STARR News & Updates

October 2024

October is National Depression Education & Awareness Month, a time to spread awareness and education of the signs, symptoms, and treatment options for depression.

 

During 2020, 18.4% of U.S. adults reported having ever been diagnosed with depression. Depression is the cause of over two-thirds of the 30,000 reported suicides in the U.S. each year (https://www.dbsalliance.org/education/depression/statistics/) and a major contributor to mortality, morbidity, disability, and economic costs in the United States (https://www.cdc.gov/mmwr/volumes/72/wr/mm7224a1.htm).


The month of October is filled with mental health awareness events, sharing of information and education on mental health illnesses, screenings, and prevention. The following are observed throughout October (with links to details):

 Observed focus weeks throughout October are: 

Observed focus days include:

Mental Health Awareness Week & World Mental Health Day

This year, alongside the World Federation for Mental Health, the founders of World Mental Health Day, NAMI is recognizing the importance of prioritizing mental health in the workplace. This year's theme for Mental Illness Awareness Week and World Mental Health Day is “My Mental Health at Work.” NAMI has created graphics and sample captions designed to help you spread the word about My Mental Health at Work during this Mental Illness Awareness Week - check them out HERE.

The CenExel RCA team joined forces with NAMI Broward during their community conversation "Compartiendo Esperanza" event in September. This NAMI program was created for Hispanic/ Latin American communities to discuss mental health and wellness. It was a great opportunity to break the stigma surrounding mental health in the Latin-American community and promote a culture of understanding and empathy. CenExel RCA provided information on the latest research and current mental health trials available to the participants.

CenExel RCA was also on hand to support the U.S. Department of Veterans Affairs and the Miami VA Healthcare System "Suicide Prevention Mental Health Summit" to raise awareness during the Suicide Prevention Month. The event provided training and discussions to assist in raising awareness of suicide prevention and share that help is available and suicide can be prevented. CenExel RCA joined the Miami VA System Suicide Prevention team in their efforts of community education. As presented, sadly we all have been connected to someone that has committed suicide. (Pictured: Cecily Hernandez with Jose Baez)

Richmond Behavioral Associates, part of the ERG group, in collaboration with CABS Health Network held a workshop at the Glenwood Senior Center in Brooklyn, New York. The focus of the conference was to engage seniors in the community by building their confidence in managing Dementia. Dr. Adam Smith of RBA discussed various forms of dementia and effective strategies for medication management. The audience consisted of members of the senior center who were mainly New York City Housing Authority residents. RBA provided free memory exams during and after the workshop.

Midwest Clinical Research Center, part of the ERG group, in Dayton, Ohio, were proud to sponsor, volunteer, and walk the Montgomery County NAMI Walk! It was an amazing day of coming together for #mentalhealthforall! NAMI Montgomery County Ohio serves their community with free mental health support, online groups, resources and education.


Kudos to the team at Midwest Clinical Research for walking the Walk! 💚💙

Neuro-Behavioral Clinical Research and the Ohio Center for Hope hosted a successful Memory Day and Senior Resource Fair in September at the Firestone Park Community Center. The event aimed to emphasize the critical importance of early memory loss detection, provide valuable information for those experiencing memory issues, and showcase available support services.


The event's success was made possible by the generous support of the vendors from across the region. Free memory screenings, informative resources, door prizes, and giveaways contributed to making the day truly memorable.

Pillar Clinical Research supported the Chicago AFSP at the Out of the Darkness Walk! Members of the Chicago team of Pillar Clinical Research took part in the Chicago American Foundation for Suicide Prevention (AFSP) Out of the Darkness Walk last month. The team was led by Gabby Cordova. From left to right, that’s Caprice, Anna, Dre, Robert, Gabby, and Kurt. The walk raised over $790,000 for suicide prevention resources in the Chicago area. It was a gorgeous day and a great turn-out for the annual event! 

