Honoring the Changemakers Advancing Mental Health Research: The 2025 STARR Award Winners

The 2025 STARR Awards Celebration, held virtually on December 18, recognized the individuals and organizations helping move mental health research and advocacy forward when it matters most. Hosted by Adam Simmons, the event honored leadership that builds trust, strengthens community engagement, and brings researchers, advocates, and people with lived experience together to create meaningful, lasting change.

This year’s award recipients exemplify the dedication and collaboration needed to drive meaningful progress:

Advocate of the Year Award: Students With Psychosis

Site of the Year Award: Trialmed Atlanta

Sponsor of the Year Award: Boehringer Ingelheim

Lew Yagodnik Award: Shishuka Malhotra, MD, Founder of Neuro-Behavioral 
 Research & The Ohio Center for Hope

Each awardee has made a lasting impact -- advancing new treatments, breaking down stigma, and elevating awareness of the critical role clinical research plays in improving mental health care.

In the coming months, we’ll spotlight each honoree in the STARR newsletter, sharing their stories and the work that continues to inspire progress across our community.

Congratulations to our 2025 STARR Award winners on these well-deserved honors! 💚

As we step into 2026, many of us feel that familiar nudge to set big goals, make bold resolutions, and transform our lives overnight. But this year, maybe there’s a gentler, wiser invitation waiting for us — one rooted not in pressure, but in possibility.

Instead of choosing a single New Year’s resolution that’s destined to fade by February, consider choosing a focus word for the year — something that captures who you want to become and how you want to live. My word for 2026 is RELENTLESS. Not in the sense of being harsh or unyielding, but in the spirit of persistent, steady pursuit. Relentless in my effort. Relentless in my belief in what’s possible. Relentless in showing up for the work that matters.

Another option for shaping your year is trying what's called '12 Tiny Experiments' — a simple practice where you explore one small, low-stakes experiment each month focused on fun, creativity, relationships, or learning. Nothing expensive, nothing overwhelming. Each experiment can be started in under two hours and for under $50, but the impact can ripple far beyond its size. Think of these as playful tests in what brings you joy, clarity, or momentum—with no failure possible, only information. Check our website for our list and the prompt to help you create your own list.

Or maybe your path looks different: reconnecting with someone you miss, taking better care of your mental health, finding small ways to contribute to your community, or simply allowing more rest and reflection. Whatever shape your intention takes, the goal is the same: to build a year rooted in good health, good work, and genuine goodness — toward ourselves and toward one another.

So here’s to 2026. A year where we choose possibility over pressure, experiments over expectations, and relentless hope over everything else.

Let’s make it a good one. ❤

Teva Pharmaceuticals has submitted a NDA to the FDA for olanzapine extended-release injectable suspension (TEV-'749) for the treatment of adults with schizophrenia. The NDA for olanzapine LAI is based on results from the successful phase 3 SOLARIS trial, including week 56 results studying its efficacy, safety, and tolerability in participants aged 18 to 64 with schizophrenia.

Cobenfy for treatment of schizophrenia has been approved in China. The approval was supported by data from a phase 1 pharmacokinetics study in China, a phase 3 study in China, and 3 global EMERGENT studies. The phase 3 study in China was a multicenter, 2-part study with a 5 week double-blind, randomized, placebo-controlled phase and a 12 week open-label extension phase. Cobenfy has been approved in the US for about a year.

BMS identified irregularities in ADEPT-2 trial data, leading to data exclusion and FDA consultation for an independent interim analysis. BMS will enroll additional patients in the ADEPT-2 study—a phase 3, multicenter, randomized, double-blind, placebo-controlled trial assessing the safety and efficacy of xanomeline/trospium (Cobenfy) in participants with psychosis associated with Alzheimer disease dementia, based on the Data Monitoring Committee's recommendation.

Newron Pharmaceuticals announced the initiation of its ENIGMA-TRS2 phase 3 clinical study in the US, following approvals from the FDA and IRB. ENIGMA-TRS 2 is a phase 3, 12-week, randomized, double-blind, placebo-controlled trial evaluating the efficacy, safety, and tolerability of evenamide 15 mg twice daily as an add-on therapy to current antipsychotics, including clozapine, compared with placebo, in patients with treatment-resistant schizophrenia (TRS). 

