STARR News & Updates

November is a time to embrace gratitude. We’re thankful for the crisp, cool air, the joy of having loved ones home for the holidays, and, of course, the warmth of Thanksgiving—a time to reflect on the value of family, friends, and the comforts of home.

At STARR, we’re especially grateful for YOU, our incredible community. The STARR Coalition community embodies the best of who we are: passionate about our work, committed to helping those in need, and always striving to make a difference. Thank you for being a part of this journey with us!

We wish you a wonderful season of gratitude and a very happy November!

November is National Family Caregiver Appreciation Month, dedicated to recognizing the individuals who provide vital caregiving support to family members or loved ones with chronic illness or disabilities.

In the U.S., over 53 million people serve as unpaid caregivers to family, friends, or neighbors, with nearly 27%—or one-third—caring for someone with a mental illness. The emotional and physical demands of caregiving, especially in the realm of mental health, can take a significant toll on caregivers' well-being.

Providing your patients' caregivers with resources and support can help them manage their mental health while caring for their loved ones. By offering them valuable information, we can help ensure they remain strong and able to care for their loved ones effectively.

MHA (Mental Health America) has developed several online guides for caregivers, including:

• Getting Started: A Guide for New Mental Health Caregivers
• Coping with caregiving stress
• Crisis resources and planning

The Caregiver Action Network has long supported caregivers across the healthcare spectrum. Their website offers a helpful infographic and tips that you can share with caregivers in your practice.

By directing caregivers to these resources, you can provide much-needed support to those who dedicate themselves to the care of others. 💚

Caregiver Story: I’VE BEEN WHERE YOU ARE

by JoAnn White 

As the mother of a dear sweet son named Douglas, I hope to give those reading this missive hope that you too can get on the other side of your loved one’s mental health challenge as I have.

At 17 years old, Douglas had a PET scan to try to identify the reason behind the symptoms he was experiencing. The doctor arrived with his colorful pictures of Douglas’ brain, pointing out red areas that he said were too hot, blue areas that were too cool, and a bunch of colors in between. The doctor said, “Your son will have a very difficult life ahead of him.” Despite the doctor’s edict, Douglas went on do well in his new HS, he went on to graduate College with honors in 3 years and he led a very independent life. We thought we dodged that bullet!

At twenty-one, Douglas was in graduate school majoring in Non-Profit Management, living on his own in Los Angeles, with a full-time job in accounting, and a girlfriend. My world was at peace until it shattered one evening when I received a call from his psychiatrist that he was at UCLA Medical Center in the locked behavioral health facility having become delusional.

So began my journey as my son’s Caregiver.

I have become a multitude of caregivers over these last twenty-five years. My initial plan which I executed was to bring him home and have him live with me, help him get well, protect him by running yards in front to him to avoid him having any more pain. I was going to select and manage his psychologist/psychiatrist/medication/daily life and fix this thing. How could I not get this under control? I am a smart successful businessperson, I love my son, I have the resources needed, how could I not make this right? But after multiple 5150’s, hospitalizations that each lasted far longer than I imagined they would, the pattern remained the same: Douglas would have a break, be taken to the hospital to stabilize, and get discharged to a rehabilitation center. As his caregiver, I would make friends with the staff, be the helper they wanted me to be, go to counseling meetings, and after two years of treatment, Douglas would immerge healthy and ready to start over again. 

I had renewed hope each time that this finally was the cure that I was looking for, until it happened again. The pattern repeated and repeated and repeated until I removed myself from the equation. One day it hit me: Douglas had to make it in life on his own. I am his mother, and that was the role I needed to serve. Now, my caregiving focuses on being present for Douglas when he needs me. My behavior changed overnight with the belief that he can make his own decisions about his life and his care and with that he began to thrive in ways I could never imagine. And guess what - I’ve thrived too.

I can report today that Douglas leads a life of joy. For the past year, he’s lived in a beautiful condo with his landlord who has been a friend from day one. He works as a peer counselor at the mental health facility where he once resided. Douglas was recently hired by NAMI for their virtual speaker program along with working in accounting for a theater in Oceanside. He has a huge group of friends and keeps himself remarkably busy every day. He knows that being busy and filling his days with planned and scheduled activities keeps him organized and healthy. His mental and physical health are major priorities along with his spiritual well-being.

I take my role of Douglas’ caregiver as a vocation with the understanding that the work never stops, and the journey is a lifetime commitment. 

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!

The American Foundation for Suicide Prevention (AFSP) is collecting data on research participation by people who have suicidal ideation. Outside of the protocols that exclude people with suicidal ideation, many sites do not include people that may have expressed any thoughts of suicide.

