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September is
Suicide Prevention
Month
Suicide Prevention Month is dedicated to addressing the difficult topic of suicide. Bringing awareness can help to provide resources for those in need and their loved ones, give communities tools and education, continue research and innovations, and support policy work.
National Suicide Prevention Week takes place September 8-14, with World Suicide Prevention Day on September 10th.
Since 2002, millions of people have attended the American Foundation for Suicide Prevention’s OUT OF THE DARKNESS WALKS in communities across the country, raising awareness and funds that go toward education programs, advocacy efforts, and scientific research that reveals how we can save more lives. Find an Out of the Darkness Walk near you, as we all take a step in the right direction: towards HOPE.
SAMHSA offers the following information to help educate yourself and others about suicide prevention: Learn the warning signs and risk factors for suicide, how to support someone considering suicide, and familiarize yourself with the 988 Suicide & Crisis Lifeline.
The Suicide Prevention Resource Center (SPRC) created a resource full of ways to get involved in Suicide Prevention Awareness Month. Here is the resource for 2024!
Read and share the 2024 National Strategy for Suicide Prevention and Federal Action Plan.
Suicide prevention is important every day of the year. National Suicide Prevention Month gives us an opportunity to shine a special, encouraging light on this topic that affects us all, and send a clear, hopeful message that help is available, and suicide can be prevented.
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The CenExel RCA team joined forces to help our South Florida community donating to a Back-to-School Campaign. This campaign helps hundreds of children in our community to have the tools they need to succeed. Backpacks and school supplies were donated to children residing in their centers, which serve the homeless and needy of South Florida. We are delighted to help our kids start the school year on the right foot! The Caring Place coordinated and hosted the event, where Cecily Hernandez, RCA Community Partnership Manager and campaign coordinator, delivered their supplies.
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Pillar Clinical Research Richardson, TX team recently completed the Crisis Prevention Institute (CPI) Nonviolent Crisis Intervention Training with Milan McDaniel, QBHP, Director of Program and Operations of Inspirations Day Treatment in Little Rock, AR (pictured). The Crisis Prevention Institute's Verbal Intervention (VI) Training program teaches staff how to respond to low-risk crises using verbal de-escalation techniques. The program is ideal for organizations with hands-off policies or staff who don't typically deal with situations that require physical intervention. CPI training is coming to the other Pillar sites soon!
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Midwest Clinical Research Center, part of the ERG group, in Dayton, Ohio (sadly, one of the hot spots in the country for opioid addiction), is proud to be a sponsor for several awareness events in the area. The Montgomery County Prevention Coalition held a community event for Overdose Awareness at Levitt Pavilion August 14th with a DJ, free food, and many of area providers sharing resources. The Cincinnati Addiction Council held their Overdose Awareness event August 30th which MCRC is proudly sponsoring. There will be an Addiction Resources event September 21st in Dayton hosted by RAMCO/Dayton Public Health where MCRC will be sharing information on the Opioid Addiction Trials we have enrolling.
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Another great event that Midwest participates in is the FOA (Families of Addicts)11th Annual Rally at Courthouse Square on August 25th with a tremendous turnout of over 60 vendors sharing services. MCRC takes these events very seriously and work hard to make sure that the community is aware of the resources available to them at MCRC. In addition to the organized Awareness events, we also participate in monthly street outreach in Dayton and Cincinnati, sharing resources, snacks, and hygiene bags. We love our community!
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The CenExel iResearch and CenExel ACMR sites have established a state-of-the-art PET Scan Unit in Atlanta. Both of the CenExel Atlanta sites will utilize the PET Scan Unit, which has been specifically designed to enhance clinical research imaging. This new facility will drive groundbreaking discoveries and elevate patient care across the CenExel Atlanta Centers of Excellence.
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The CNS Healthcare Memphis site volunteered at the Mid-South Food Bank! They had a "SPUD-TACULAR" time sorting 6000 lbs of potatoes and packing them into smaller containers which will be going to help hundreds of families in need across the mid-south!
The Mid-South Food Bank is committed to delivering nutritious and wholesome food to local agencies and distribution sites across 31 counties! CNS Healthcare is proud to help support their outstanding efforts providing assistance to those facing food insecurity every day.