And in other exciting Pillar Clinical Research news, Bruce Trimble, Pillar's Chief Experience Officer, was elected to the NAMI-TX board of directors, as the director-at-large of area three. NAMI Texas has 25 local affiliates throughout Texas, with nearly 2,000 members made up of individuals living with mental illness, family members, friends, and professionals. Its purpose is to help improve the lives of people affected by mental illness through education, support, and advocacy. “Given the mission of NAMI and the impact that Texas NAMI continues to make for the benefit of Texans, I am honored to be elected to this position,” said Bruce. “Executive Director of Texas NAMI, Greg Hansch, and his team have established some key initiatives and I am looking forward to assisting in reaching our goals.” 

Call for Nominations for 2024 STARR Awards!


The STARR Coalition is excited to announce the call for nominations for the prestigious 2024 STARR Awards! The STARR Awards shine a spotlight on the tireless advocates, researchers, and organizations that work passionately to create positive change in the mental health space. As part of the STARR Coalition’s mission to support mental health clinical research, these awards serve as a symbol of gratitude and recognition for those who are helping lead the way toward a future of greater mental health understanding, acceptance, and treatment.


We are proud to honor individuals and groups who have gone above and beyond in the following categories:

  • STARR Advocate of the Year: This recognition is given to the advocacy organization that has demonstrated exceptional dedication to advocating on behalf of those living with mental illnesses, their efforts to fight the stigma of mental illness, and their support of the STARR Coalition’s collective efforts to support mental health clinical research.
  • STARR Site of the Year: A recognition that celebrates one site's outstanding commitment to patient care and community engagement.
  • STARR Sponsor of the Year: Recognizing a pharmaceutical or drug development company for their work supporting mental health research and advocacy, and for their continued support of individuals living with mental illnesses and their patient advocacy organizations. 
  • STARR Lew Yagodnik Award: The ‘Lewie’ is the only STARR award given to an individual that exemplifies leadership, compassion, and commitment to the mental health community and who has distinguished themselves in their exceptional dedication to those living with mental illness.

As we look toward 2024, we also want to once more congratulate the winners of the 2023 STARR Awards, who have inspired so many with their achievements:

  • Karuna Therapeutics: STARR Sponsor of the Year
  • Rural Minds: STARR Advocate of the Year
  • North Texas Clinical Trials (NTXCT): STARR Site of the Year
  • Michelle Roberts: STARR Lew Yagodnik Award

We invite the STARR community to nominate those who continue to fight for a better world for those living with mental health conditions. Nominations for the 2024 STARR Awards are now open, and we look forward to receiving your submissions!

At the Congressional Black Caucus Foundation's Annual Legislative Conference in Washington this month, S&PAA’s Dr. Arun Nagendra spotlighted the barriers to care faced every day by people of color with schizophrenia. They experience more stigma and discrimination, are more likely to be misdiagnosed and are less likely to receive newer antipsychotic medicines when they suffer psychosis.  

To compound the problem, a rule in the Inflation Reduction Act threatens to stifle innovation in the type of medicines most common for treating schizophrenia (known as small-molecule drugs), according to Dr. Nagendra, who spoke as part of a panel discussion about policies that pose particular risk to communities of color. “This could reduce the availability of essential treatments for schizophrenia, while exacerbating health disparities for low-income and minority populations,” she warned during her presentation. 



The Inflation Reduction Act has already had a heavy impact on small-molecule new molecular entities (NMEs) vs. biologics in new clinical trials (noting that the NMEs are critical to psychiatric treatments). The table shown is pulled from clinicaltrials.gov (thanks to Candace DeMatteis for sharing it). It shows that new small molecule trials (in yellow) have almost stopped, while biologics (blue) have taken over the funnel.


This is directly related to the IRA bill, since the law penalizes development of small molecule drugs by setting a shorter, 9-year post-approval window before their “fair prices” are implemented. According to a Forbes article*, "several drug companies have publicly stated that they’re terminating a number of small molecule drugs from their pipeline. In addition, the trade group PhRMA said that in a survey it conducted 63% of member companies expect to shift at least some of their research and development investment away from small molecule medicines."