Syremis Therapeutics announced programs for ST-905 and ST-901, 2 new drugs in schizophrenia and major depressive disorder, respectively. Syremis plans the lead program for ST-905, a dual M1/M4 muscarinic agonist in development for schizophrenia and other conditions. ST-905 research is currently in phase 1. Another program for ST-901, for the novel NMDA receptor antagonist, will advance. The drug is currently in studies that will enable an IND application. ST-901 research is intended for treatment of major depressive disorder and bipolar depression.

Meta-analysis identifies 2 antidepressants that separate from placebo and other antidepressants in relieving negative symptoms of schizophrenia. Of the antidepressants which have been trialed as adjuncts to antipsychotics in reducing negative symptoms of schizophrenia, mirtazapine and duloxetine appear significantly better than placebo (with mirtazapine superior to several other antidepressants) in a recent systematic review and network meta-analysis.

The FDA recommended a second phase 3 trial for Reviva Pharmaceuticals' brilaroxazine for patients with schizophrenia to “generate additional efficacy data and expand the safety dataset." Reviva is developing the novel serotonin-dopamine and neuroinflammatory signaling modulator to treat schizophrenia. Pending financing, Reviva plans to initiate the RECOVER-2 trial in the first half of 2026; the phase 3 trial will be similar to the RECOVER phase 3 trial, although the FDA shared guidance with the company on “methods of data analysis, methods of data presentation, and data requirements for studies of animal pharmacokinetics, human abuse potential, and renal and hepatic impairment.”

Vistagen's fasedienol failsed to show significant efficacy in treating social anxiety disorder, despite favorable safety data from the PALISADE-3 trial. The PALISADE-3 phase 3 trial was a multicenter, randomized, double-blind, placebo-controlled study evaluating efficacy and safety of single dose fasedienol. Intranasal administration of fasedienol was intended to reduce anxiety symptoms during a simulated public speaking challenge.

SciNeuro secures $53M to advance its neurodegeneration pipeline, adding further momentum to an already vibrant era in brain health innovation. The financing—led by Arch and Lilly Asia Ventures—will support programs targeting key mechanisms implicated in Alzheimer’s, Parkinson’s, and related disorders. While modest compared to recent mega-deals in the space, the raise reflects steady investor confidence in next-generation neuroscience platforms and continued enthusiasm for translating emerging biology into meaningful therapeutic options.

Compass Pathways announced that the FDA has accepted its Investigational New Drug application for COMP360 for PTSD, enabling a late-stage Phase 2b/3 clinical trial. The decision marks a significant milestone for psychedelic-assisted mental health research, advancing a potential new treatment option amid substantial unmet need for PTSD and treatment-resistant depression.

A 1-week social media (SM) detox intervention among young adults was associated with reductions of 25%, 16%, and 15% in symptoms of depression, anxiety, and insomnia, respectively, in a new prospective cohort study. Mean daily SM screen time decreased from a mean of 1.9 hours at baseline to 0.5 hours during the detox period. Significant reductions from baseline occurred after the SM detox in symptoms of depression, anxiety, and insomnia

Following a legal settlement, the NIH will re-review hundreds of grant proposals that were frozen, denied, or withdrawn earlier this year due to Trump-era directives targeting research areas such as transgender health and DEI. NIH has agreed to evaluate applications “in good faith” using its standard processes and within set deadlines—offering a partial path forward for researchers, even as concerns remain about political interference and long-term impacts on scientific progress.

The FDA aims to streamline biosimilar drug development, announcing new efforts to reduce redundancy, clarify approval pathways, and accelerate access to lower-cost alternatives. Updated guidance will emphasize more targeted clinical studies, expanded use of advanced analytics, and clearer expectations for demonstrating biosimilarity. These changes could shape future trial design and regulatory strategy across therapeutic areas, creating opportunities for more efficient development timelines and greater affordability of biologic treatments. The draft guidance aimed at speeding up biosimilar drug development was officially published on November 20, 2025, and comments will be accepted until January 20, 2026.

