STARR News & Updates

June 2024

There are currently about 12 million people in the United States with PTSD.


Even though PTSD treatments work, most people who have PTSD don't get the help they need.


June is PTSD Awareness Month and there is something that you can do to help raise awareness of the symptoms and treatment options.


We've got a longer article below with info on the prevalence and symptoms -- please take a moment to read it if for no other reason than it's PTSD Awareness Month.


Everyone with PTSD - whether they are Veterans or civilian survivors of a traumatic event - needs to know that treatments really do work and can lead to a better quality of life.


June 27th is PTSD Screening Day -- answer the 5 questions to see if you may have PTSD. And share the link on your social media and via text to your contacts so they can take the self-test. Or, you don't have to wait until June 27th.

News from the Certified Sites

Sharlin Health Neuroscience Research Center, in Ozark, MO, became a STARR Certified Site earlier this year and we've been waiting for the team picture with their Certification plaque, but we never expected it to be this good!


Led by Ken Sharlin, M.D., M.P.H., IFMCP, a board-certified neurologist, the team at Sharlin Health is passionate about creating a positive, lasting impact on their patients. Although their focus has been primarily neurological disorders, they are expanding into psych studies, and have brought in staff with SMI expertise.


Pictured above are (bench row left to right) Jessie, Shawna, Mikhayla, and Teddy the dog. The back row left to right is Katelynn, Tina, Hannah, Jackie, and Jami.


Please join us in welcoming Sharlin Health into the STARR Community!

The CenExel RCA staff celebrated Clinical Trials Day with some time out for the staff to get together, play some games, and have some fun! A special shoutout to the amazing team at CenExel RCA! Your dedication, and passion for clinical research are truly inspiring.

Thank you for everything you do!

The Pillar Clinical Research Richardson team supported the North Texas NAMI Walk last month! Pillar Clinical Research was a gold sponsor, and our team included Team Captain and Recruitment Manager, Chase Pearson,  Site Director, Jordan CruzVice President of Regulatory Affairs, Claudia Powell, Clinical Research Coordinator, John Vu, CMO, Chief Experience Officer, Bruce Trimble, and Principal Investigator, Dr. Scott Bartley and Annie, Dr. Bartley's pig.

North Texas Clinical Trials' (NTXCT) team had an amazing time supporting NAMI North Texas at the NAMI Walk at Rough Rider field in Frisco. They brought friends and family out to raise awareness for mental health, break the stigma of mental illness, and to celebrate Mental Health Awareness Month.


The NAMIWalks North Texas 2024 pet and family friendly event includes resource tables, a kid zone, free Kona Ice for kids, "Why I Walk" story station, HoneyLu's coffee, fun for all ages, and more!

Evolution Research Group (ERG) has developed “MyTrialApp”, a mobile app created for current and potential future participants of ERG clinical studies to improve patient engagement and retention.


Key features of the app include:

  • Patient Recruitment and Enrollment: Patients can easily find relevant clinical trials based on their medical conditions, location, and preferences.
  • Improved Communication: Volunteers can stay connected and informed about their current ERG study, including managing appointments and viewing account balance and payments.
  • Engagement and Retention: Increase interactions between study participants and ERG via mobile channels.
  • Study Exposure: Enable users to learn about and apply for upcoming study trials across all ERG sites.
  • Education: Materials are viewable on the application to inform patients about clinical trials, medical research, and various healthcare topics
  • Privacy and Consent Management: The app ensures patient privacy and compliance with data protection regulations. Participants can provide informed consent electronically.

Celebrating an Exceptional Member Achievement: Carlos Larrauri

Carlos Larrauri, a cherished friend of the STARR Coalition and dedicated advocate for individuals living with schizophrenia, has successfully earned his Law Degree from the University of Michigan Law School AND his Masters in Public Administration from the Harvard Kennedy School!


