S&PAA Honored as STARR Advocate of the Year

The Schizophrenia & Psychosis Action Alliance (S&PAA) has been named the recipient of the prestigious STARR Advocate of the Year Award for their outstanding contributions to mental health advocacy. This honor celebrates S&PAA’s unwavering commitment to raising awareness, dismantling stigma, and supporting individuals living with schizophrenia and psychosis through groundbreaking initiatives and transformative efforts.

S&PAA’s achievements reflect a remarkable dedication to improving lives. Their legislative advocacy, spearheaded by Arun Nagendra, Ph.D, has driven critical policy reforms that amplify the voices of those affected by psychosis. Nicole Gillen’s development of practical and impactful toolkits has provided invaluable resources to individuals, families, and mental health professionals, fostering a deeper understanding of these conditions. Additionally, S&PAA’s focus on advancing research and promoting early diagnosis highlights their leadership in shaping a future of hope and better care for millions.

Accepting this well-deserved award on behalf of S&PAA is Gordon Lavigne, who has led the organization as CEO since 2020. His leadership embodies S&PAA’s vision of a world where all individuals affected by schizophrenia and psychosis have access to the understanding, care, and resources they need. The STARR Coalition proudly celebrates S&PAA as a trailblazer in mental health advocacy, honoring their exemplary impact and unwavering dedication.

Learn more about S&PAA and support this amazing organization HERE!

Call to Action to Engage in the CMS Public Submission Process for Austedo and Vraylar Medicare Price Negotiation

The Centers for Medicare and Medicaid Services (CMS) has invited public input to aid in its evaluation of Austedo and Vraylar as part of the Medicare Part D Drug Price Negotiation process.

This presents a crucial opportunity for mental health advocates, researchers, clinicians, patients, and caregivers to ensure that these medications - and all other mental health treatments - remain accessible and that the inclusion of mental health medications on the CMS negotiation list will be met with a powerful response.

Why This Matters

Austedo (deutetrabenazine) and Vraylar (cariprazine) are vital treatments for patients living with movement disorders, schizophrenia, and bipolar disorder. These medications help improve the quality of life for individuals managing conditions that significantly impact daily functioning. Medicare price negotiations may influence access, affordability, and availability of these medications, making it essential for those directly affected to contribute meaningful data and real-world experiences.

For Clinicians and Researchers: You bring expertise in the clinical effectiveness of these medications, their role in treatment plans, and their comparative value in mental health care. Your input can highlight the importance of continued access for Medicare beneficiaries and the consequences of potential cost barriers.

For Advocates and the Public: Ensuring continued mental health research into cures is a shared responsibility. By participating, you help reinforce the importance of continued research into new treatments for mental illnesses, that all options remain accessible, and that inclusion on the CMS negotiation list will be met with a powerful response.

For Patients and Caregivers: Your insights into the daily impact of these medications—how they improve symptoms, enable independence, and support well-being—are invaluable. Your testimony can illustrate why access to these treatments is not just a financial issue but a matter of maintaining stability and dignity in life.

How to Submit Your Input

The public submission portal can be accessed by requesting a link at https://hpms.cms.gov/app/ng/pblc_cmt/. Submissions can include personal experiences, research data, clinical perspectives, and any other information relevant to the evaluation of Austedo and Vraylar.

We Must Act Now—March 1, 2025, Deadline Approaching

This is a rare opportunity to influence policy decisions that could impact the most vulnerable among us. We encourage all members of the STARR community to lend your voices and ensure that not only do Austedo and Vraylar remain accessible for those who need them most, but also to send a message to CMS that including medications for mental illnesses will be met with a powerful response.

Every February, we honor the essential contributions of African Americans who have helped shape the nation. Black History Month celebrates the rich cultural heritage, triumphs and adversities that are an indelible part of our country's history.

The 2025 Black History Month theme, African Americans and Labor, focuses on the various and profound ways that work and working of all kinds – free and unfree, skilled, and unskilled, vocational and voluntary – intersect with the collective experiences of Black people.

As a black woman with experience in the clinical research industry as a recruiter and community outreach specialist for the past two years, I am proud to highlight the significance of clinical research as a healthcare option for individuals in my community.

It is crucial for the black community to be informed and educated about the growth and diversity seen in the clinical research industry since its early days. By fostering awareness and understanding, we empower our community to actively engage with and benefit from the advancements in research that are shaping the future of healthcare.

North Texas Clinical Trials is committed to addressing the unique mental health needs of the Black community through innovative research and culturally sensitive care. By collaborating with community leaders and ensuring representation in research. We aim to reduce stigma, promote awareness, and provide equitable mental health solutions.