AFSP is looking to speak with sites that have enrolled people with suicidal ideation.

If you can help, please contact jharkavyfriedman@afsp.org. Thank you!

Start Planning Now for Your Holiday Giving & Outreach

A fundamental aspect of the STARR Site Certification is promoting community engagement and volunteering. The concept behind this is that as you forge relationships and cultivate a positive presence within the community, your work as a mental health researcher will become a more recognized and trusted resource within your community.

It's a win-win for your site and the community. But it goes way beyond that.

When done right, corporate volunteering programs are a powerful tool for fostering happier, healthier workplaces while being a force for good at the local level. These programs correlate with numerous positive psychological outcomes at both the individual and the organizational level. Research shows that employees’ participation in company-led volunteer programs has positive personal and professional outcomes. Employees who volunteer at work report five times higher well-being and 89% increased job satisfaction.

Team Volunteering

Many community nonprofits need support for their holiday events. Check with your local nonprofits and put together a short list of options for your staff to do some team volunteering. It could be cleaning up and decorating a community park or packing backpacks for school children; there are many team projects that you can explore to boost morale and participation among your staff.

Don't Forget to Provide Your Patients with Volunteer Opportunities!

Volunteering can be a powerful booster for emotional and mental health. When we help others, it leads to a sense of purpose and accomplishment. This, in turn, can reduce stress and boost your overall mood. Volunteering also provides opportunities for social interaction and building connections, which can combat feelings of loneliness or isolation. It's a natural mood-lifter, as it can increase feelings of happiness and satisfaction. Plus, knowing you've made a positive impact on someone's life can be a source of long-lasting joy and contentment.

Who needs this more than your patients?

Don't forget to invite your patients to participate in your site's group volunteer activity!

As we head into the holiday season, give some thought to how your site can spread some joy and make a positive impact on your community. Whether it's serving meals at local shelters, collecting and distributing gifts for underprivileged families, or assisting with holiday-themed events for children, volunteering helps those in need AND builds relationships and awareness of your research site AND brings a sense of fulfillment and warmth during the holiday season! ❤

As always, we are happy to help get your site engaged with your community, so don't hesitate to contact us for extra support!

References:

• Boštjančič Eva, Antolović Sandra, Erčulj V. (2018). Corporate Volunteering: Relationship to Job Resources and Work Engagement. Frontiers in Psychology, v9.   
• Brockner, J., Senior, D., and Welch, W. (2014). Corporate volunteerism, the experience of self-integrity, and organizational commitment: evidence from the field. Soc. Justice Res. 27, 1–23. doi: 10.1007/s11211-014-0204-8
• https://www.galaxydigital.com/blog/corporate-volunteerism

The Effects of Gratitude Last Longer Than You Think

Feeling and expressing gratitude can make you happy in the moment—just think back to the joy you felt the last time a friend helped you out or your partner cooked a gourmet dinner—and a growing mound of evidence shows that giving thanks can also have a lasting effect on your mood. One study from the University of Pennsylvania found that people who wrote and delivered a heartfelt thank-you letter actually felt happier for a full month after, and the same researchers discovered that writing down three positive events each day for a week kept happiness levels high for up to six months.

Intra-Cellular Therapies announced positive topline results in phase 3 trial evaluating CAPLYTA for the prevention of relapse in patients with schizophrenia. On the primary endpoint, time to relapse during the double-blind treatment phase was significantly longer in patients receiving lumateperone compared to those receiving placebo (p=0.0002). There were 18 relapses (16.4%) in the lumateperone group versus 44 relapses (38.6%) in the placebo group. Treatment with lumateperone was associated with a 63% reduction in risk of relapse versus placebo (hazard ratio [95% CI] = 0.37, [0.22, 0.65]).

Seaport Therapeutics, kick started by the former leaders of Karuna Therapeutics, has raised $225 million in an oversubscribed Series B to fund a pipeline of neuropsychiatric medicines. The programs in Seaport’s pipeline use the Glyph platform, which is designed to enable and enhance oral bioavailability, avoid first-pass metabolism and reduce liver enzyme elevations or hepatotoxicity and other side effects to advance clinically active drugs that were previously hindered by those limitations. The most advanced therapeutic candidate in the pipeline is SPT-300, an oral prodrug of allopregnanolone that is being advanced into a Phase 2b study for major depressive disorder with or without anxious distress that has the potential to be registration-enabling. SPT-320, a novel prodrug of agomelatine being advanced into Phase 1 studies for the treatment of generalized anxiety disorder (GAD), has the potential to be the first new mechanism for GAD in decades. 