"Four years, three cities, two degrees, and one loving and supportive community of family, friends, and colleagues who helped make it all possible. Thank you for believing in me and helping me achieve my dreams."


Join us in celebrating Carlos' outstanding accomplishment! Now it’s time to hit the books for the bar exam!

Around the world, June is recognized as LGBTQ+ Pride Month to commemorate a tipping point in history — the Stonewall Uprising, which lasted 6 days in Manhattan in June 1969 as police clashed with LGBTQ protesters.


But you don’t have to be LGBTQ to celebrate Pride - Pride can, and should, be celebrated by all, even if you identify as straight!


What could be a better time than Pride Month to run a company-wide DEI and Culture survey to measure the degree to which your company culture creates a diverse, equitable, and inclusive environment where people of all backgrounds can thrive.


Just having a DEI-specific survey sends a powerful message to your workforce. In fact, Culture Amp's 2022 Workplace DEI Report found that employees who have taken a DEI-specific survey feel more positively about decision quality, growth opportunities, and their relationships with their manager and others in the organization.


One important layer of any DEI survey is collecting and reporting on employee demographics. Depending on how you want to measure the makeup of your workforce, the employee demographics could include age, gender, sexual orientation, parental status, race or ethnicity, neuro-diversity, or other characteristics. Obviously, it will have to be anonymous and optional,and presented in a way that focuses on how the information would be used to help pinpoint areas for improvement and drive meaningful action.


Give it some thought. It could be a valuable tool in your overall DEI strategy!

Live Your PosSCZible is a national initiative bringing to light what people with schizophrenia can achieve, supporting them as they plan for the future and providing them with resources to take action.


Bristol Myers Squibb, Taye Diggs, and the Schizophrenia Community have partnered to empower people with schizophrenia through the Live Your PosSCZible campaign. The initiative is focused on elevating the voices of those with schizophrenia and their care partners to drive impactful conversations about the aspirations of the community. Actor and author Taye Diggs and his sister, Christian, who was diagnosed with schizophrenia as a young adult, share their experiences alongside members of the schizophrenia community, including several STARR community members, who live with the disorder.


Live Your PosSCZible also provides resources to increase the understanding of schizophrenia, reduce stigma, and promote empathy.

June marks PTSD Awareness Month, dedicated to raising awareness about Post-Traumatic Stress Disorder (PTSD), a condition that affects millions worldwide. To this end, we bring you a deep dive into PTSD.


We know that those of you reading this are very familiar with PTSD, but in honor of PTSD Awareness Month, please take 3 minutes to read this article.

 

PTSD is more common than many realize: according to a PubMed article published in December 2021, the prevalence of PTSD among civilians ranges from 8.0% to 56.7%, 1-year prevalence from 2.3% to 9.1%, and lifetime prevalence from 3.4% to 26.9%. In military populations, point prevalence ranged from 1.2% to 87.5%, 1-year prevalence from 6.7% to 50.2%, and lifetime prevalence from 7.7% to 17.0%.

 

Prevalence is elevated in subpopulations including emergency responders, refugees, American Indian/Alaska Natives, individuals with heavy substance use, individuals with a past suicide attempt, trans-masculine individuals, and women with prior military sexual trauma. Female sex, lower income, younger age, and behavioral health conditions were identified as risk factors for PTSD.*

 

About one third of children who experience a traumatic event will develop PTSD.

Symptoms of PTSD can be diverse and often overwhelming and other problems can develop alongside PTSD including anxiety or depression, defiant behavior, ADHD, and in teenagers and young adults, suicidal thoughts and alcohol or drug use. Up to 80 per cent of people who have long-standing PTSD develop additional problems - most commonly depression, anxiety, and alcohol or other substance misuse. These may have developed directly in response to the traumatic event or as a result of the effects of having PTSD.

 

To complicate the problem, many don’t recognize their symptoms, and those that do, may not know that PTSD is treatable.