February is Black History Month, a time to honor the contributions of Black individuals to various fields, including clinical research, and to explore the history of clinical research trials involving African Americans, which has been characterized by a legacy of unethical practices contributing to lasting mistrust and underrepresentation. While progress has been made, particularly in recent decades, continued efforts are needed to ensure ethical practices, enhance participation, and meet health disparities in medical research. Collaboration with underrepresented communities and transparency in research practices and communication are vital in improving health outcomes, restoring trust and addressing barriers such as mistrust, lack of access, and socioeconomic factors that may limit participation.

Historically, Black communities have faced significant disparities in healthcare, often being underrepresented in clinical trials. However, recent advancements are changing this narrative. Organizations and researchers are increasingly recognizing the importance of diversity in clinical trials to ensure that treatments are safe and effective for all populations, as people from different backgrounds may respond differently to medical products. Initiatives are being launched to enhance recruitment strategies, engage with underrepresented communities, and build trust through transparent communication regarding the research process.

Having attainable diversity goals among clinical trials helps to promote health equity advancements and bridge health disparities so that people in underserved communities can obtain access to the benefits of new treatments. As we celebrate Black History Month, it's essential to acknowledge these strides that have been made while committing to ongoing efforts for inclusivity and representation in clinical research, ensuring that public health is improving, and everyone's health needs are met.

Call for Sites: Please invite your patients with schizophrenia and their caregivers to participate in a 20–25 minute online survey to share their experiences and needs. Participants can opt to receive a $30 Amazon gift card for completing the survey.

All responses will be analyzed anonymously and will not be linked to personal information in any way. The goal of this study is to develop educational resources and other information for individuals affected by schizophrenia.

Download an info page to post at your site HERE.

Black Representation in Clinical Research: Progress and Challenges

The growing presence of Black and Brown professionals in clinical research—as both researchers and participants—marks a significant step toward more inclusive and effective medical advancements. Diversity in clinical trials ensures that treatments work for all populations, yet there is still work to be done.

One key challenge is increasing awareness and trust within Black communities. Community engagement through Black-owned research sites, trusted healthcare providers, and culturally competent outreach fosters confidence and encourages participation. When patients see researchers who reflect their backgrounds, it reinforces the importance of representation in medicine.

As a Black professional in clinical research, I feel a responsibility to encourage others—whether as researchers or as patients—to take an active role in shaping the future of medicine. Progress is happening, but we must continue pushing for inclusivity, trust, and equitable access to medical advancements. By continuing to build trust, increase representation, and educate communities, we can ensure equitable access to medical advancements for all.

J&J to buy psychiatric drug developer Intra-Cellular for $14.6B. Intra-Cellular's Caplyta is approved in the U.S. to treat schizophrenia and bipolar depression, and may be expanding to include major depressive disorder, which affects about 10 times as many people as schizophrenia and more than three times as many people as bipolar depression. The closing of the transaction is expected to occur later this year subject to applicable regulatory approvals, approval by Intra-Cellular Therapies’ stockholders and other customary closing conditions for a transaction of this type. 

FDA Approves the First Non-Opioid Pain Drug in 20 Years. Vertex announces the FDA approval of JOURNAVX™ (suzetrigine), a first-in-class treatment for adults with moderate-to-severe acute pain. This is the first and only approved non-opioid oral pain signal inhibitor and the first new class of pain medicine approved in more than 20 years and is shown to be effective and well-tolerated, without evidence of addictive potential. (PR here.)

J&J announced that the FDA approved SPRAVATO® (esketamine) CIII nasal spray, making this innovative treatment the first and only monotherapy for adults living with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants. Following U.S. FDA Priority Review, approval is based on data demonstrating SPRAVATO® alone met its primary endpoint at 4 weeks and led to rapid and superior improvement in depressive symptoms compared to placebo as early as 24 hours.

LB Pharmaceuticals Announces Positive Topline Results from Phase 2 Trial of LB-102 in Schizophrenia. These data highlight the potential of LB-102 to provide a new option for patients as a benzamide antipsychotic with favorable efficacy, safety and tolerability results and convenient once-daily dosing. The safety profile of the 50 mg dose creates an opportunity to explore other settings where typically lower doses of antipsychotics are indicated, such as for mood disorders and as a long-acting injectable formulation. LB Pharmaceuticals plans to engage with regulatory authorities to finalize Phase 3 trial design and expects to initiate the Phase 3 development program late this year or early next year.