First Episode Schizophrenia: Intervening Early and Well. The first episode of schizophrenia is typically preceded by a clinical high-risk period occurring several months to years before the onset of frank psychosis. This period often includes nonspecific symptoms such as depression, anxiety, and social and cognitive deficits, all of which contribute to gradual functional impairment. Given the significant long-term impact of schizophrenia, there has been a focus on early intervention with comprehensive treatment for the first episode, as early treatment is generally associated with better outcomes throughout medicine. In psychosis, there is a prognostic benefit from keeping the duration of untreated psychosis short once the psychotic threshold has been crossed.

First synaptic regenerative therapy for schizophrenia under investigation. Spinogenix recently announced that multiple sites are now 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.1 SPG302 focuses on addressing a key feature of schizophrenia that may contribute to all symptom domains: a loss of glutamatergic synapses. 

TEV-'749, a long-acting injectable, showed positive phase 3 trial results for schizophrenia, presented at the ECNP Congress. Christoph U. Correll, MD, shares new data on Teva Pharmaceuticals' TEV-'749 for adult patients with schizophrenia. The investigational drug uses SteadyTeq technology to release olanzapine without causing postinjection delirium/sedation syndrome (PDSS). 

Antipsychotic Drugs and Cognitive Function: A Systematic Review and Pairwise Network Meta-Analysis. The analysis looked at which antipsychotics are associated with the most beneficial outcomes regarding cognitive function and, secondarily, quality of life and social functioning. The systematic review and pairwise network meta-analysis including 68 studies involving 9525 participants found no clear differences in outcomes between antipsychotics; however, first-generation dopamine antagonists, such as haloperidol and fluphenazine, and clozapine with its anticholinergic properties, ranked low. Moreover, no specific antipsychotic could be connected with a clearly more favorable outcome than placebo, and the measurement of cognitive performance was highly heterogeneous and often not comprehensive.

What is the relationship between cognitive impairment in psychotic disorders and exposure to a variety of risk factors? A cross-sectional study found that a significant proportion of the cognitive impairment observed in psychotic disorders may reflect greater exposure to cognitively deleterious risk factors in this group. Cognitive impairments in psychotic disorders do not only reflect disease-specific effects.

FDA grants Fast Track designation for Denovo's biomarker-guided DB104 (liafensine) in patients with Treatment-Resistant Depression (TRD). This presents a new era for the first-in-class triple reuptake inhibitor, liafensine, which targets targeting transporters for serotonin, norepinephrine, and dopamine. This is the first time a genetic biomarker has been used to help those in this patient population. 

Supernus Pharmaceuticals reported that its experimental drug SPN-820 showed "clinically meaningful improvement" within two hours of administration in a Phase IIa open-label study. Supernus expects topline results from its ongoing 227-patient placebo-controlled Phase IIb study of SPN-820 in treatment-resistant depression (TRD) in the first half of 2025. CEO Jack Khattar says that study will provide a clearer picture of the development path forward for SPN-820. "We really need to see the Phase IIb data clearly to make a final assessment as to which way we're going to go with this drug, MDD or TRD, or which one at first, or maybe together in parallel," he said.

Lykos' path forward for PTSD psychedelic will feature another trial after all. With a new interim CEO and chief medical officer at the helm, Lykos has come around to the US regulator's way of thinking, acknowledging in a statement on Friday (10/18/24) that the drug's path forward will include an additional Phase III trial. 

Low-Dose Lithium shows promise in preventing dementia and reducing suicide risk, with evidence supporting its neuroprotective effects. Microdoses of lithium may address a potential deficiency, improving mood, irritability, and cognitive function. For decades, data have slowly been building that lithium has a much wider dose-response curve with potential utility at lower doses.

Mental Health in the Sun: The Role of Vitamin D Deficiency in Mental Illness. Recent research has highlighted important functional aspects of vitamin D. Vitamin D plays a neuroprotective role, influencing serotonin synthesis and brain plasticity, relevant for mental health conditions like depression and anxiety. Deficiency in vitamin D is linked to increased risk of depression, ADHD, anxiety, and suicide, with supplementation showing potential benefits. 

Building the American Brain Economy. Transitioning from a nation struggling to address brain health deficits to one that proactively advances brain health, performance, and skills—a brain-positive economic transformation—will require a systems approach. There is no silver bullet for solving our brain challenges; we need a systemic set of policies to stop and reverse the loss of American brain capital, encompassing social, emotional and cognitive brain resources, and to chart a course to a more productive, creative, and flourishing nation. [Patriotism aside, this commentary article offers some interesting observations for building a 'brain economy'.]