 

During PTSD Awareness Month, it is essential to spread the word about the prevalence, symptoms, and the availability of treatments for PTSD. If someone near you (beyond your study patients) may have PTSD or a PTSD-related illness, take this opportunity to encourage them to seek help.

 

Understanding that PTSD is a common and treatable condition can make a significant difference in reducing stigma and supporting those who are struggling.

 

Let’s take this opportunity to educate ourselves and others, fostering a supportive environment where individuals with PTSD feel understood and empowered to seek the help they need. By spreading awareness and promoting effective treatments, we can make a meaningful impact in the lives of those affected by PTSD.

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*PTSD prevalence estimates varied widely, partly due to different study designs, populations, and methodologies, and recent nationally representative estimates were lacking.

 

Sources:

Announcing the 2024

Stop the Stigma

Champion:

Max Delgado


The winner of the 2nd Annual STARR Stop the Stigma Champion Award is Maximiliano Delgado of Rogers High School in Rogers,AR!


Nominated by the Arkansas Chapter of the American Foundation for Suicide Prevention (AFSP), Maximiliano (Max) Delgado is currently a senior at Rogers High School in Rogers, Arkansas, where he has been an active participant with AFSP-AR for several years through their Out of the Darkness Community Walks.


Max has been a leading voice at his high school, specifically with the Friends of Rogers student group. This group was created by Max, Keri Book, and several students who noticed a need for a student group that focused on mental health awareness. In his role with the Friends of Rogers group, Max helped chair the Rogers School District’s Out of the Darkness Campus Walk last year (2023), raising $265 dollars for AFSP. Max also participated in the Arkansas State Capitol Day event, where he met with legislators to advocate for 988 and smart mental health legislation. During his time with Friends of Rogers, the group saw a student count of 100 students involved. Max also assisted the Suicide Prevention Resource Center (SPRC) on updating the National Strategy for Suicide Prevention.

Max’s Dad, Jorge Delgado shared his enthusiasm for his son’s accomplishments and the impact that Max has had on his community and his younger brother: “Thank you for recognizing my son’s passion to help kids suffering with mental health. Besides what Ms. Jackie Sharp [from the AFSP-AR] told you about my son, I wanted to add that he is also a great big brother to my youngest son, JD. Max has set a great example for JD [a sophomore at Rogers HS], helping JD become more involved in AFSP and in Friends of Rogers. This winter, Max and the Friends of Rogers put together one hundred care packages for the homeless.”


Max’s passion for his community coupled with his role in Friends of Rogers has allowed him to grow as a leader and resource to his peers. Before graduating, Max wanted to prepare the next ardent group of leaders, which includes his younger brother JD, to ensure continued success at Rogers High School. Max is an incredible young man and his peers and teachers believe his zeal for mental health advocacy will only continue to thrive.


Max will be attending University of Arkansas in the fall, majoring in psychology. He will be starting as a junior as a result of earning his associates degree while dual enrolled at Rogers High School.


Congratulations, Max! Keep up the incredible work you do!

********

Thank you to all that participated in this year's program, including the phenomenal Award Selection Committee: Leslie Franceschi (chair), Matthew Shapiro, NAMI-NYS, Sara Swanson, WCG, and Allie Freitas, Boehringer!

What is the real impact of TD on patients?


Check out this series of interviews based on the data from Teva's IMPACT-TD Registry, the largest-ever study of its kind evaluating the holistic effects of TD over three years. Findings show that nearly 98% of patients experience quality of life impact as a result of TD including social, psychological, physical and recreational aspects of daily living and highlight for the first time that TD has a multidimensional impact on patients including those with mild TD severity.

PSAs for Mental Health Research

Let's all post monthly Public Service Announcements

for Mental Health

Clinical Research.


Most of you post announcements for specific trials that you are recruiting for, but what if everyone reading this posted a monthly or bimonthly PSA on mental health clinical trials?


We love NTXCT's post (right-->)

and were inspired to create, collect, and set up a library of general mental health clinical research graphics for everyone to use and share.


