STARR News & Updates

May 2024

May is

Mental Health Awareness Month!


May is Mental Health Awareness Month, when mental health news and promotions are at their peak... and the best time for ALL OF US to use this opportunity to promote our work and talk about how important mental health research is.


*Check the bottom of the newsletter for 7 things you can do for Mental Health Awareness Month!

Throughout the month, NAMI actively participates in this national movement, dedicated to eradicating stigma, extending support, fostering public education and advocating for policies that prioritize the well-being of individuals and families affected by mental illness.


This year, NAMI is celebrating Mental Health Awareness Month with the Take the Moment campaign. NAMI encourage everyone to join them in fostering open dialogues, cultivating empathy and understanding. They also urge you to share their resources to support individuals and families on their journey towards mental wellness.


Check out NAMI's MHAM resources HERE.

Mental Health America’s 2024 Mental Health Month campaign is focused on starting those conversations around mental health. While society is getting more comfortable discussing mental health, it can still be hard to know where to start when it comes to taking care of your own well-being.


This May, Mental Health America will help you:


> LEARN how modern life affects mental health with new resources to navigate our changing world.

> ACT by building your coping toolbox so you can manage stress, difficult emotions, and challenging situations.

> ADVOCATE to improve mental health for yourself, your friends and family, and your community.


MHA has resources including key messages, graphics, fact sheets, outreach ideas and much more. Check out MHA's Mental Health Month Toolkit here.


Lead by Example: Prioritize Your Self-Care


Practicing self-care is not only beneficial for you, it sets an important example for others. Your self-care practices demonstrate the importance of looking after one’s mental wellbeing. Prioritize your own mental health by implementing self-care routines and healthy coping mechanisms.


The National Council for Mental Wellbeing has created a calendar with daily suggestions and opportunities for practicing self-care this month. Print out the calendar and commit to doing these simple tasks each day!

News from the Certified Sites

The CenExel RCA staff enjoyed a Mental Health Day event at the Tree Tops Park in Florida! The day was a wonderful opportunity for the team to prioritize their own mental health and well-being, while fostering stronger bonds as a team. The event not only enhanced everyone's collective mental wellness but also served as a meaningful team-building experience.


CenExel participated in the 'Spring Into Health' health fair coordinated by the Florida Department of Health in Broward County. CenExel's Community Partnership Manager provided information about mental health, the benefits of mental health clinical research, and the clinical research studies currently open to the residents of the City of Lauderhill, Florida.

ERG Midwest Clinical Research Center's Robin Griffin was serving meals and visiting with clients at one of the six shelters and soup kitchens that they serve when a few of the clients started talking about their experience with the screening calls when they contacted the site. One lady qualified for the study, while one did not, which sparked a great conversation about inclusion and exclusion criteria. We talked about the clinical trial guidelines that are in place to protect the study volunteers' safety and ensure that the data is accurate.


Some of the other clients joined the conversation and we ended up having an engaging educational chat about what to expect when participating in a clinical trial. The open dialogue goes a long way in helping people know what to expect and building trust.

Neuro-Behavioral Clinical Research connected with local businesses and community members to offer support and education around mental health research. The NBR team hosted a booth at the Health & Wellness Fair in N. Canton, Ohio, an event dedicated to promoting a healthier lifestyle for all.


The NBR team offered information on the latest in neurology and behavioral health advancements, free memory screenings, access to their free mental health assessments, and answered visitors' questions.


Going out into the community is the best way to connect and build trust - great job, NBR!

North Texas Clinical Trials' (NTXCT) Tamara and Cherelle completed their QPR Suicide Prevention Training. This training, which focuses on Questioning, Persuading, and Referring, equips individuals, including lay and professional "gatekeepers," with the knowledge to identify warning signs of a suicide crisis and how to respond effectively. While the NTXCT staff already possesses a solid understanding of these signs and appropriate responses, Tamara and Cherelle found the additional training to be incredibly valuable and are planning to schedule additional training sessions for the whole NTXCT team.


