The STARR News: February 2023
Congratulations to the 2022 Sponsor of the Year Award:

Otsuka was honored for their work supporting mental health research and advocacy, and particularly for their phenomenal support of the STARR's Project RockSTARR program.

Since 2020, Otsuka has been running RockSTARR programs as part of their MDD and PTSD trials. They have budgeted more that $200,000 for local NAMI, MHA, and DBSA advocacy chapters, on behalf of the volunteers in their studies. The checks are sent to the research site to be delivered to the advocacy offices, creating thriving relationships between the sites and their local community mental health advocates!

Otsuka has a long history supporting individuals living with mental illnesses and patient advocacy organizations. Otsuka employees are passionate about making an impact by taking part in initiatives that help build communities and support charitable organizations. Among the many organizations Otsuka supports are NAMI, AFSP, MHA, the National Council for Behavioral Health, Families for Depression Awareness, and Caring Kind.

Otsuka established the Sozosei Foundation in late 2019 as a philanthropic arm of Otsuka. The Foundation’s primary focus is to eliminate the use of jail and prisons for the diagnosis and treatment of mental illness. In addition to the primary focus on the decriminalization of mental illness, the Sozosei Foundation also supports efforts to build resilient, healthy, and vibrant communities in Stockton, California; City of Baltimore, Maryland; and Camden, Newark, Patterson, and Trenton, New Jersey, and engages in disaster relief and recovery in places where Otsuka has a presence globally.

Accepting the award on behalf of Otsuka was Dr. Shelley Weaver, the Associate Director of Clinical Management for Otsuka. Shelley and the Otsuka team have been involved with the STARR Community, especially with respect to Project RockSTARR. We look forward to working with Shelley and the Otsuka team on RockSTARR programs well into the future!

Congratulations to Otsuka!
Project RockSTARR is a donation program that puts sponsors' advocacy support to work building relationships between advocacy and research at the local level, and supporting community efforts to help those living with mental illnesses.

February is
Black History Month

Every February, the U.S. honors 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.

This year's theme is Black Resistance. By resisting, Black people have achieved triumphs, successes, and progress including ending slavery, dismantling of Jim and Jane Crow segregation in the South, increased political representation at all levels of government, desegregation of educational institutions, the passage of Civil Rights Act of 1964, the opening of the Smithsonian National Museum of African American History in DC and increased and diverse representation of Black experiences in media. Black resistance strategies have served as a model for every other social movement in the country, thus, the legacy and importance of these actions cannot be understated.

Historically and today in the 21st century, Black people have worked the political angle to seek their place in the country. Where race is concerned, legislative or judicial action to deal with controversial issues has often come late. The historic Executive Orders 8802 and 9346 were responses to A. Phillip Randolph and the all-Black March on Washington Movement’s threat to lead a 50,000-strong Black worker’s march into Washington, D.C. And all three of the Civil Rights Act, the Voting Rights Act and the Fair Housing Act were concessions to the Civil Rights and Black Power movements. Every advance, improvement in African Americans quality of life, and access to the levers of power to determine their own destiny has been achieved through struggle.

This month, take some time to learn about and share Black history and support Black-owned businesses and charities.
STARR Diversity Workgroup Update

The STARR Diversity Workgroup has been busy, setting new goals for this year and bringing in new members, including new co-chair, Letitia Griffin (see her spotlight below). The focus of the workgroup is to ensure progress in research and the mental health workplace by collaborating with other professions to instill diversity, equity, and inclusion practices. The workgroup meets bi-monthly to build DEI resources, best practices guidelines, and tools for the STARR community. Objectives include educating diverse communities on clinical research and building trust within communities on the safety and efficacy around clinical research.

Deliverables created by the workgroup include:
  1. Diversity Resources area on website
  2. Diversity Pledge
  3. Site DEI Survey (only open to Certified Sites)

For Black History Month, the Diversity Workgroup has created a series of graphics to spotlight some of the medical achievements made by African Americans. You can find these resources on the STARR website HERE or watch for them all month long on our social media outlets!