Do you have any PSAs that you use? tag us and we'll like and repost!

Reflecting on history, I am filled with appreciation and a sense of pride as I join the STARR Coalition in commemorating Pride Month. As a member of both the clinical trial industry and the LGBTQ community, I am keenly aware of the challenges and barriers that individuals within this diverse community often face.

The intersectionality of being LGBTQ and working in clinical trials presents a unique opportunity to approach research with a blend of varied perspectives and personal experiences. However, it is crucial to acknowledge that members of the LGBTQ community encounter disparities and discrimination in healthcare settings, which can hinder their access to clinical trials and optimal care.

In order to truly reflect the rich diversity of patient populations, the clinical trial sector must actively embrace LGBTQ individuals within its workforce. By fostering a team that represents different backgrounds and identities, we can ensure that clinical trials are conducted with inclusivity and sensitivity towards the specific needs of LGBTQ participants.

Championing compassion, insight, and authentic representation in our research practices is essential to crafting trials that cater to the unique healthcare requirements of LGBTQ individuals. By dismantling barriers and promoting a culture of acceptance and understanding, we can advance healthcare outcomes for all, regardless of sexual orientation or gender identity.

The American Brain Coalition (ABC) signed a letter from NDD United calling on Congress to reject arbitrary non-defense discretionary (NDD) funding levels and instead provide sufficient NDD funding to support the array of critically important programs, including biomedical research and public health programs, across the federal government.



Please consider joining the letter and sharing it with your networks. The letter is open to national, state, and local organizations.


Deadline to sign is Friday, June 21. Review and sign here.

Differential outcomes of placebo treatment across 9 psychiatric disorders: a systematic review and meta-analysis. This study posed the question of which psychiatric disorder exhibited the strongest improvement associated with placebo treatment in randomized clinical trials (RCT)? This systematic review and meta-analysis of 90 high-quality RCTs with 9985 participants found significant improvement under placebo treatment for all 9 disorders, but the degree of improvement varied significantly among diagnoses. Patients with major depressive disorder experienced the greatest improvement, followed by those with generalized anxiety disorder, panic disorder, attention-deficit/hyperactivity disorder, posttraumatic stress disorder, social phobia, mania, and OCD, while patients with schizophrenia benefited the least.


Study suggests that mental disorders might be socially transmitted within adolescent peer networks. In this cohort study including more than 700 000 individuals in Finland, analysis of nationwide, interlinked registry data found that having classmates diagnosed with a mental disorder in the ninth grade of comprehensive school was associated with increased risk of receiving a mental disorder diagnosis later in life. Increased risk remained after adjusting for an array of parental, school-level, and area-level confounders.



Teva Pharmaceuticals and Medincell shared new results from the efficacy portion of the phase 3 subcutaneous olanzapine extended-release injection study (SOLARIS) trial evaluating TEV-‘749 in adult patients with schizophrenia. TEV-‘749 met its primary endpoint, achieving clinically meaningful and statistically significant reductions across all TEV-‘749 dose groups compared with placebo in the Positive and Negative Syndrome Scale (PANSS) total score from baseline after 8 weeks.



Teva presented the first real-world data from their IMPACT-TD Registry study at Psych Congress Elevate 2024. The IMPACT-TD Registry is the largest-ever study of its kind evaluating the holistic effects of TD over three years along with real-world treatment patterns and outcomes with once-daily AUSTEDO® XR (deutetrabenazine) extended-release tablets and twice-daily AUSTEDO® (deutetrabenazine) tablets.


Intra-Cellular Therapies presented positive data from Study 403 on Lumateperone for MDD and Bipolar Depression With Mixed Features. The results of the study demonstrated that lumateperone significantly improves symptoms in this patient population, highlighting the efficacy and safety of the treatment compared with placebo. In the combined population of patients with MDD or bipolar depression experiencing a depressive episode with mixed features, 385 patients received treatment, and 383 (191 on placebo and 192 on lumateperone) were included in the modified intent-to-treat (mITT) population. Most patients (89.4%) completed the treatment.