GO TEAM MEMPHIS! ❤
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Clinical research is a public necessity and those who contribute are performing a crucial public service. So, why are we making it harder for people to contribute? | |
In February 2024, "The Harley Jacobsen Clinical Trial Participation Income Exemption Act" (H.R. 7418) was introduced in the House. The bi-partisan bill, co-sponsored by PA Congressional leaders Mike Kelly (R) and Chrissy Houlahan (D), seeks to exclude all payments to participants in clinical trials from being treated as taxable income. | |
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The Harley Jacobsen Clinical Trial Participant Income Exemption Act aims to:
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- Eliminate the reporting requirements for both the patient/caregiver and the 1099 reporting requirement of the payor. This will protect participants who rely on social welfare programs such as SNAP, WIC, and others from exceeding income requirements.
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- Increase diversity of the enrolled-patient populations across all trials, aligning with the strategic goals of the NIH and FDA.
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- Provide greater access to experimental therapies to the least-empowered Americans (those with disabilities, minority populations, chronic physical illness, low-income populations, low-education level, etc.).
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The Impact of Taxation for Recipients of Low-Income Subsidies:
Many living at or below the poverty line rely on social welfare programs. By treating clinical trial payments as taxable income, we are deterring participation by those who rely on public assistance because eligibility for these programs is typically based on an individual’s gross and net income and available resources.
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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.
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This is a long process, but well worth the effort. The more support we rally, the sooner we can enact change.
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Resources:
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Why Are We Supporting the
Harley Jacobsen Act over the
Clinical Trial Modernization Act?
The Clinical Trial Modernization Act limits the amount excluded from gross income to $2,000.
Psychiatry trials are the highest paid trials with larger than average payments and larger completion bonuses due to the nature of these studies, including in-patient study requirements.
Not only would the Clinical Trial Modernization Act not help with psychiatry trial participation, but it could actually hurt these trials by causing the payments to be reduced.
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988 Day is a national initiative dedicated to raising awareness about the 988 Suicide & Crisis Lifeline and emphasizing the importance of mental health and suicide prevention. Join us on September 8, 2024, in sharing the theme "No Judgment. Just Help" and visit SAMHSA's 988 Day page for materials, tools, and ideas to support your own promotional efforts and activities on 988 Day.
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September is National Recovery Month
September is also National Recovery Month (Recovery Month), which started in 1989 and is held every September to promote and support new evidence-based treatment and recovery practices, the recovery community, and the dedication of service providers and communities who make recovery in all its forms possible.
This month, share resources with your network to support Resilience and Recovery from mental health and substance use challenges. On SAMHSA's Recovery Month website, you'll find events to raise awareness and access a toolkit with social media shareables, newsletter articles, and other content to share with your network.
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1,759. That’s how many children between ages 8 to 12 died by suicide between 2008 and 2022, up from 482 children between 2001 through 2007.
Data released Tuesday by the National Institute of Mental Health shows the increase is disproportionately high among girls 8 to 12 years old.
In 2022, the American Academy of Pediatrics urged health-care providers to screen all teenagers for suicide risk, despite national recommendations saying more research is needed to assess the benefits and harms of such screenings.
Some experts maintain that broadening the screening guidelines could identity higher-risk patients at an earlier age.
Horowitz said the study released Tuesday highlights the importance of starting screenings earlier.
“We have to dispel that myth that talking about suicide puts the idea into someone’s head,” Horowitz said. “There are at least four studies now showing that it’s actually the opposite, that it’s not dangerous to ask kids about suicide risk. It actually could save their lives.”
Source: https://www.washingtonpost.com/health/2024/07/30/suicide-rates-increasing-children-preteen/
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Teva's IMPACT-TD Registry is the most comprehensive study of its kind
evaluating the holistic effects of TD over three years.
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Successfully enrolled 629 patients into the largest study to date on Tardive Dyskinesia - IMPACT-TD Registry.
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The study population includes broad representation of people affected by TD according to age, race/ethnicity, severity of movements and underlying mental health conditions.
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More data analyses are being conducted with plans to present this Fall.