Monument Therapeutics Announces Grant of Japanese Patent in Support of its MT1988 Cognitive Impairment Associated with Schizophrenia Program. The patent, which is expected to provide exclusivity until at least 2040, protects the use of a cognitive digital biomarker as a way to identify patients most likely to respond to Monument’s MT1988 compound for CIAS, and other pro-cognitive drug targets. 

Boehringer Ingelheim announced top-line results from the Phase III CONNEX clinical program in cognitive impairment in adults with schizophrenia, showing primary and key secondary endpoints were not met. The findings are disappointing, particularly given that cognitive impairment affects more than 80% of people with schizophrenia and there are no approved targeted pharmaceutical treatments for cognitive impairment. Boehringer Ingelheim's CONNEX program, the largest study of its kind, generated valuable data that will guide future research and innovation in this underserved area. Every setback in science is a stepping stone to future breakthroughs. We are grateful to Boehringer for pushing the boundaries of science to help all of those impacted by CIAS and look forward to future programs. 

Neurocrine announced the initiation of a phase 3 study to evaluate the efficacy, safety, and tolerability of osavampator, an investigational drug under development as an adjunctive treatment to antidepressants for major depressive disorder (MDD). Investigators will enroll adults with a primary diagnosis of MDD who have inadequate response to current, oral antidepressant treatment. Positive topline data for the Phase 2 SAVITRI™ study of osavampator in adult subjects with MDD were announced in April 2024.

Tris Pharma announced positive topline results from its ALLEVIATE-1 pivotal Phase 3 clinical trial evaluating cebranopadol for the treatment of moderate-to-severe acute pain in patients following abdominoplasty surgery. These results add to the growing body of data underscoring the promising efficacy and safety profile of cebranopadol, a first-in-class pain therapy involving dual-nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor (dual-NMR) agonism. This dual-NMR agonist has the potential to deliver significant pain relief comparable to opioids with minimized risk of significant side effects, dependence, or addiction.

Dionysus Digital Health has secured a second Dept of Defense grant of $4M to propel the development of a user-friendly, saliva-based test for predicting postpartum depression risk. The Enlighten Test is an epigenetic test taken during pregnancy that predicts future postpartum depression risk. Having a biological test showing any elevated risk to PPD will help women recognize PPD symptoms if they develop.

Scientists pinpoint neural marker for schizophrenia-related cognitive challenges. A recent study in the journal Cell Reports Medicine 00549-4)has highlighted a brain network involved in cognitive challenges faced by people with schizophrenia. Building on insights from animal research, scientists identified that difficulties with tasks requiring attention to conflicting information are linked to weak communication between two key brain areas. This discovery introduces a potential biological marker for assessing cognitive function and tracking treatment progress in schizophrenia.

Stanford Medicine scientists are generating a periodic table of sorts for psychiatric disorders, providing better understanding of these conditions and paving the way toward targeted treatment. By combining two massive, publicly available databases – one flagging genes associated with psychiatric disorders, the other showing which cells in which parts of the human brain are making the most use of which of our genes – they’ve implicated certain cell types, located in particular brain regions, in schizophrenia.

An international team of researchers has pinpointed 36 genes linked to bipolar disorder in the largest study conducted to date on the biological mechanisms underlying the condition. The findings could potentially help doctors intervene early and better diagnose and treat individuals at risk. The findings also identified 298 genomic regions—specific locations in our DNA sequence—associated with bipolar disorder, of which 267 are newly discovered. Roughly 158,000 individuals with bipolar disorder and 2.8 million healthy individuals worldwide participated in the study. 

Adial Pharmaceuticals announced the completion of a study of AD04, an investigational selective serotonin-3 receptor (5-HT3) antagonist being developed for the treatment of alcohol use disorder (AUD) in patients with a 5-HT3 genomic biomarker. These study results support the near micro-dosing regimen planned for use in the upcoming registration trials for AD04 and make up the regulatory submission for the FDA.

Beckley Psytech today announced positive topline results from their open-label phase 2A study of BPL-003 in participants with moderate-to-severe alcohol use disorder (AUD), which show that treatment with BPL-003 can induce meaningful and sustained reductions in alcohol use and heavy drinking days (HDDs) for up to 3 months following a single dose.

The Center on integrated health care ​& self-directed recovery (located in the Department of Psychiatry of the University of Illinois at Chicago) released the latest certified peer specialist numbers. With a total of 100,000 certified peer specialists in 49 states and the District of Columbia (DC). Moreover, 47 states and DC also fund at least some of their peer services using Medicaid dollars. The Center offers a very cool interactive map with information on each state.