The diversity resources are another great reason to be STARR Certified!
Join the STARR Diversity Workgroup
and help drive the 2023 DEI initiatives!
Contact for more information!
Breaking Barriers: 
Letitia Griffin, APRN

The STARR Coalition is incredibly fortunate to welcome Letitia Griffin, APRN, as the new Co-Chair for the STARR Diversity Workgroup
Letitia says that she has always been interested in the various ways that pharmaceuticals can impact people based on their genetic makeup, specifically people of color. For this reason, she felt that clinical research was the perfect fit for her and has been a force in the industry for many years. 
Letitia serves as the Director of Diversity, Equity and Inclusion at CNS Healthcare where she is cultivating partnerships within the Florida community through a mobile outreach van to provide care for underserved communities. Through mobile outreach, Letitia and her team are able to provide basic checkups, screenings, and educational materials to the community. The work that Letitia does not only provides care to those in need, but it spreads the message that research is a trusted care option, particularly mental health clinical research. 
Not only does the outreach van provide care, it also is a way to inform the community about mental health clinical research as a career option. Letitia visits universities and job fairs as a way to highlight the importance of providing patient-centered care to the community regardless of their circumstance and to advocate for careers in clinical research. Letitia and her team continue to overcome barriers that prevent treatment such as access to services, educational materials, and utilizing language that is inclusive and clear. 

We look forward to gaining new insight on creating meaningful change in our communities from Letitia and her team.

Don't miss this month's Spotlight Podcast with Letitia!
The STARR's Director of Advocacy Engagement, Mallory Mercer, sat down with Letitia Griffin for this month's spotlight podcast. Check out Letitia's experience with outreach on behalf of CNS Healthcare and how she is building trust within the community. Listen to the podcast HERE.
We are delighted to welcome
North Texas Clinical Trials
as the newest STARR Certified site!
North Texas Clinical Trials is an independent clinical trials site, located in Fort Worth, Texas, with a mission to provide quality data through trusted care. Comprised of experienced and dedicated staff, collectively having decades of experience in medical device and pharmaceutical drug trials ranging from phase I-IV across a wide range of therapeutic areas. NTXCT continues to effectively combine strategic volunteer recruitment and retention with exceptional, high-quality clinical trial conduct.

The STARR Certified sites have have received an email from us regarding Teva’s new study to assess the impact of tardive dyskinesia (TD) and real-world treatment patterns and outcomes. The Phase 4, multicenter, prospective, observational two-part study is the largest-ever study of its kind for TD and will collect information from both patients and physicians on TD. The study will evaluate how the condition progresses over time and impacts a person’s quality of life, as well as outcomes related to treatment with AUSTEDO (deutetrabenazine) tablets.

Read the press release HERE for a quick overview or visit the TD Impact Registry HERE.
Brandy Isaacks Joined CenExel as Vice President of Project Management & Scientific Affairs. In case you were wondering where Brandy was, she left Syneos to join the team at CenExel. Brandy’s responsibilities will include providing project management coordination and support across CenExel Centers of Excellence. She will also manage CenExel’s Scientific Affairs division which encompasses early phase and translational medicine scientists, plus the broader network of CenExel therapeutic experts, supporting and consulting on the design and execution of clinical trials. Congratulations, Brandy!
CNS Healthcare is pleased to announce the 2022 Employee of The Year, Vladimir Predestin! Vlad is part of the CNS Healthcare Site Support Center team and provides IT services to the Orlando, Jacksonville, and Memphis research sites.

Congratulations, for your great work supporting the CNS Healthcare team, Vlad!
Midwest Clinical Research Center (MCRC) has partnered with the House of Bread local soup kitchen, helping out and providing coats, gloves, hats, thermal underwear, blankets, food, and other supplies. The WCRC staff works with the regular volunteers and guests, which has given MCRC staff the chance to talk with House of Bread clients about research opportunities.
Dr. Scott Fisher, Lead Psychedelic Facilitator for Segal Trials, moderated the The Art of Healing panel with @mayahippy_lcsw @elischeier_ @juliagracelove and Michael Lande at @artwithmelife and is scheduling upcoming panels. We're looking forward to the videos!
Organization Spotlight:
Black Women in Clinical Research

When Danielle Mitchell founded Black Women In Clinical Research, she did so with the intention of creating a space where black women could come together, support one another, and create dialogue on the research industry that has historically missed the mark on Diversity, Equity and Inclusion. The result will change the way the pharmaceutical research industry views inclusionary practices, both within the workforce and for research volunteers.