Teva remains highly interested in feedback from people living with illness
on how TD truly impacts their life. This study should help us understand more.
Learn more here and here! and here!
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Each September, people from all corners of the world unite to raise awareness of Alzheimer’s disease and all types of dementia.
World Alzheimer’s Month is an international campaign to raise awareness and challenge stigma of Alzheimer's and dementia. Alzheimer’s disease is the most common form of dementia, affecting about 6 percent of people 65 and older.
With the number of people living with dementia set to almost triple by 2050, it has never been more important to recognize the risk factors associated with dementia and take proactive steps towards risk reduction. As such, this year’s theme ‘Never too early, never too late’, centers on the key risk factors and risk reduction, aiming to emphasize their crucial role in delaying and potentially preventing the onset of dementia. This also importantly includes ongoing risk reduction for those who have already been diagnosed.
World Alzheimer’s Day takes place during World Alzheimer’s Month and is on September 21st every year. In the build up to, and on the day of, many Alzheimer and dementia associations around the world host memory walks, fundraisers, awareness raising activities and campaigns to bring attention towards those in their community that are affected by Alzheimer’s disease or other types of dementia.
For more information and a list of ways for you to show your support, visit this site or this one.
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New Method Tracks How Psychedelics Affect Neurons in Minutes. Researchers at the University of California, Davis have developed a rapid, noninvasive tool to track the neurons and biomolecules activated in the brain by psychedelic drugs. The protein-based tool, which is called Ca2+-activated Split-TurboID, or CaST, is described in research published in Nature Methods.
Which psychiatric disorder exhibits the strongest improvement associated with placebo treatment in Randomized Clinical Trials? A 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. The findings may inform planning of RCTs, interpreting of uncontrolled studies, and advising patients for or against a specific treatment.
Study finds association between body mass index (BMI) and mental health among adolescents. The study analyzed more than 1 million adolescents, aged 11 to 15 years, from Europe and North America, and found a consistent U-shaped association was found between BMI and mental health, which grew stronger over time. The increasing association between BMI and adolescent mental health over time underscores the urgency for tailored interventions targeting body image and well-being.
Short sleep duration over a prolonged period in childhood could have a detrimental impact on long-term mental health, including the development of psychosis. In this cohort study including 12,394 children and 3962 young adults, a group of individuals characterized by persistent shorter sleep duration from infancy until childhood were identified, and this group was significantly associated with psychosis at age 24 years. Further, elevated interleukin 6 (IL-6) levels at 9 years partially mediated these associations.
Recent evidence suggests a more rapid deterioration of the timeliness and quality of postdischarge follow-up mental health care in rural areas than in urban areas. Overall, rural and urban inpatient readmission trends were stable between 2016 and 2020. However, for index mental health stays, rural and urban readmission rates trended in opposite directions: the 30-day all-cause readmission rate increased from 14.74 per 100 index stays in 2016 to 16.17 in 2020 for rural mental health stays, whereas it decreased from 16.96 per 100 index stays to 15.75 during the same period for urban mental health stays.
A study of 636 patients over their course of care in an early intervention service for psychosis found that patients had high rates of remission, low rates of relapse, and decreased overall symptoms during the course of treatment following a first episode of psychosis. The minority of patients who did relapse experienced similar delusion themes to their index episode and a consolidation into fewer themes during subsequent episodes. This indicates that as the delusion content remained consistent across episodes of psychosis, there is relevance for recognition of early warning signs and relapse prevention, and suggests a need to maintain, rather than reduce, the intensity of interventions across the entire follow-up period in early intervention settings.
Neurocrine's daily oral therapy NBI-1117568 hit its main efficacy targets in the phase 2 trial, with a statistically significant reduction from baseline in the Positive and Negative Syndrome Scale (PANSS) total score after six weeks compared to placebo. The size of the reduction in PANSS – a 7.5 improvement on placebo and an 18.2-point fall from baseline – was lower compared to similarly-acting rival therapies in late-stage development from Bristol-Myers Squibb and AbbVie.