Stayed tuned - it may be a bumpy ride.

During this year’s NAMICon, the Teva team hosted a special roundtable discussion with a panel of 5 incredible spokespeople who understand what it is like to live with schizophrenia, the impact it can have on one’s wellbeing, and current schizophrenia treatment options available. The discussion shares lived experiences and aims to reduce stigma around schizophrenia as well as provide a sense of hope for the community that they can overcome challenges despite this condition.


The 5 panelists included:

  • Matt Shapiro (moderator) – Senior Director of Government & Community Affairs for the National Alliance on Mental Illness-New York State (NAMI-NYS)
  • Carlos Larrauri – A diagnosed schizophrenia patient, law student and former NAMI board member
  • Monica Kumar – Caregiver to Carlos and psychiatry resident
  • Jacqui Jordan – A nurse practitioner in Colorado specializing in care for schizophrenia patients
  • Michelle Roberts, Senior Director of Patient Advocacy & Medical Affairs at Teva Pharmaceuticals

On Thursday, October 10th at 2pm ET, Teva will broadcast the roundtable on Facebook Live in celebration of World Mental Health Day.


Join us for this special event focused the real-life stories, information, and insights from people that live and work with schizophrenia on a daily basis.


RSVP on Facebook here.

In the inaugural Let's Talk About It podcast from The STARR Coalition, the winners of the 2023 and 2024 Stop the Stigma Champions and their parents sit down with host Leslie Franceschi to talk about their mental health advocacy journey. Megan and Max talk about their advocacy before receiving the STARR's Stop the Stigma Champion Award, as well as what they have been working on since.


Megan and Max's stories serve to inspire other youth in advocacy to speak out about mental health, break the stigma around mental illness, and generally to be good humans in their local communities. No edits have been made to this podcast - you are seeing it in it's 'Raw' form. 

The FDA has approved Karuna/Bristol Myers Squibb’s KarXT (Cobenfy) — the first schizophrenia drug with new mechanism of action since the '50s. Researchers are now working to add muscarinic agonists to existing dopaminergic drug regimens, in the hopes of efficacy gains for the 75–80% of patients who currently have inadequately managed symptoms of schizophrenia. A phase III study of adjunctive KarXT is ongoing, with a top-line readout anticipated early in 2025. 

Segal Trials, based in South Florida, contributed to the FDA approval of COBENFY™ , an oral medication for treating schizophrenia in adults. The approval of Cobenfy marks a significant advancement in schizophrenia treatment, being the first of its kind approved for this condition in 35 years, since the approval of Clozaril (clozapine). “This achievement holds special significance for Segal Trials, as we’ve dedicated over 25 years to advancing schizophrenia research through leading Phase I-III outpatient and inpatient trials,” said Bonnie Segal, President of Segal Trials. “Dr. Kakar and our other investigators have conducted nearly 500 trials, contributing to multiple FDA approvals, and we remain committed to pushing the boundaries of innovation in mental health treatment.”


TEV-‘749 demonstrates no incidence of postinjection delirium/sedation syndrome in new data. Teva Pharmaceuticals shared new positive efficacy, safety, and tolerability results from the phase 3 subcutaneous olanzapine extended-release injection study (SOLARIS) trial evaluating TEV-‘749 in adult patients diagnosed with schizophrenia. TEV-‘749 is an investigational once-monthly subcutaneous long-acting injectable (LAI) that steadily releases olanzapine—the most prescribed second generation antipsychotic for schizophrenia in the US—via SteadyTeq, which is a copolymer technology proprietary to Medincell.


Neurocrine Biosciences announced that it will no longer push through with the development of their schizophrenia candidate luvadaxistat after its disappointing mid-stage performance. We reported last month that Neurocrine's schizophrenia candidate, dubbed NBI-1117568 improved symptoms of the psychiatric disorder in a Phase II trial, but only at the lowest dose tested, while all other doses failed to meet the study’s primary endpoint.


