerated people in clinical trials remains ethically and legally constrained, there are practical, humane actions we can take now:

• Partner with local jails and prisons to ensure individuals prescribed psychiatric medications while incarcerated are provided comprehensive resources about clinical research opportunities upon release.

• Create tailored referral lists of nearby research sites and support individuals’ transitions into community-based care that may include access to clinical studies.

These steps honor both ethical safeguards and the basic human right to care and opportunity — helping break cycles of untreated illness, recidivism, and marginalization.

***

1.SAMHSA: About Criminal and Juvenile Justice

2.MHA: Access to Mental Health Care in Prisons

3.HHS: Prisoner Research FAQs

4.PubMed: Ethical and Social Issues in Health Research Involving Incarcerated People

Be A Part of Forming the First-Ever National Mental Illness Justice Center

Join The STARR Coalition in DC on April 23 to help build the foundation of the National Mental Illness Justice Center at a gathering co-hosted by the Schizophrenia & Psychosis Action Alliance and the Treatment Advocacy Center. 

Participate in a structured working session designed to define the guiding principles for the Justice Center and produce a blueprint of potential elements, including legal toolkits, model policy standards, court and law enforcement education resources, connections to legal aid and pro bono counsel, referral pathways to treatment clinics and diversion programs, and clear guidance for families seeking informed support before situations escalate.

The one-day session will take place from 8 a.m. to 6 p.m. Eastern in Washington, DC.

Registration is $199.

Register now to secure your spot: https://donorbox.org/events/903272/steps/choose_tickets

The FDA has accepted Teva’s NDA for a once-monthly olanzapine extended-release injectable suspension for schizophrenia, advancing a long-acting option designed to support steadier adherence. Notably, Teva has highlighted that its formulation is intended to be used without mandatory 3-hour post-injection monitoring, which—if supported in labeling—could reduce a major logistical barrier to broader clinical use. The submission marks the start of the FDA’s formal review of Teva’s monthly olanzapine LAI program.

New data from two late-stage trials of Compass Pathways’ psilocybin-based therapy for treatment-resistant depression point to a clear path to the FDA. Compass revealed 26-week data from the Phase 3 COMP005 trial, in which a single administration of the candidate previously drove a 3.6-point MADRS reduction at six weeks. The company emphasized that COMP360 “maintained durability of effect at least through week 26 after just one or two doses.”

The FDA has approved Vanda Pharmaceuticals’ Bysanti (milsaperidone) for the treatment of acute bipolar disorder and schizophrenia, introducing a new atypical antipsychotic option. The approval was supported by multiple clinical studies in schizophrenia and bipolar I disorder, along with pharmacokinetic bridging data from Fanapt (iloperidone), of which Bysanti is an active metabolite. Vanda is also exploring additional uses, including a Phase 3 study of Bysanti as an adjunctive treatment for major depressive disorder, with results expected in 2026.

Denovo Biopharma and Orygen have partnered to launch a Phase 2 study of pomaglumetad methionil for psychosis, revisiting a glutamatergic mechanism aimed at improving outcomes in schizophrenia-spectrum disorders. The collaboration will evaluate the therapy using biomarker-informed patient selection strategies to offset the previous research on pomaglumetad methionil, in which the drug failed to show efficacy in clinical trials, but may be effective in certain patient populations.

Helus Pharma reports that its Phase 2a trial of SPL026 met key endpoints for treating major depressive disorder, demonstrating significant improvements in depressive symptoms following psychedelic-assisted therapy. SPL026, an intravenous formulation of dimethyltryptamine (DMT), was evaluated as a rapid-acting intervention for adults with MDD. The findings support continued clinical development of the therapy and add to the expanding evidence base for psychedelic-based treatments in mood disorders.

Cyclerion Therapeutics reports that its Phase 2 study of CYC-126 for treatment-resistant depression (TRD) will proceed following FDA feedback. The investigational therapy is an anesthetic-based therapy incorporating live electroencephalogram (EEG) feedback. The FDA’s guidance supports advancement of the study to further evaluate safety and efficacy in adults with TRD as Cyclerion continues development of the program.

Evecxia Therapeutics has dosed the first patient in a Phase 1b study evaluating EVX-301, an intravenous formulation of 5-HTP designed to amplify brain serotonin synthesis. The randomized, placebo-controlled trial will assess the relationship between plasma 5-HTP exposure and biomarkers of serotonin production in patients with depression already taking SSRIs or SNRIs. Results expected in Q2 2026 may help validate Serotonin Synthesis Amplification as a novel therapeutic approach for psychiatric disorders.