BWICR continues to grow exponentially, promoting careers in clinical research within African American communities. One way members connect is through their app, which gives members the opportunity to meet other women of color in the industry, find educational materials on work/life balance, access resources for stress management specifically created with people of color in mind. The BWICR app also provides women of color interview tips, speaking opportunities, and a job board.
Organizations nationwide that are looking to hire driven, competent employees can access the BWICR network through the Mighty Networks App by contacting Danielle. This community has become so much more than Danielle ever imagined, creating a safe space for black individuals in clinical research to find crucial support and encouragement in an industry that still has much work to do. We are proud to help elevate BWICR and encourage our Coalition members to utilize the resources that are literally in the palm of your hand.
ASENT Annual Meeting 2023, being held March 13-15, 2023, will be virtual and free to attend. Learn about the latest in neurotherapeutics including innovations across disease states, novel delivery systems, gene therapy and biomarkers, and drug therapies and devices. Learn more here.

The ADAA 2023 Conference will be held on April 13-16, 2023, in Washington, DC at the Renaissance Washington, Downtown DC. The theme for the conference is From Science and Technology to Evidence-Based Practice: Enhancing Access Through Integration. For more information, click here.

ACRP 2023 is being held April 28-May 1 in Dallas. The Association of Clinical Research Professionals (ACRP) invites clinical research professionals to join them to learn strategies, best practices, and creative solutions for improving clinical trial quality and advancing your career. Learn more here.

American Psychological Association (APA) 2023 Annual Meeting is being held May 20-24, 2023 in San Francisco, CA. This year's theme is 'Innovate, Collaborate, Motivate: Charting the future of mental health'. For details and to register, click here.
Join the NAMI community for NAMICon 2023! Whether you connect in-person, May 24-27 at the Minneapolis Convention Center, or online, June 6-8, there is so much to learn and experience at NAMICon 2023. Build connections, be inspired, reenergize and reaffirm your commitment to building better lives for those affected by mental illness. For details, visit NAMICon.

NAMI is now accepting proposals for NAMICon 2023 - get the details here.
The Annual Meeting of the American Society of Clinical Psychopharmacology (ASCP) to be held at the Loews Miami Beach Hotel on May 30 – June 02, 2023. Submissions are open for presentations and posters. Details can be found here.

The 148th Annual Meeting of the American Neurological Association (ANA2023) will be held in Philadelphia, September 9-12, 2023. Learn more here.

The Site Solutions Summit is being held October 6-8, 2023 in Hollywood, Florida. Organized by the Society for Clinical Research Site (SCRS), the Site Solutions Summit provides a unique hub where sites, sponsors, CRO executives, and regulators come together to discuss best practices and ideas while developing strategic partnerships through ideation sessions, workshops, and focus groups. Learn more here.
The 2023 Mental Health Services Conference, October 12-14, in Washington, D.C., brings together everyone caring for those with mental illness, including psychiatrists, nurse practitioners, primary care physicians, social workers, and more, to collaborate on practical advice to influence systems-level change for their patients. Learn more here.

6th Edition of International Conference on Neurology and Brain Disorders Conference (INBC2023) will be held in Boston, October 19-21, 2023. More information here.
Research out of the University of California Davis looked at population-based screening for first-episode psychosis (FEP) in community mental health settings substantially increases identification of individuals with psychosis spectrum disorders but does not reduce the overall duration of untreated psychosis, so reduction efforts must also specifically target delays between symptom onset and first contact with mental health services. Reducing the duration of untreated psychosis (DUP) is essential to improving outcomes for people with first-episode psychosis (FEP). Based on the review, current US approaches are insufficient to reduce DUP to international standards of less than 90 days.