Meanwhile in Austalia, the first synaptic regenerative therapy for Schizophrenia is being investigated.  Spinogenix recently announced that multiple sites are enrolling participants in a phase 2 clinical trial to evaluate SPG302, the first synaptic regenerative therapy for schizophrenia, with the approval of the Australia Human Research Ethics Committee. SPG302 focuses on addressing a key feature of schizophrenia that may contribute to all symptom domains: a loss of glutamatergic synapses (Additional information on the Phase 2 trial is available on ClinicalTrials.gov (NCT06442462).


First Digital Treatment for Generalized Anxiety Disorder Cleared by the FDA. Big Health’s DaylightRx is a prescription digital therapeutic that delivers cognitive behavioral therapy to treat generalized anxiety disorder (GAD) in patients aged 22 and older. DaylightRx is the very first FDA-cleared digital treatment for GAD. This digital therapeutic can be ordered by a licensed health care provider and is meant to be an adjunct to usual care.


Slow-Release Oral Ketamine Formulations Show Promise for At-Home Treatment of Resistant Depression. Douglas Pharmaceuticals' Phase 2 trial data suggest extended-release oral ketamine formulations could provide antidepressant efficacy for patients with treatment-resistant depression (TRD), without the requirement for parenteral administration, or the degree of dissociative adverse effects associated with injectable ketamine and intranasal esketamine.


Teva's Deutetrabenazine Shows Long Term Efficacy and Safety in Patients with Tardive Dyskinesia. A new analysis from the European cohort of the Reducing Involuntary Movements in Participants with Tardive Dyskinesia (RIM-TD) open-label extension study revealed that treatment with deutetrabenazine was associated with long term improvement of symptoms of tardive dyskinesia (TD). Symptom improvement with deutetrabenazine was sustained throughout the 3 years of the study and the treatment was well tolerated.


New Study Shows High Doses of Amphetamine Increase Risk for Developing Psychosis. A new study of adult emergency department admissions at Mass General Brigham, led by McLean Hospital researchers, found that individuals taking high doses of amphetamine—like Adderall—have a 5-fold increased risk for developing psychosis or mania. The highest risk was seen in patients taking 30 mg or more of dextroamphetamine, which corresponds to approximately 40 mg of Adderall. With prescribing rates for stimulants to treat attention-deficit/hyperactivity disorder (ADHD) at an all-time high, it is an important issue to note.


ARPA-H Announces First Psychologist Program Manager. Bradley E. Karlin, Ph.D., MBA joined the Advanced Research Projects Agency in Health (ARPA-H) in August and will serve as the Strategic Executive Leader in Behavioral Health Care Transformation and Innovation. Karlin will develop an ARPA-H Program to champion a core idea to improve mental health that will award projects to new multidisciplinary teams and conduct measurements and evaluations throughout the process to ensure that the best solutions advance. PMs serve an initial three-year-term, renewable up to six years maximum, to design, launch, and run all aspects of their programs.  


Data science leaders from several large pharmaceutical companies have come together to form the DISRUPT-DS roundtable. It is a forum for sharing experiences and networking, for shaping industry-level topics and for amplifying the role of data science across pharmaceutical R&D. Participants of the roundtable have recently published a paper, in Nature Reviews Drug Discovery, in which they discuss the current state of data science across the industry, opportunities and challenges going forward, and the role which the DISRUPT-DS roundtable intends to play.

STARR community friend and advocate Michelle Hammer, Schizophrenic.NYC, joined Gordon Lavigne, S&PAA, Vera Sansone, CPC Integrated Health, and Alexis Smith, BMS, for a Bristol Myers Squibb Launch and Learn panel session. The group discussed stigma and discrimination that people living with schizophrenia face and offered their unique perspectives on how stakeholders can contribute to making improvements. 


Taking place at the US Headquarters of BMS, the session was attended by thousands of BMS employees in person and virtually and was part of BMS’ annual Global Patient Week events.