Several team members from NTXCT actively participated in a panel discussion hosted by the National Alliance on Mental Illness (NAMI), focusing on 'Building More Diversity in the Mental Health Workforce.' The NTXCT leadership recognizes the importance of such engagements, as representation is pivotal in providing culturally competent services. This commitment ensures the highest standard of care for the NTXCT volunteers and delivers representative data to the stakeholders.

Sharlin Health team showed their support for the community at the National MS walk in Springfield, MO in April! Walk MS unites the MS community in the largest gathering of its kind to raise funds and make a difference for everyone living with MS.


In other news from Sharlin Health (in Ozack, MO), they organized a charity yardsale supporting the National MS society AND a series of charity game nights, supporting the Alzheimer's Association's The Longest Day fundraiser.


Great job showing up for your community, team Sharlin!

Richmond Behavioral Associates recognized Angela Vasquez as their Research Ambassador for the month of April. Angela is a 35-year-old female who has been living with Schizophrenia since 2016. She lives alone with the support of her family and church, and completed RBA's IPU study in April.


Way to support your Research Ambassadors, RBA!

Woodland Research Northwest (WRN), an ERG site, has been active in the community with our mobile health unit (MHU)! Have you seen the WRN MHU driving around Northwest Arkansas recently? WRN participated in the First Annual Hillcrest Towers Educational Fair in Fayetteville, AR in April. It was a great event to engage with residents and connect with local community resources. 

 

WRN understands the need to continue to educate the community about the benefits and importance of research. By participating in community events with their mobile unit, the WRN team is able to make a great impression on their community, promote the research site, and show they care.

May Spotlight Book

Should You Hide Your Schizophrenia?

by Michelle Hammer


The book Should You Hide Your Schizophrenia not only addresses this question, but also delves into various aspects of schizophrenia, a mental illness often shrouded in mystery to the general public. If you're interested in learning answers to some of the most commonly asked questions about schizophrenia, this book is for you.


Michelle Hammer is a Schizophrenia Advocate and spends her time passionately fighting stigma. While you are on her website buying her book, check out some of her amazing artwork, as well as her videos and podcast.

Children’s Mental Health Acceptance Week

May 5th - 11th, 2024


Each year Children’s Mental Health Acceptance Week gives us the opportunity to shine the light on children and youth – to focus on equity and inclusion for our young people who are impacted by mental health challenges.


Only through acceptance, advocacy, and action can we move toward social justice for families and impact social change – beginning with our children and youth.


This Children’s Mental Health Acceptance Week, NFF invites you to join the National Federation of Families in lighting the path to social justice for children and youth.

Note to Sites: This organization, Rural Minds, has excellent resources for hosting events around mental illness. They don't talk about research specifically, but you can add that piece when you host the educational event.


<-- This one-hour webinar will feature Todd Donovan, President of the Board of Directors, National Alliance on Mental Illness-New Hampshire, sharing his lived experience managing tardive dyskinesia in his rural community. Dr. Mark Frye, a psychiatrist with Mayo Clinic, will provide his medical expertise and perspective on screening for TD and managing the condition when living in a rural area.

 

For more information and free registration, CLICK HERE.

Prevalence of Mental Health Disorders Among Individuals Experiencing Homelessness: A Systematic Review and Meta-Analysis. In a review and meta-analysis, the prevalence of mental health disorders among people experiencing homelessness was 67% (95% CI, 55-77), and the lifetime prevalence was 77% (95% CI, 61-88). Male individuals exhibited a significantly higher lifetime prevalence of mental health disorders (86%; 95% CI, 74-92) compared to female individuals (69%; 95% CI, 48-84). The prevalence of several specific disorders were estimated, including any substance use disorder (44%), antisocial personality disorder (26%), major depression (19%), schizophrenia (7%), and bipolar disorder (8%).