Revolutionizing Pharma: The Power of AI and Chatbots in Clinical Trials and Beyond. Large language models (LLMs), generative artificial intelligence (AI), and chatbots offer unprecedented opportunities to enhance clinical trials, streamline the dissemination of pharmaceutical information, and accelerate drug discovery. In this manuscript, we explore how AI is being utilized to improve efficiency, ensure better patient outcomes, and revolutionize communication strategies in the pharmaceutical landscape.

Jelena Kunovac, MD, MS, discusses last week's approval of Cobenfy, an agent with a novel mechanism of action that could revolutionize schizophrenia treatment. A short video, well worth the watch.

One clinical psychiatrist's experience administering ketamine in a small group (two patients) setting. A short read for those interested in working with psychedelics.

Bristol Myers Squibb's Cobenfy recognized as one of TIME Magazine's Best Inventions of 2024! Time Magazine's best inventions for 2024 are “changing how we live, work, play, and think about what’s possible.”

Every year, Time editors and correspondents around the world gather nominations for the magazine’s Best Invention issue. Each contender is evaluated on a number of key factors, including originality, efficacy, ambition, and impact. Not that we needed further confirmation of the impact that this new mechanism will have on those living with schizophrenia...  ❤

Boehringer Ingelheim is partnering with the WHO Foundation to address equitable access to healthcare and suicide prevention in the Americas. This 3-year collaboration will focus on reducing suicide rates in the Americas and improving access to quality mental health care for vulnerable populations, including those affected by serious mental illness.

Boehringer Ingelheim pledged USD 5 million to advance access to quality healthcare services for all, with a special focus on vulnerable populations in the Americas who are at greater risk of suicide.

National Shattering Silence Coalition member, peer, and author Darrell Herrmann wrote a guide to help those who have a psychotic illness, and those who care for those who have a psychotic illness.

Inside this six-page handguide, Mr. Herrmann explains psychosis, anosognosia, and psychotic illnesses' symptoms in layman's terms. Anti-psychiatry, recovery, and successful treatment methods are also discussed. You can download this peer-written PDF guide on the NSSC website (here). No sign-up is required.

BD² and DBSA Partner to Improve the Lives of People Living with Bipolar Disorder. BD²: Breakthrough Discoveries for Thriving with Bipolar Disorder and Depression and Bipolar Support Alliance (DBSA) are pleased to announce a partnership that will provide peer support, community-building opportunities, and wellness tools to participants in the BD2 Integrated Network study, an initiative which seeks to gain new insights into bipolar disorder and accelerate improvements to bipolar care. The partnership with DBSA will include peer support and wellness resources for Integrated Network participants. These tools are designed to foster community, improve health outcomes, and provide valuable data-driven insight into best practices for supporting holistic wellness so that people living with bipolar disorder are empowered to thrive.

International Bipolar Foundation (formerly known as California Bipolar Foundation) announced the launch of their new page, "I Am a Teen with Bipolar Disorder", a resource for teens, showing them that they’re not alone, that many others have been through this journey, and that living a healthy, fulfilling life is absolutely possible.

Even a Single Act of Kindness Can Go a Long Way...

Scientists studying positive psychology found that a one-time act of thoughtful gratitude produced an immediate 10% increase in happiness and 35% reduction in depressive symptoms. The happy effects disappeared within three to six months which shows that gratitude is an act to be repeated again and again.

Start Today: Every act of gratitude counts, and it can be as small as saying thank you or telling someone important how much they mean to you.

The Schizophrenia & Psychosis Action Alliance (S&PAA) created the

“I’m Diagnosed. Now What?” toolkit, designed to help navigate the early stages of one's schizophrenia diagnosis with practical advice, resources and encouragement.

Part 1 of the toolkit explores ways to understand the condition, manage the symptoms, and take important steps toward recovery.

Part 2 delivers practical guidance, tips, and tools aimed at achieving stability and setting a foundation for long-term success.

We highly recommend that all sites —whether or not you directly serve individuals with schizophrenia — consider printing and sharing these exceptional resources in your waiting areas or distributing them directly to patients.

Download the “I’m Diagnosed. Now What?” toolkits 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.

S&PAA is hosting the Innovations in Treatment Webinar Series, starting with 'Understanding Positive Symptoms in Schizophrenia' on Dec. 12th 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.

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.

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.