FDA’s Lykos rejection delays - but doesn’t stop - psychedelic therapies. Players in this up-and-coming therapeutic space see the rejection as a sign of caution from the FDA, offering broader lessons, not a reflection of resistance to the ideas of psychedelic therapies.
Atai touts early data on psychedelic depression drug, plans Phase II trial. Atai Life Sciences said Tuesday its psychedelic depression drug candidate generated positive preliminary results in a Phase Ib trial, positioning the biotech to start studying the molecule in patients this year. The candidate, VLS-01, is an oral formulation of N,N-dimethyltryptamine (DMT). Applied to the lining of the cheek, the investigational treatment is designed to induce a short psychedelic experience that helps people with treatment-resistant depression. The active ingredient is different from those used in Lykos Therapeutics’ recently rejected MDMA candidate and Compass Pathways’ psilocybin treatment.
A review and meta-analysis of antipsychotic dose-response literature suggests that the maximum target doses of antipsychotics in approved labeling are unnecessarily high, with less gain in efficacy than in adverse effects. This article provides the peak effective dose, current daily maximum (per British National Formulary), and the daily maximum recommended by the authors for several selected agents in use in the US and UK.
Approximately 1 in 3 patients do not have an adequate response to first-line antipsychotics and have treatment-resistant schizophrenia (TRS). Clozapine is the most efficacious antipsychotic for patients with TRS, however, clozapine is also associated with a significant burden of severe adverse drug reactions (ADR), including neutropenia, myocarditis, and gastrointestinal hypomotility, with almost 97% of participants reported experiencing 1 or more clozapine-associated ADRs, with a mean number of over 5 ADRs.
Esmethadone (REL-1017) did not meet the primary endpoint outcome in the recently published phase 3 trial as an adjunct for major depressive disorder (MDD), despite following on phase 2 results which had been characterized as "robust." However, favorable findings on secondary measures and in subsequent analysis were sufficient to warrant an additional phase 3 trial which is currently underway.
Selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressants were deemed the safest classes of antidepressants in the event of excess dosing in an assessment of 14 antidepressants prescribed in the United States on 3 safety indices. Poliacoff extracted data on antidepressant-related deaths, major adverse events, required treatment in health care facilities, and prescription quantity for the period between 2013 and 2020 from the NPDS and the Agency for Healthcare Research and Quality’s Medical Expenditure Survey. In total, the sample comprised 364,526 single-agent exposures and more than 1,844,877,361 prescriptions.
Evidence indicates that children and adolescents with ADHD have a more than 4-fold increased risk of schizophrenia spectrum and other psychotic disorders in adulthood compared with the general population. Additionally, ADHD is associated with worse clinical, social, occupational, and treatment outcomes among individuals with SZSPD. It has been unclear whether the risk of psychotic relapse among individuals with SZSPD is higher when they are treated with ADHD medications, including amphetamines, methylphenidate, and atomoxetine.
The FDA has approved Luye Pharma’s paliperidone palmitate (Erzofri) extended-release injectable suspension for the treatment of schizophrenia in adults and schizoaffective disorder in adults as monotherapy, as well as an adjunct to mood stabilizers or antidepressants. Administered once monthly, Erzofri is the first patented paliperidone palmitate long-acting injection developed in China to get approved in the US. In 2023, the product was granted a US patent which will expire in 2039. Erzofri is the second long-acting injectable paliperidone palmitate product to receive FDA approval. Janssen's monthly injectable formulation, Invega Sustenna, received approval in 2009, followed by its 3-month formulation (Invega Trinza) and 6-month formulation (Invega Hafyera).
Cannabis use during adolescence can profoundly impact brain development. The brain develops until age 25, with evolution in gray and white matter. In adolescence, gray matter diminishes while white matter increases, impacting cognitive development. The link between cannabis use and the onset of psychosis has long been an area of interest and speculation. Observational studies have consistently pointed to an association between cannabis use and schizophrenia; however, the nature and mechanisms of this relationship remain poorly understood. The perceived risk of harm from cannabis has decreased over time and the concept of cannabis as a medicine is gaining traction.
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Access the MUST WATCH webinar that explains the IRA drug price-setting provisions and discusses its negative impact on access to mental health treatments for patients and what you can do to prevent this unintended consequence. | |
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Calling all Sites!