Susceptibility to Treatment-Resistant Depression Within Families. Research out of Taiwan suggests that a family history of TRD might be a clinically significant risk factor for resistance to antidepressant treatment and increased suicide mortality, indicating that combining or altering therapies for depression might be considered instead of monotherapy at an earlier treatment stage.



HHS releases their 2024 National Strategy for Suicide Prevention. The Department of Health and Human Services and National Action Alliance for Suicide Prevention released a national strategy and federal plan to prevent suicide over the next 10 years. The updated strategy includes a new pillar prioritizing equity for populations disproportionately impacted by suicide. The new federal action plan includes identifying ways to address substance use and suicide risk together in the clinical setting; funding a mobile crisis locator for use by 988 crisis centers; increasing support for survivors of suicide loss and others whose lives have been impacted by suicide; and evaluating promising community-based suicide prevention strategies.


Bristol Myers Squibb (BMS) presented the interim long-term safety, tolerability, and metabolic outcomes data from its Phase 3 EMERGENT program evaluating KarXT in adults with schizophrenia. Not only did KarXT demonstrate significant improvements in symptoms of schizophrenia across all efficacy measures at 52 weeks, but it also demonstrated a favorable long-term metabolic profile where most patients experienced stability or improvements on metabolic parameters over 52 weeks of treatment. A majority of patients (65%) experienced reductions in weight over the course of the trial, with a mean weight decrease of 2.6kg observed at one year.


Boehringer, Sosei Ink Potential $732M Deal for Schizophrenia Treatment. Boehringer Ingelheim is paying $27.3 million upfront and further milestone payments of up to $732.6 million in a deal with Sosei Heptares to develop their portfolio of GPR52 agonists, potential first-in-class treatments targeting all symptoms of schizophrenia. The drug class is intended to treat the positive, negative, and cognitive symptoms of schizophrenia at the same time.


Alto Neuroscience announced positive Phase 1 results for ALTO-101, a novel PDE4 inhibitor in development for schizophrenia. ALTO-101 demonstrated a favorable pharmacokinetic and tolerability profile, while the novel transdermal formulation delivered significantly greater drug exposure and fewer adverse events typically associated with PDE4 inhibitors. This is the first-in-human achievement of target exposure with proprietary transdermal patch formulation. Alto plans a proof-of-concept study in cognitive impairment associated with schizophrenia (CIAS) in the first half of 2024.


A biomarker to predict risk of progression from mild cognitive impairment to dementia identified. A team of researchers reported on the a clinical study evaluating whether those with a history of major depression who suffer from mild cognitive impairment more likely to advance to dementia than those without a depression history. In some cases, yes, but depression history alone was not predictive, researchers found. Rather, EEG measurements of a brain function called TGC was predictive. Researchers found that a reduced TGC in the prefrontal cortex may be a useful biomarker of progressive cognitive decline.


Alto Neuroscience has initiated its phase 2 double-blind, single- and multiple-dose study to determine the potential of ALTO-203 as an antidepressant in patients with major depressive disorder (MDD) and higher levels of anhedonia. The study will also assess the safety, tolerability, and pharmacokinetics of ALTO-203—a novel small molecule histamine H3 receptor inverse agonist, which has demonstrated positive emotional and cognitive effects in healthy participants after 1 dose. Alto plans to enroll approximately 60 adult participants with MDD and evidence of anhedonia and plan to report the study’s topline data in early 2025.


Intra-Cellular Therapies announces positive P-3 topline results for lumateperone as an adjunctive therapy in patients with major depressive disorder. “The positive Phase 3 results in MDD represent a significant step towards our goal of further establishing CAPLYTA as a first-choice treatment across mood disorders,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. “We believe that these robust efficacy results coupled with its favorable safety and tolerability profile and convenient dosing make CAPLYTA a compelling option as an adjunctive treatment for MDD, if approved.