New Data Demonstrates KarXT’s Positive Long-Term Metabolic Profile: According to new data, KarXT (xanomeline-trospium) shows a positive long-term metabolic profile in adults with schizophrenia, with patients experiencing metabolic stability or improvements over a 52-week course of treatment. “Unlike current schizophrenia treatments that are often associated with a variety of adverse events such as weight gain and hyperlipidemia, KarXT offers a new and unique mechanism of action that does not directly block dopamine receptors,” said Dr. Rishi Kakar, Chief Scientific Officer and Medical Director of Segal Trials. The phase 3 EMERGENT program data revealed significant weight reductions and stable metabolic parameters, positioning KarXT as a promising new treatment for schizophrenia.

Most detailed 3D reconstruction of human brain tissue ever produced yields surprising insights. In the new study, supported in part by the NIH BRAIN Initiative and reported in the journal Science, researchers have created the most detailed nanoscale resolution map ever produced of a cubic millimeter of brain tissue, about the size of half a grain of rice. Despite its small size, this fragment of healthy brain contained about 57,000 cells of various types, 230 millimeters of blood vessels, 150 million neural connections, or synapses, and the protective myelin that insulates neurons. To capture it all in vivid detail, the researchers relied on electron microscopy to amass an impressive 1,400 terabytes of imaging data.

Boehringer Ingelheim hosted a "Look Beyond Stable" installation a short walk from the Javits Center, where the 2024 APA Annual Meeting was held. The installation seeks to raise awareness on the reality of living with schizophrenia for both mental health clinicians, caregiver, and the general public.


Boehringer added the STARR's Auditory Hallucination Simulation to the installation at ISPOR in Atlanta - the first of which we hope will be a regular component of the installation!


Adolescents with MDD were found to be more than 50% less likely to transition early to Bipolar Disorder (BD) compared with adults. There was a notable reductions in inpatient care and antidepressant use following BD diagnosis for both groups and without an increase in lithium prescriptions.


Precision medicine and novel approaches are on the cusp of breaking through in psychiatry. The psychiatric field is gaining momentum with late-stage trials for new depression treatments on the horizon, sparking hope for precision medicine. Current treatments, mainly SSRIs and SNRIs, are widely used but often inadequate, with a significant portion of the population still struggling with depression. Innovators like Alto Neuroscience and Janssen are shifting towards therapies targeting specific symptoms and biomarkers, aiming for a more personalized approach. This precision method contrasts with traditional broad-spectrum treatments and could lead to more effective care.


AbbVie has entered a collaboration and option-to-license agreement with Gilgamesh Pharmaceuticals to enhance psychedelic therapies for psychiatric disorders. This partnership allows AbbVie to access Gilgamesh’s novel therapies portfolio and lead development and commercialization activities for select programs. Gilgamesh’s proprietary platform, integrating behavioral assessments, electrophysiology, and AI, aims to create effective psychiatric treatments with minimal side effects. This collaboration underscores the growing industry focus on innovative psychiatric therapies, with other companies like Reunion Neuroscience and MindMed also advancing in this field.


Public Citizen has sued the FDA to mandate that drugmakers include warnings about long-term sexual side effects of SSRIs and SNRIs. The lawsuit, filed in the US District Court for the District of Columbia, argues that the FDA has delayed a decision on a citizen petition from doctors requesting these warnings. Current labels mention sexual side effects during use but not persistent issues after discontinuation. Public Citizen claims this lack of information prevents patients and healthcare professionals from making informed decisions about these drugs. Regulatory agencies in Canada and Europe have already required similar warnings. The lawsuit seeks a court order for the FDA to respond to the petition within 30 days, highlighting the urgent need to inform the public about these potential risks.

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.

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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