Addex reports new preclinical data supporting mGlu7 negative allosteric modulators as potential treatments for anxiety and fear-related disorders. Published findings show that targeting the mGlu7 receptor may regulate neural circuits involved in fear and stress responses, suggesting a novel therapeutic pathway. For mental health clinical researchers, the results highlight continued expansion of glutamatergic targets in psychiatric drug development and reinforce growing interest in mechanism-driven approaches to treating anxiety-related conditions.

A new study out of Sweden’s Karolinska Institute maps the prefrontal cortex (PFC) based on neuronal activity rather than physical structure, offering a more functional view of how the brain works. By analyzing over 24,000 neurons in awake mice, researchers found activity patterns that differed from traditional anatomical maps and revealed specialized neuron roles in information integration and decision-making. These findings suggest brain function is shaped more by connectivity and activity than structure alone, providing new insights into psychiatric disorders and potential pathways for future treatments.

Distinct immunological profiles may help differentiate schizoaffective disorder from schizophrenia and bipolar disorder, according to a recent study examining white blood cell markers across diagnoses. Researchers found that patients with schizoaffective disorder showed unique immune patterns and that their profiles were biologically closer to schizophrenia than bipolar disorder, including during manic episodes.

Neurocognitive impairment may not determine personal recovery in psychotic disorders, according to a longitudinal study of 366 individuals with schizophrenia-spectrum conditions. Over one year, measures of memory, attention, and executive function were not associated with patients’ sense of recovery, while psychotic symptom severity showed a stronger relationship. Importantly, recovery scores improved over time regardless of cognitive status. For mental health clinical researchers, the findings highlight the need to evaluate recovery and cognition as distinct domains when designing studies and measuring outcomes.

Early psychosis screening in adolescents and young adults may significantly improve long-term outcomes for schizophrenia. Clinicians emphasize that identifying symptoms earlier can shorten the duration of untreated psychosis, potentially reducing hospitalizations, treatment resistance, and long-term cognitive and functional decline. Experts also stress the need to evaluate the full symptom spectrum—including negative symptoms and general psychopathology—while recognizing that cognitive complaints may be misattributed to ADHD or anxiety. Long-acting injectable antipsychotics remain underused despite their potential to improve adherence and support individualized treatment strategies.

Complex PTSD may influence the brain pathways involved in psychosis, according to a neuroimaging study comparing people with schizophrenia-spectrum disorders with and without cPTSD. Participants with cPTSD showed structural differences in brain regions linked to emotion and fear regulation. The findings support emerging “affective pathway” models of psychosis, suggesting trauma-related biology may contribute to symptom development. For mental health clinical researchers, this highlights the importance of carefully assessing trauma histories and considering trauma-related subgroups in study design and analysis.

Oxytocin is emerging as a promising therapeutic target across several neuropsychiatric disorders, according to a recent review highlighting its anti-inflammatory, antioxidant, and neuroprotective properties. The neuropeptide influences key neurotransmitter systems and may improve social cognition and symptom severity in conditions such as autism, schizophrenia, depression, and anxiety. For mental health clinical researchers, the findings point to new opportunities in biomarker development, precision medicine, and novel delivery strategies—such as intranasal or nanoparticle-based approaches—to better translate oxytocin’s biological potential into clinical therapies.

Diagnostic stability varies widely in youth after a first psychiatric emergency visit, according to a 24-month follow-up study of 583 children and adolescents. Psychosis diagnoses showed the highest stability (71%), while eating disorders and conduct disorders were far less stable. Researchers also identified common diagnostic transitions, including links between autism with ADHD and later conduct disorders. For mental health clinical researchers, the findings highlight the value of longitudinal assessment and trajectory analysis when studying early-onset psychiatric conditions and designing developmentally informed research.