Neurocrine hit the main and key secondary goals of a mid-stage study focused on major depressive disorder. Neurocrine released topline data from the Phase II SAVITRI study showing that its investigational drug NBI-1065845, being developed in partnership with Takeda, can significantly lower depression severity in adults with major depressive disorder.


Gliosis, an immune response to brain injury, is found in brains of recovered COVID patients with lasting depression and cognitive symptoms. Researchers studying recovered COVID patients with lingering depression and cognitive symptoms (COVID-DC) found evidence of gliosis, an immune response to brain injury. Most affected were two brain regions: the ventral striatum and dorsal putamen. Higher readings in the latter area also were found to correlate with motor slowing. Tests of drugs to reduce gliosis may now follow in COVID-DC patients.


Biogen has seen “encouraging early trends” in the launch of its postpartum depression pill Zurzuvae, revealing in first quarter earnings drug sales that surpassed the estimates of Wall Street analysts. Zurzuvae, which was discovered by Biogen partner Sage Therapeutics and approved by the FDA last August, is the only pill available specifically meant to treat postpartum depression, or PPD. But its sales prospects are uncertain, as the condition often goes undiagnosed, and many who are diagnosed don’t receive treatment. 


Engrail Therapeutics has closed a $157 million funding round to support the development of its therapeutic assets for the treatment of anxiety disorders, depression, PTSD, and rare neurodegenerative diseases. Engrail's Phase-2 ENCALM trial for ENX-102 for generalized anxiety disorder (GAD) is scheduled for completion in June 2025.


Cerevel's Parkinson's disease drug improves symptom control in late-stage trial. Tavapadon extended the total time of symptom control by just over one hour and reduced the amount of "off" time that treated study participants experienced, meeting a secondary goal of the Phase 3 study. People with Parkinson’s often cycle between these “on” and “off” periods as the effects of mainstay drugs like levadopa and carbidopa wane. In Cerevel’s study, tavapadon was given as an adjunctive therapy to levadopa. Cerevel (which may be AbbVie by then) will share additional data from late-stage trials testing the once-daily treatment tavapadon as a monotherapy in the second half of 2024


Anti-stigma interventions in low-income and middle-income countries: a systematic review shows promise. Stigma exacerbates power imbalances and societal disparities, significantly impacting diverse identities and health conditions, particularly for low and middle-income countries. In this study, researchers completed a comprehensive review of the most updated evidence from 192 studies from lower and middle income countries, encompassing anti-stigma interventions across a wide spectrum and includes all stigmatised issues, identities, and conditions. While the findings highlight lack of representation in some countries and a higher focus on HIV/AIDS and mental health, they also underscore the effectiveness of existing interventions to reduce stigma.


Antipsychotic use during pregnancy and risk of specific neurodevelopmental disorders and learning difficulties in children: a multinational cohort study (good news). Among 213,302 children (median follow-up: 6.7 years), 11 626 (5.5%) were exposed to antipsychotics prenatally. Adjusted risk estimates did not suggest an increased risk of neurodevelopmental disorders: aHR of 1.06 (95% CI 0.94–1.20) for the composite outcome, or for poor academic performance: aRR of 1.04 (95% CI 0.91–1.18) in mathematics, and of 1.00 (95% CI 0.87–1.15) in language arts. Results were generally consistent across individual medications, trimesters of exposure, sibling- and sensitivity analyses.