The Federal Trade Commission (FTC) on January 14 released its second report on pharmacy benefit managers (PBMs), this time alleging the companies marked up prices for cancer, HIV, and other medications by up to “thousands of percent.” The findings are part of the agency’s multiyear investigation into PBMs that began in 2022. The report focuses on the three largest PBMs in the US—CVS Health’s CVS Caremark, Cigna’s Express Scripts, and UnitedHealth Group’s Optum Rx—and how they influenced the prices of specialty generic medicines.

Crisis services struggle to meet increased need generated from 988 calls. The 988 hotline launch led to a minor increase in peer support services but decreased psychiatric walk-in services and other crisis services. Public facilities were more likely to offer crisis services compared to for-profit facilities, which had the most limited services. State-level variations showed some states increased peer support services, while others saw declines in suicide prevention services.

In 2022, 27.6% of Broward County's population was Black or African American; neighboring Miami-Dade County is about 15% Black/African American. Right in the heart of these communities is CenExel-Florida (RCA).

For Black History Month, Cecily Hernández, Community Partnership Manager at CenExel-Florida met with 4 current black participants to talk about their experience with clinical research.

Mr. T (45 years old male):

• What made you get involved on mental health research? "In the beginning, I was worried, trying to find out how to feel better."
• How beneficial has research been? "The drugs helped me, the information and the staff."
• What barriers have you encountered? "I am not a people's person. It is difficult to succeed. After research I feel more open, more freely, more confident."
• What do you think about mental health research? "Research is good. People don't do it because they don't know what research is about. Education is very important; it is a good thing. I would do it again."

Mr. M (35 years old and has participated in more than one trial):

• Would you recommend research to a friend? "I would recommend research to a friend. They are a little hesitant, there are a lot of stigmas. They have to come and they have to listen in detail to know what is about.
• How has research helped you? "There are certain shots that helped me. I hate to go back to my regular medicine."
• How has research been for you? "It has been a good and positive experience."

Mr. F (44 years old who had schizophrenia since he was 13 years old):

• What would you tell others in your community about research? "It is good to be financially better, especially for someone with my mental health condition. It will help other people looking for help. They will get knowledge from me. What they can learn here, it will help people around. In my family, they were not aware. If you need a little change, if you need self-control and a little money, you should try research. It is good to have the extra change. You are helping yourself. "

Mr. K (25 years old):

• What can you tell us about your experience being part of a clinical trial? "It has helped me with family and money".
• Where did you find out about research? I heard about research in the hospital. I didn't know anything about research before. 
• What does your friend say if they knew that you participated in a trial? "They would say that I was a guinea pig, but I would tell them how good and better I feel. I would recommend it to my friends."

Education and trust-building are essential to increasing Black community participation in mental health clinical research. Conversations with community members consistently highlight a significant gap in knowledge about the safety, benefits, and purpose of clinical research—particularly in mental health. This lack of awareness, coupled with historical and systemic mistrust, reinforces hesitancy and limits engagement. Addressing these concerns through culturally competent education and transparent communication is crucial to building trust and ensuring equitable access to mental health research as a viable care option.

Register now for S&PAA's Innovations in Treatment Webinar Series 'Understanding the Cognitive Impact of Schizophrenia' on Feb. 27th at 11:30am ET. The series takes a fresh approach by presenting diagnosed people’s perspectives side by side with those of clinicians and caregivers – providing strategies and insights in a more interactive environment outside of the doctor’s office.

If you missed the first two episodes in the series, you can check them out HERE.

The latest from

The Family Peer Support Services Fact Sheet, created in collaboration with SAMSHA was just released, offering considerations and recommendation for expanding family peer support services to include all family members as more siblings, spouses, adult children, and others step into a caregiving role for their loved ones with mental health and/or substance use challenges. Find the 17-page Fact Sheet HERE.

NFSTAC Family Connections Webinar: 988 & 911 – What to Know, What to Do: Feb 6th, 1:30pm ET

If you're concerned about supporting another person experiencing mental health and/or substance use challenges or about your own wellbeing, it's important to feel confident about getting the right support when you need it. We'll focus on the differences between 988 and 911, dispel myths about 988, and discuss your questions about responding to crisis.

Family Collective's second Episode: Supporting Fathers as Caregivers - Podcast available now!

Family Collective's second episode 'Supporting Fathers as Caregivers' features Chief Visionary Officer for the Commonwealth Center for Fathers and Families, David Cozart, discussing how he fosters out-of-the-box thinking to ensure fathers are included as full partners within a child’s life and as caregivers of their children.