Teva Pharmaceuticals US Medical Affairs was a proud sponsor of NAMI’s Inspiring Hope Through Research Event on September 10th in Washington, DC. Michelle Roberts, Teva's patient advocacy lead, had a wonderful time with friends and colleagues, and had the opportunity to meet with honoree Bruce Duncan Perry, MD, PhD, who for over 30 years, has helped shape children's mental health and neuroscience with his groundbreaking research. Also in attendance was NAMI’s Associate Medical Director, Christine Crawford, MD, MPH, who just launched her first book “You Are Not Alone for Parents and Caregivers”. 

On the occasion of the United Nations General Assembly, Boehringer Ingelheim is sharing the real stories of people living with schizophrenia. Throughout the series of videos, Bethany (USA), Derek (Canada), Hannah (Germany), Yuhei (Japan), and their respective families share their honest, brave, and resilient tales, exploring how they are overcoming several aspects of life with schizophrenia.  Watch the videos here: https://lnkd.in/e6PhiQtw  

AFSP-AR has launched The Armory Project in Arkansas!


Over 65% of all suicides are by firearm in the state of Arkansas. In an effort to change this statistic, AFSP-AR met with legislators and proposed The Armory Project, which enables fire ranges and gun shops within the state to serve as community armories -- locations for voluntary out-of-home firearm storage.


Learn more about The Armory Project, including how to bring it to your state HERE.

Please join Rural Minds and the National Grange for the Rural Mental Health Connections Webinar on Managing Postpartum Depression in rural America.


During this 60-minute webinar, Dr. Keisha Reneé Callins, a physician, public health professional, and obstetrician/gynecologist, will discuss how she works with mothers to manage postpartum depression. She is committed to providing women's healthcare services, especially in rural and underserved areas of Georgia. 

FAMILY Partnership Training Institute


NFSTAC launched a free, self-guided online course 'Partnering with Families in Behavioral Health: The FAMILY Approach' and will be offering the course through The FAMILY Partnership Training Institute. The Institute will offer providers, wraparound facilitators, and others in the behavioral health workforce an opportunity to deepen their understanding of skills to develop effective partnerships with families. Join us in this information session to learn more about the upcoming FAMILY Partnership Training Institute intended to deepen skills to develop and maintain person-centered, family-driven partnerships. 


For more information and to register for the information session, click here.

Everyone Leads: Leading Together for Collective Impact


It takes collaborative leadership to move change and that leadership must be rooted in inclusion, equity, trust, and accountability. Family Leaders and Family Peer Specialists can apply the skills taught in this session to expand the Family Peer workforce movement. 


Paul Schmitz is a faculty member of The Asset-Based Community Development Institute, was a social innovation advisor to the Obama White House, and has been named three separate years to The Nonprofit Times list of the 50 most influential nonprofit leaders in America. 


For more information and to register for the webinar, click here.

Neuroscience 2024 will be held Oct. 5-8 in Chicago. Each year, scientists from around the world congregate to discover new ideas, share their research, and experience the best the field has to offer. Attend so you can: present research, network with scientists, attend session and events, and browse the exhibit hall. Join the nearly half a million neuroscientists from around the world who have propelled their careers by presenting an abstract at an SfN annual meeting — the premier global neuroscience event.


The American Brain Coalition 2024 Annual Membership Meeting is being held on Monday, October 7th in conjunction with Neuroscience 2024 at Hyatt Regency McCormick Place in Chicago, Ill. 

Join your brain health colleagues representing patient advocacy, professional organizations, industry, and government agencies, in celebrating our continued collaboration. Plan to attend in conjunction with Society for Neuroscience’s Neuroscience 2024 meeting or attend virtually.

Click here for more information and to register.

SWP'24 Conference is being held at Yale University October 18-20! This hybrid event has virtual and in-person ticket options. Students With Psychosis is proud to partner with Mindmap and The Women's Mental Health Conference at Yale to make this event possible. Join us for a conference of learning, community-building, and celebrating what people living with psychosis can achieve when given the proper resources and support. Meet industry leads, renowned authors, social media influencers, mental health advocates, researchers, fellow SWP students, and their families as we hear from different viewpoints coming together to formulate new ideas for an insightful discussion. To learn more about Students With Psychosis, visit www.sws.ngo.