Bristol Myers, Johnson & Johnson plot appeal after US judge dismisses IRA lawsuits. A New Jersey federal judge tossed lawsuits by BMS and J&J, which questioned the constitutionality of the U.S. government requiring drugmakers to negotiate with Medicare on the pricing of their products. The dismissal comes two months after a Delaware federal court rejected a similar lawsuit by AstraZeneca. “This is a disappointing ruling for patients and America’s leadership role in medical innovation,” a J&J spokesperson wrote in an email. “The IRA’s price control provisions will constrain development of new medicines, limit patient access and choice and negatively impact overall quality of care.” In his written opinion on Monday, Judge Zahid Quraishi rejected the claim of BMS and J&J that the new drug pricing program is an unconstitutional taking of their assets. “Selling to Medicare is a choice plaintiffs can accept or not accept,” Quraishi wrote. “[It] may be less profitable than it was before the institution of the program, but that does not make the defendants’ decision to participate any less voluntary.”


Study Suggests Treatments that Unleash Immune Cells in the Brain Could Help Combat Alzheimer’s. In Alzheimer’s disease, a buildup of sticky amyloid proteins in the brain clump together to form plaques, causing damage that gradually leads to worsening dementia symptoms. A promising way to change the course of this disease is with treatments that clear away damaging amyloid plaques or stop them from forming in the first place. Recent findings from a study in mice, supported in part by NIH and reported in Science Translational Medicine , offer another potential way to clear amyloid plaques in the brain. The key component of this strategy is using the brain’s built-in cleanup crew for amyloid plaques and other waste products: immune cells known as microglia that naturally help to limit the progression of Alzheimer’s. The findings suggest it may be possible to develop immunotherapies—treatments that use the body’s immune system to fight disease—to activate microglia in the brains of people with Alzheimer’s and clear amyloid plaques more effectively.


Essentials of Informed Consent to Psychedelic Medicine. Interest in administering psychedelic agents as mental health treatment is growing rapidly. As drugmakers invest in developing psychedelic medicines for several psychiatric indications, lawmakers are enacting legal reforms to speed access globally, and health agencies are preparing to approve these treatments. Meanwhile, US states, such as Oregon and Colorado, are making psychedelics available for supervised use outside the conventional health care system. Analysis of the challenges of designing and implementing psychedelic informed consent practices revealed 7 essential components, including the possibility of short- and long-term perceptual disturbances, potential personality changes and altered metaphysical beliefs, the limited role of reassuring physical touch, the potential for patient abuse or coercion, the role and risks of data collection, relevant practitioner disclosures, and interactive patient education and comprehension assessment. Because publicly available informed consent documents for psychedelic clinical trials often overlook or underemphasize these essential elements, sample language and procedures to fill the gap are proposed.

Take Action and Learn More

Action looks different for everyone. Mental Health Action Day encourages and empowers everyone to take action for themselves, for their loved ones, or for their community based on what works best for them. To learn more about mental health actions you can take, visit: MentalHealthIsHealth.us

The STARR Coalition will present the 2nd annual STARR STOP THE STIGMA CHAMPION award this Mental Health Action Day!


The Stop the Stigma Champion is a high school student that has demonstrated exceptional courage and leadership by openly discussing mental health issues, challenging stereotypes, and promoting a supportive and understanding environment in their community.


We are grateful to al that participated in this year's program and are happy to spotlight each of the other nominees in the coming months. Thanks also to the Award Committee: Leslie Franceschi (chair), Matthew Shapiro, NAMI-NYS, Sara Swanson, WCG, and Allie Freitas, Boehringer!

World Schizophrenia Day is observed each year on May 24 to raise awareness and reduce the stigma surrounding the illness.


Most of you reading this are familiar with schizophrenia; maybe you know someone living with the brain disorder, you're working with or have worked with people with schizophrenia, or at least have some familiarity with the symptoms.


SHARE YOUR KNOWLEDGE! Help others understand this serious mental illness.


We propose that for this year's World Schizophrenia Day, you do at least one of the following:


On Friday, May 24th, talk about World Schizophrenia Day with everyone you encounter.


You can say, "Happy World Schizophrenia Day!" to open a conversation.


You can help reduce the stigma.