BMC Psychiatry is recruiting new Editorial Board Members.

BMC Psychiatry is an open access, peer-reviewed journal that encompasses a wide range of topics, including psychopharmacology, psychotherapy, and psychosocial approaches to psychiatric disorders, as well as genetics, pathophysiology, and epidemiology research.

Find more info here.

February 24 - March 1, 2025 is BrainHealth Week!

Join our friends in Texas for the annual five-day event that offers daily science-based tools to inspire brain-healthy habits that can be incorporated into our daily lives.

The events might be in Texas, but we can all benefit from the tips and tools!

 Sign up for the updates and challenges HERE!

The ASENT 2025 Annual Meeting will take place March 12 - 14, 2025 at the Hyatt Regency Bethesda in Bethesda, MD. Join leaders from payers, providers, investors, fast-growing startups, pharma, policymakers, funders, and innovation centers to gather with one central focus: improving the process of bringing neurotherapeutics to market. For info and to register, click here.

Join the Anxiety and Depression Association of America for their annual meeting on April 3rd - 5th, 2025 in Las Vegas. Join us for a dynamic exploration of research findings and clinical solutions, as we work towards building a brighter future for our youth.

Mark your calendar! Join us May 14-15 in Washington, D.C., for S&PAA's 2nd annual SPRING Summit! We’ll bring together people with schizophrenia, caregivers, clinicians, researchers and others for two days of panel sessions, workshops and collaboration as we continue to activate our Roadmap to Recovery. Join us at the only forum specifically dedicated to the needs of the schizophrenia community and designed to identify actionable solutions. Click here to sign up to receive the invitation with the full agenda, reception info, speakers and a registration link. We can’t wait to see you in May!

The 2025 ASCP Annual Meeting will be held May 27-30 2025 at the Fairmont Scottsdale Princess Hotel in Scottsdale, Arizona. This year's theme is 'Navigating the Evolution of Clinical Psychiatry: When is Newer Better?' The Late-Breaking Posters submission deadline is March 28, 2025. More info on 2025 ASCP Annual Meeting here.

At NAMICon 2025, we’re meeting you where you are—whether at home, at work, or on your unique mental health journey. Held virtually from June 11-13, this year’s conference is your chance to connect, inspire, and drive meaningful change. The 2025 Call for Proposals is Open! Share your story, experiences, and transformative ideas to inspire and empower a diverse audience. Whether through personal insights or innovative research, your voice has the power to challenge perspectives and drive change in mental health. More information and to submit a proposal here.

Save the Date: Mental Health America 2025 Conference, will be held October 16-17 in Washington D.C. Details coming soon. The 2025 Call for Proposals is open. For more information and to submit a proposal, click here.

DBSA Partnership Opportunities

DBSA relies on partners to ensure that people living with mood disorders continue to have access to online and in-person peer support groups, peer specialist training, and life-saving education. Your support also enables DBSA to continue its local, state, and national advocacy efforts, placing peer voices at the forefront when determining needs and best practices for mental health services.

In 2025, DBSA is celebrating the last 40 years and will look to the future with several key events and educational and awareness activities. Your sponsorship will enable these celebratory activities to occur and provide programmatic support to DBSA.

Please click here to view our 40th Anniversary Sponsorship Opportunities.

AFSP has released their public policy and advocacy priorities for 2025-2026

Download the AFSP Report

The following four overarching pillars will guide AFSP’s public policy and advocacy priorities:

1. Services and Care
2. Lethal Means Safety
3. Research and Infrastructure
4. Disproportionately Affected Communities and Populations

Within each of the four pillars, AFSP targets upstream prevention, early intervention, treatment and recovery policies. The solutions set forth aim to reduce suicidal thoughts, prevent suicide attempts and deaths, promote healing, and provide care and support for those who have lost loved ones to suicide.

The report is intended to be used by advocates, partners, and public officials at all levels of government as a resource for identifying policy opportunities to better promote suicide prevention and improve mental health.

The Harley Jacobsen Clinical Trial Participation Income Exemption Act seeks to exclude all payments to participants in clinical trials from being treated as taxable income so welfare benefits are not put at risk.



WHAT CAN YOU DO TO SUPPORT THIS IMPORTANT LEGISLATION?

1. Sign the petition on Change.org to show your support for the Harley Jacobsen Act. Share the petition with your network and colleagues.

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2.  Sign on the Mural Health website, supporting the Harley Jacobsen Act.

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.