Psychedelic research continues to expand across multiple mental health conditions, with psilocybin showing promise for treatment-resistant depression and other psychiatric disorders as clinical trials advance. Researchers emphasize that “psychedelics” encompass a diverse group of substances—including psilocybin, MDMA, ketamine, and ibogaine—each with distinct mechanisms, benefits, and risks. Evidence suggests potential therapeutic effects, but safety considerations remain important, particularly for individuals with psychiatric conditions. Careful evaluation of each substance’s clinical profile is essential as research and potential therapeutic applications progress. (Editor’s Note: This article provides a comprehensive overview of psychedelic substances, their mechanisms, and safety considerations, and may serve as a useful resource for clinicians and researchers interested in becoming involved in psychedelic research or therapeutic development)

Psilocybin research continues to advance toward potential FDA approval, with growing evidence supporting its effectiveness for depression and other psychiatric conditions. As clinical use expands—and with therapeutic legalization already underway in states like Oregon, Colorado, and New Mexico—clinicians are encouraged to understand key safety considerations. Notably, lithium presents a significant drug–drug interaction risk and is strongly contraindicated. Other medications may blunt psilocybin’s effects, while benzodiazepines are generally preferred for managing anxiety during supervised psilocybin experiences. (Editor Note: this is a great article, listing key pharmacological interactions and other safety considerations)

Adjunctive lithium treatment substantially reduces relapse and suicidal risk in mood disorders, according to a naturalistic study of patients with bipolar disorder and major depressive disorder. After lithium was added to treatment, adverse clinical events declined from 32.8% to 10.5% within one year. Rates of suicidal ideation and suicide attempts also dropped sharply across both diagnostic groups. Researchers suggest lithium’s well-documented antisuicidal effects may extend beyond mood stabilization, potentially reducing mental pain and volatile emotional states linked to suicide risk.

The STARR Coalition Participates in Congressional Briefing on Decoding Mental Health Stigma

On February 4, 2026, The STARR Coalition joined national leaders in Washington, D.C., for Decoding Stigma: The Neural Science of Mental Health, a congressional briefing hosted by the Congressional Neuroscience Caucus in cooperation with the American Brain Coalition.

The panel, moderated by Dr. Mark Rasenick, featured Dr. Andrea Beckel-Mitchener (NIMH/NIH BRAIN Initiative), Dr. Mark Rapaport (American Psychological Association), Erica Moore (The STARR Coalition), Jeff Winton (Rural Minds), and advocate Andy Dunn. Congressman Mike Thompson (D-CA) and Congresswoman Jan Schakowsky (D-IL) were in attendance.

STARR’s goal in participating was clear: to ensure mental health research remains accessible, transparent, and worthy of public trust so that more Americans can benefit from timely, effective treatment. Elevating the voices of neuroscientists and clinicians on the frontlines of research is essential to ensuring that science informs policy and that advocacy reflects real-world expertise.

During the briefing, experts and advocates discussed how advances in brain science are reshaping our understanding of mental health conditions and why stigma remains one of the greatest barriers to seeking treatment and achieving recovery. What stood out most was the powerful integration of lived experience, scientific research, and policy dialogue working toward a shared mission: transforming how our nation talks about mental health.

Thanks to the American Brain Coalition for bringing together an amazing session and for inviting The STARR Coalition to participate in such an important conversation! ❤

Mental Health Courts – One Observer’s Perspective

by John Messenger, Mental Health Court Liaison, NAMI Rochester

Mental Health Courts are specialized “treatment” or “problem-solving” courts that offer an alternative to traditional criminal courts to address behaviors associated with or caused by mental illness. Mental health courts foster collaboration between the criminal justice system and behavioral health system, seeking to use the criminal judicial process to encourage and support participants in obtaining and engaging in clinically recommended treatment for mental health conditions and related substance use disorders (if there is the presence of a co-occurring substance use disorder).  


There are over 300 mental health courts in the United States.^[1] The requirements and procedures vary somewhat between states and localities. I currently serve as the liaison between NAMI Rochester, NY, the local affiliate of the National Alliance on Mental Illness, and the Monroe County Mental Health Court. I’ve had the opportunity to observe the court in operation over the last several years.


A defendant who has been charged with a misdemeanor or felony in a town, county or state court in Monroe County, and has a serious mental illness diagnosis, may have the opportunity to have their case transferred to the Mental Health Court for monitoring and disposition. This requires the approval of the prosecutor, defense attorney, and the presiding judge. The defendant must sign a Participation Agreement, agreeing to adhere to the requirements of the mental health court program. 

Mental Health Court requires the participant (1) to maintain frequent contact with court-assigned case managers or agency representatives, (2) to attend and participate in the clinically recommended course of behavioral health treatment (including taking prescribed medications and attending appointments), (3) to submit to random drug and alcohol testing (if there is the presence of a co-occuring substance use disorder), and (4) to appear in court with varying frequency depending on how well the participant is progressing toward the goals of their individualized treatment plan. Over the course of the mental health court program, a participant who is fully adherent can “graduate” and have the criminal charge reduced or withdrawn, in accordance with the negotiated terms of their Participant Agreement.