Join APA May 4-8 for five days in New York City to leave you feeling inspired, energized, and better prepared. Choose from 500+ educational sessions led by psychiatry and mental health expert educators. In addition to the in-person event, the Virtual Annual Meeting will feature live-streams of 100+ select sessions, all accessible from the comfort of your home or office, or anywhere with a secure internet connection.

ACRP 2024 will be held May 3 - May 6 in Anaheim, CA. The Association of Clinical Research Professionals (ACRP) is where clinical researchers go for inspiration, education, and connection.

SAMHSA-Sponsored Webinar-Speak Up: Person-Centered Language Drives Equity for Individuals with Mental Health and Substance Use Challenges

Join us to hear panelists with lived experience discuss the importance of moving from mental health and substance use awareness to acceptance, in part through changing the language we use to talk about behavioral health challenges to be more person-centered.


Tentatively scheduled for May 9th, 1:30-3:00 p.m. ET

 Register here

This year's Sound Mind Festival for Mental Health is being held in Brooklyn, NY, on May 18th. It's free, but if you can make a donation, they would put it to good use. Sound Mind is based on the premise that collectively our voices are stronger, and that by amplifying musicians who are speaking openly about their mental health, we can elevate the conversation and build a community and culture that breaks the stigma that exists today. Find more information HERE.

American Society of Clinical Psychopharmacology (ASCP) 2024 Annual Meeting will be held May 28-31 in Miami Beach, FL. ASCP is the premier meeting in the field of psychopharmacology, bringing together over 900 academic and industry investigators, along with FDA and NIMH regulators, to discuss key aspects of neuropsychiatric drug development, including the impact of diagnostic changes and personalized interventions based on biomarkers or genetic information.

NAMICon 2024 will engage, challenge and include you in dynamic discussions and inspiring moments. It will introduce you to new ideas and tools you can take with you. It’ll connect you with people who will go from strangers to community—all in the name of mental health awareness, education and advocacy. Join us June 4–6 in Denver for an unforgettable experience.

At BIO 2024 you can access more than 100 sessions across 18 focus areas with discussions from leading biotechnology companies, investors, service providers, government officials, regulators, and patient advocates committed to ground-breaking therapies and innovation.. Join us June 3-6, 2024 in San Diego.

MHACon 2024 will be held September 19-21 in Washington D.C. and online. At this year's conference, explore ways to DISRUPT systemic barriers, REFORM harmful practices that prevent progress, and TRANSFORM the current landscape, ensuring everyone has equitable opportunity for optimal mental health and well-being.

For the last 35 years, the National Federation of Families has brought together families, parents, community leaders, providers, partners, and legislators at our Annual Conference. We work to leverage our lived experience and learned solutions for the support and advancement of families whose children – of any age – experience mental health and/or substance use challenges.

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

SAMHSA COE Words Matter Wednesdays



SAMHSA Centers of Excellence are hosting a series to explore equitable terminology that promotes social justice for populations where language has often been used to shame individuals, patronize, enforce prejudice, or limit visibility. Each session will provide updated language that helps advance equity within their population of focus.



Register here.

 

Each Wednesday in May

3-4 pm ET

There is still time to organize your team for this year's

NAMIWalks Spring United Day of Hope!


On May 18th, communities across the country come together for NAMIWalks Spring United Day of Hope. Not only does your participation help to magnify mental health awareness and raise funds for NAMI’s programs, but NAMIWalks are excellent events to come out and engage as part of your community!

 

Consider being a sponsor and setting up a table with information on your site along with information on the mental illnesses that your site specializes in. This is a great way to bring the community together, offering site resources, and building trust within the community!


Find your state's NAMIWalks event HERE and team up with the mental health advocates in your community!

The mission of the STARR Coalition is to create meaningful change by increasing COMMUNICATION, PARTNERSHIPS, and GOODWILL among stakeholders in the areas of mental health clinical research, advocacy, and treatment with emphasis on community and advocacy engagement, stigma reduction, and ensuring that research is widely recognized as a trusted care option.

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