Save the Date: The 2024 International Mental Health Research Symposium will be held virtual and in-person Friday, October 25th, from 9am-12:30pm in New York City. Join the Brain and Behavior Research Foundation for presentations on leading research discoveries across brain and behavior disorders by the Foundation’s 2024 Outstanding Achievement Prizewinners and the Pardes Humanitarian Prizewinner. Awards include Outstanding Achievement in Schizophrenia Research, in Child & Adolescent Psychiatric Research, in Mood Disorder Research, and in Cognitive Neuroscience Research.

Click here for more information and to register.

Psych Congress is the nation's conference on practical psychopharmacology and a community of passionate mental health clinicians. The 37th annual Psych Congress will be in Boston from Oct. 29 - Nov. 2. This year, the Schizophrenia & Psychosis Action Alliance (SPAA) is partnering with Psych Congress to bring two special sessions: A Primer on Negative Symptoms and Cognitive Impairment in Schizophrenia and a session on Long-Acting Injectable Anti-psychotics. Members of the SPAA community can use code SPAA for a $50 discount on registration. Find more info here.

The National Federation of Families National Conference is Nov. 7-9 in Orlando, FL. The National Federation of Families is the nationwide advocacy organization with families as its sole focus, playing an important role in helping parents, caregivers, and families of children—of any age—whose lives are impacted by mental health and substance use challenges. For 35 years, NFF has brought together families, parents, community leaders, providers, partners, and legislators at the Annual Conference. For more information on the 2024 NFF Annual Conference, click HERE.

NAMI Texas Annual Conference is November 7-9 in El Paso. This year, the spotlight is on commemorating 40 Years of Hope and Healing and will be featuring captivating keynotes, enlightening workshops, a vibrant exhibit hall, continuing education credit, networking time, a special welcome reception and film screening, and delightful surprises, the Conference promises an enriching experience for all attendees. For more information on the 2024 NFF Annual Conference, click HERE.

NAMI-NYS 2024 Annual Education Conference will be held November 8-10 in Albany, NY. This year's theme is Reimagining Recovery - Breaking Barriers and Building Bridges. For over forty years, NAMI-NYS’s Annual Education Conference has been providing a platform for exploring advancements and addressing ongoing challenges in mental health. Teva, Neurocrine, J&J, Otsuka, AstraZeneca, and Intra-Cellular Therapies are among this year's sponsors. 


For more information on the 2024 NFF Annual Conference, click HERE.

CNS Summit will be held Nov. 10-13 in Boston. The meeting was founded in 2009 by leaders in the life sciences as a community to advance the work of life sciences companies with a focus on innovation, collaboration and technology.

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.

Cornell University’s College of Veterinary Medicine and NY FarmNet, in partnership with Rural Minds, are offering a free online course: Mental Health Awareness & Suicide in Rural America.



The course explores the unique mental health issues faced by rural communities across the country. You'll gain insights into the distinct factors that contribute to mental health disparities in these areas, equipping you with the knowledge to recognize and address these critical issues effectively.



Beyond understanding the challenges, this course will empower you with practical strategies for supporting mental health and suicide prevention efforts. You'll learn about how you can play a role — both directly and indirectly — in raising awareness and providing assistance to those in need. By the end of the course, you'll have the tools and knowledge you need to make a meaningful impact, fostering healthier and more resilient rural communities.

Call for Caregiver Stories!

November is National Family Caregiver Appreciation Month, a month-long tribute to those individuals providing care-giving support to a family member or loved one with a chronic illness or disability. 


In honor of this important celebration, we’re asking for caregivers' stories, photos and advice for the November newsletter.


Please email erica@thestarr.org for more information or with caregiver stories!

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.

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