An Emory University study published in Molecular Psychiatry shows levodopa, a drug that increases dopamine in the brain, has potential to reverse the effects of inflammation on brain reward circuitry, ultimately improving symptoms of depression. Levodopa, a drug commonly prescribed for the treatment of Parkinson’s disease, was found to reverse the effects of neuroinflammation on the reward system and improve symptoms associated with depression.

Tufts University Study reveals heightened activity in the amygdala in response to seeing surprised or neutral facial expressions could be a biomarker for the risk of developing PTSD following trauma. The team studied male identical twin pairs using fMRI studies of brain activation. By studying identical twins, who share the same genes, the researchers could show which traits are familial and which are not. In a set of 12 identical twin pairs one twin had experienced trauma and developed PTSD, while the other was not trauma-exposed. A set of 15 identical twin pairs were used as a control group. One member of that twin set had experienced trauma but not developed PTSD, and the other was not exposed to trauma.

Massive health-record review links viral illnesses to brain disease -- An analysis of about 450,000 electronic health records has found a link between infections from influenza and other common viruses and an elevated risk of having a neurodegenerative condition such as Alzheimer’s or Parkinson’s disease later in life. But researchers caution that the data show only a possible connection, and that it’s still unclear how or whether the infections trigger disease onset. The analysis, published in Neuron, found at least 22 links between viral infections and neurodegenerative diseases.

The good/bad memory peptide: Neurotensin orchestrates valence assignment in the amygdala -- Researchers at the Salk Institute in La Jolla, California, used CRISPR to knock out certain genes in mice, and in so doing, demonstrated that a small neuropeptide in the brain’s basolateral complex of the amygdala, called neurotensin, is responsible for the brain’s decision to color a memory as either good or bad. It’s very likely the same mechanism in humans. (Thanks to Neo-Life for this one!)

Accelerating Medicines Partnership® Schizophrenia (AMP®SCZ) is developing tools to enable early intervention in the psychosis high risk state. STARR founding member Carlos A. Larrauri co-chairs the AMP SCZ Steering Committee and helps lead the international collaboration, which was formed to develop algorithms using a set of clinical and cognitive assessments, multi-modal biomarkers, and clinical endpoints that can be used to predict the trajectories and outcomes of clinically high risk (CHR) individuals and advance the testing of pharmacological interventions for CHR individuals in need. For more information on AMP SCZ and to get involved, visit the website here.

ADAA is delighted to announce the launch of a new free Major Depressive Disorder (MDD) peer to peer online support community. The new community offers a safe place for subscribers to learn and share experiences with others. 
Are you STARR Certified?
The STARR Site Certification was created to help advance mental health clinical research by promoting community engagement, empathy, and communication between research sites, staff, patients, and advocacy groups, as well as providing support for best practices around working with advocacy, suicide prevention, and other areas that enhance clinical research.
Everything The STARR Coalition does comes from our stakeholders looking to make positive change. 

The STARR Coalition is a 501(c)(3) nonprofit organization, our Tax ID # is 47-4634007.
Sites -- please share your feedback!

In general, how much effort does your site put into the recruitment of culturally diverse populations?
Please select one response:
A LOT - we have a recruitment person whose ONLY focus is diversity.
A significant effort - we have diversity recruitment tactics that we employ.
Some - we follow sponsor guidelines and do our best.
Minimal - we have minimal access to diverse populations.
None - it's not really applicable to our studies.
Results from last month's survey to sites:
Request for Survey Response:
The National Federation of Families (NFF) provides free resources, training, and technical assistance to families, caregivers, and those who support families accessing mental health and substance use services and to clinicians interested in increasing their knowledge of best practices to engage with Family Peer Specialists and family members.

NFF is conducting a brief 9 question survey that will help guide NFF efforts in creating resources that meet the needs of clinicians to engage with families in behavioral health settings. Please complete this survey by March 1, 2023 to share your experience around receiving instruction in family engagement during your formal education and training. Take the survey HERE.
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The STARR Coalition is a 501(c)(3) nonprofit organization, our Tax ID # is 47-4634007.
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