It takes time for most participants to adjust to sustainable recovery, and relapses are not uncommon. But the long-term, hands-on approach utilized by the Monroe County (NY) Mental Health Court, working cooperatively with treatment providers, is significantly more effective at achieving positive results than is the criminal justice system alone. 👤

John Messenger retired in 2021 after a 41-year career as in-house counsel with several telecom companies. He and his wife Judy have volunteered in various capacities with NAMI Rochester since 2006. In addition to serving on the board, John attends the Monday morning sessions of the Monroe County Mental Health Court, where he meets with defendants and family members and serves as a liaison between NAMI Rochester and the court.

John also serves on the board of the Coffee Connection, a local non-profit that employs and empowers women in recovery from addiction, trauma, and incarceration, and does a variety of pro bono legal work. He and Judy are active members of Asbury First United Methodist Church in Rochester.

[1] American Bar Association, “A Look at Mental Health Courts” (Sept 10, 2024),

In February, The STARR Coalition hosted the webinar Fueling the Future of Mental Health Research: Industry Leadership, Trust, and Policy in a Pivotal Moment, bringing together leaders from advocacy, industry, and clinical research sites to explore the forces shaping today’s mental health research environment.

A central theme of the webinar was the idea that trust functions as critical infrastructure within the mental health research ecosystem. While policy, academic institutions, industry sponsors, research sites, and community partners each play vital roles, trust is what allows the system to function effectively. Without it, even the strongest scientific advances struggle to translate into meaningful progress for patients and communities.

The panel explored this concept from multiple perspectives. Katie Sale of the American Brain Coalition discussed how national awareness of brain health and federal policy signals influence public perception and the broader climate for research participation. Catherine Gamble of Bristol Myers Squibb addressed the role of industry in shaping participant experiences and the importance of meaningful collaboration with advocacy organizations. Mallory Witham of Pillar Clinical Research highlighted how trust is built on the ground through respectful participant interactions, community outreach, and sustained engagement beyond individual studies.

Panelists also acknowledged a growing challenge: rising public skepticism toward medical science. When distrust narratives or misinformation circulate, clinical research sites often experience the operational impact directly—from longer enrollment conversations to increased hesitation among participants and caregivers.

Despite these challenges, the discussion emphasized that transparent communication, strong partnerships, and community-centered engagement can help rebuild confidence in evidence-based medicine.

As Fueling the Future February was winding down, this webinar reinforced a powerful message: advancing mental health research requires more than scientific discovery alone. It requires leadership, collaboration, and a shared commitment to building trust across the entire research ecosystem.

Brain Awareness Week Highlights the Importance of Brain Science

Each March, the global neuroscience community comes together to celebrate Brain Awareness Week, a campaign dedicated to fostering public enthusiasm for brain science and its impact on everyday life. Launched by The Dana Foundation, the initiative brings together universities, hospitals, research institutions, advocacy organizations, schools, and community groups to share discoveries about how the brain works and why continued research matters.

For the mental health clinical research community, Brain Awareness Week provides an opportunity to connect with the public and reinforce the importance of ongoing research and investment in neuroscience. By opening doors, sharing knowledge, and inviting curiosity, researchers and clinicians help build the trust and engagement that make scientific progress possible.

Clinical research sites, advocacy groups, and partners across the mental health ecosystem are encouraged to take part—whether by hosting an event, sharing educational resources, or simply helping amplify the message that brain research improves lives.

On March 30, the global mental health community observes World Bipolar Day, a day dedicated to raising awareness, reducing stigma, and highlighting the importance of continued research into bipolar disorder.

World Bipolar Day offers an opportunity for sites to engage their communities and highlight the importance of research participation.

Sites can mark the day by sharing educational resources about bipolar disorder, posting information about ongoing clinical trials, or hosting a brief “Research Awareness Day” for patients and community partners. Even simple actions—such as social media posts, patient education materials, or staff discussions about the importance of bipolar research—can help increase awareness and build trust.

By taking small steps to recognize World Bipolar Day, research sites can help amplify understanding, reduce stigma, and reinforce the critical role research plays in improving outcomes for individuals living with bipolar disorder.

Thank you for reading!

If you have questions, comments, or would like to submit an item to be included in an upcoming newsletter, please email erica@thestarr.org.