Do you have patients that are interested in learning more about being a Peer Specialist? Let them know about DBSA's webinar on Sept. 10th!
DBSA is hosting a Peer Specialist Training. Join Douglas Hulst CPRS-IL, DBSA Peer Recovery Workforce Development Senior Program Manager for a virtual Q&A session on September 10th!
For more information and to register, click here.
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2024 American Neurological Association Annual Meeting (ANA2024) will be held from September 14-17, in Orlando, FL. The ANA’s 149th Annual Meeting will convene the nation's top academic neurologists and neuroscientists. The Meeting will feature six main symposia, which highlight groundbreaking conceptual and therapeutic advances in a variety of neurologic disease states, as well as interactive lunch workshops, special interest group sessions, and poster sessions.
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MHACon 2024 will be held Sept 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.
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The APA's 2024 Mental Health Services Conference is taking place in Baltimore, MD, Sept. 26-28. The 2024 Mental Health Services Conference will bring psychiatrists and other mental health professionals together to collaborate on practical advice to influence systems-level change for their patients. Connect and collaborate across the mental health services team and find practical ways to integrate new research and treatment strategies into clinical practice; identify barriers to care, including health service delivery issues, recognize and improve mental health disparities in the community, and more.
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ANA2024 will be held Sept 14 – 17 in Orlando, FL. The Annual Meeting has been designed to foster discussions among investigators in academia, industry, and foundations toward the common goal of furthering translational science. As usual, it will include professional development workshops offering daily sessions designed for early career, mid-career, and residency directors.
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The Global Site Solutions Summit will be held from Sept. 27-29 in Hollywood, FL. The 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. Whether your priority is networking with sponsors and CROs or learning best practices built for research sites, the Summit will provide a valuable experience for your business.
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Neuroscience 2024 will be held Oct. 5-8 in Chicago. Each year, scientists from around the world congregate to discover new ideas, share their research, and experience the best the field has to offer. Attend so you can: present research, network with scientists, attend session and events, and browse the exhibit hall. Join the nearly half a million neuroscientists from around the world who have propelled their careers by presenting an abstract at an SfN annual meeting — the premier global neuroscience event.
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SWP'24 Conference is being held at Yale University October 18-20! This hybrid event has virtual and in-person ticket options. Students With Psychosis is proud to partner with Mindmap and The Women's Mental Health Conference at Yale to make this event possible. Join us for a conference of learning, community-building, and celebrating what people living with psychosis can achieve when given the proper resources and support. Meet industry leads, renowned authors, social media influencers, mental health advocates, researchers, fellow SWP students, and their families as we hear from different viewpoints coming together to formulate new ideas for an insightful discussion. To learn more about Students With Psychosis, visit www.sws.ngo.
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Save the Date: The 2024 International Mental Health Research Symposium will be held virtual and in-person Friday, October 25th in New York City. Join the Brain and Behavior Research Foundation for presentations on leading research discoveries across brain and behavior disorders by the Foundation’s 2024 Outstanding Achievement Prizewinners and the Pardes Humanitarian Prizewinner.
More information coming soon.
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Psych Congress is the nation's conference on practical psychopharmacology and a community of passionate mental health clinicians. The 37th annual Psych Congress will be in Boston from Oct. 29 - Nov. 2. This year, the Schizophrenia & Psychosis Action Alliance (SPAA) is partnering with Psych Congress to bring two special sessions: A Primer on Negative Symptoms and Cognitive Impairment in Schizophrenia and a session on Long-Acting Injectable Anti-psychotics. Members of the SPAA community can use code SPAA for a $50 discount on registration. Find more info here.
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The National Federation of Families National Conference is Nov. 7-9 in Orlando, FL. NFF brings together families, parents, community leaders, providers, partners, and legislators at the Annual Conference and 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.
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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.
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Thank you for reading!
If you have questions, comments, or would like to submit an item to be included in an upcoming newsletter, please email erica@thestarr.org.
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The STARR Coalition | phone: 501-725-8890 | www.thestarr.org
SHARE, CARE, AND BE KIND.
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