We join our colleagues at The American Brain Coalition in their concern over the sudden departure of Dr. Walter Koroshetz as Director of NINDS after nearly 20 years of impactful leadership. ABC has published a statement urging NIH to ensure stability and continued progress in brain research. Read more on ABC's position and why this matters to the community.

Thank you, NAMI NYS, for promoting the STARR Stop the Stigma Champion Award!

The STARR Coalition is currently seeking nominations for its inspiring Stop the Stigma Champion Award, an initiative designed to empower high school students to lead the way in mental health advocacy.

This is a unique opportunity for young people to become visible leaders in their communities, helping to break down the stigma surrounding mental illness and promote open, supportive conversations about mental health.

If you know a student who is passionate about mental health, empathetic, and ready to make a difference, we encourage you to nominate them today.

The new episode of the NAMI NYS Next Gen Podcast is out now!

In this inspiring episode, host Taylor Locke speaks with Victoria Treadwell — a University at Albany student, certified surgical technologist, pilot trainee, marathon runner, and 2023 Miss New York State for America Strong.

As an overdose survivor and passionate advocate, Victoria opens up about her journey of resilience, recovery, and breaking the stigma around substance use disorder.

🎧 Tune in now to hear her powerful story of hope and determination!

If you’ve been on social media lately, you’ll notice more and more mental health professionals sharing advice. And while much of it is helpful, it raises an important question: where’s the line between content and care? 

In this episode of AFSP's Strong Talk, Vic sits down with Shani Tran, a licensed professional clinical counselor, author, and content creator, to explore this phenomenon. In their conversation, Shani shares how she started posting on social media, the significant boundaries between her real and online self, and why none of the mental health content on social media counts as therapy.

To learn more about AFSP, visit afsp.org and to check out the podcasts HERE.

Leadership Transition at DBSA

Michael Pollock has announced that he will step down as CEO of the Depression and Bipolar Support Alliance (DBSA) after more than seven years of dedicated leadership. The STARR community extends our sincere gratitude for his service and impact.

Beginning January 1, 2026, Suzanne Baber, LCSW, DBSA’s Director of Peer Support Services, will serve as Interim CEO. With more than 15 years of nonprofit experience in finance, fundraising, and program development, Suzanne steps into the role with full support from the Board.

This transition comes as DBSA concludes its 40th anniversary and prepares to launch a new strategic plan focused on elevating peer support as an essential part of mental health care—strengthening the organization’s ability to grow partnerships, funding, and community impact. ✻

The Subtle Art of Research Rapport: 
Clinical Raters and Trial Integrity

Clinical Assessment Specialists, aka raters, sit at one of the most delicate intersections in mental health research: creating enough rapport for honest disclosure while maintaining the objectivity essential for high-quality data. As highlighted in Dr. Vamshi Gurrala’s article, "Challenges Facing Clinical Assessment Specialists at Mental Health Research Sites", this balance is far more nuanced than it appears. Raters often enter studies with rich clinical backgrounds, yet the instincts that serve them well in therapeutic settings can introduce bias in research environments.

In trials where small shifts in symptom ratings can influence endpoints, reimbursement decisions, and future access to care, the distinction between research rapport and therapeutic rapport becomes mission-critical. Over-identification, subtle reassurance, or emotional over-engagement can unintentionally elevate placebo response or distort symptom reporting — an issue every research leader has encountered across programs and indications.



As our field advances, supporting raters with ongoing training, reflective practice, and operational guardrails will remain essential. You can read Dr. Gurrala's full article HERE.

Happy New Year, STARR Community!

As we step into 2026, our hearts are full of gratitude for this extraordinary community - research teams, volunteers, advocates, sponsors, families, and every person who believes that mental health research can light the way toward a better future.

This year, we’re not just turning a calendar page.

We’re turning up the volume.

On connection.

On compassion.

On collaboration.

On the relentless pursuit of hope through science.

The work ahead is big, but so is our collective power. Every conversation you start, every volunteer you support, every partnership you strengthen moves us closer to a world where mental health research is trusted, accessible, and embraced as a vital part of care.

Here’s to a year of bold ideas, shared purpose, and continued kindness.

From all of us at The STARR Coalition: Happy New Year!

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.