Interventions: Drug: Psilocybin; Behavioral: Psilocybin-Assisted Therapy With Dialectical Behavior Therapy
Sponsors: University of Minnesota; Filament Health Corp.
Not yet recruiting
Background: Rejoyn (CT-152) is a prescription digital therapeutic (DTx) adjunct to antidepressive medication authorized for patients with major depressive disorder. To better understand the patient benefit of DTx and other treatment modalities, current regulatory standards support the use of modern psychometric methods to interpret the clinical meaningfulness of treatment effects for patients. In the primary analysis of Rejoyn from the pivotal phase 3 Mirai trial (NCT04770285), Rejoyn showed a broad risk-to-benefit profile as demonstrated on multiple clinician- and patient-rated scales, including the primary efficacy outcome measure, the Montgomery-Åsberg Depression Rating Scale (MADRS). These findings supported US Food and Drug Administration authorization of Rejoyn as a prescription DTx. However, the clinical relevance of these changes in the MADRS score is not immediately interpretable in clinical practice. Here, we present the results from several post hoc analyses of the Mirai trial data to support the interpretation of clinically meaningful treatment differences on clinician- and patient-reported change in depressive symptoms. Objective: This study had two main objectives: (1) establish threshold parameters that allow for clinically meaningful interpretation of the Mirai results in clinical practice, based on the clinical trial end points of change from baseline in depressive symptoms, and (2) apply this threshold in a responder and sensitivity analysis in the intent-to-treat (ITT) population (which is more frequently reported in pharmacological trials) to further support the interpretation of change in unblinded analysis of the Mirai results. Methods: For the Mirai meaningful within-patient change (MWPC) analysis, anchor-based methods were used to define an MWPC threshold by exploring the associations between the MADRS and the clinician-rated Clinical Global Impression-Severity Scale (CGI-S) and the patient-reported Patient Health Questionnaire 9-Item Scale (PHQ-9). Additional post hoc efficacy analyses (including that of responders) are reported for the ITT population. Results: Using the MWPC thresholds of 8 and 10 points (derived with the CGI-S and PHQ-9 as anchor measures, respectively), the distribution of MADRS responders favored the Rejoyn group over the sham group, and the Rejoyn group had 24%‐47% higher odds of meaningful improvement on the MADRS. Post hoc ITT analyses also favored the Rejoyn group over the sham group for response rates and PHQ-9 and CGI-S score change from baseline. Conclusions: Results are consistent with the primary findings of the Mirai trial, supporting the efficacy of Rejoyn as an adjunctive treatment to antidepressive medication monotherapy for adults with major depressive disorder. The MWPC analyses offered a measure of meaningful change on the MADRS, providing a framework of clinical meaningfulness for the Mirai trial findings.
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Hello there and welcome to a new week. STAT reporter Andrew Joseph here in London filling in for Mr. Pharmalot for the day. Before we get to the headlines, an extra dose of encouragement to check out all the great pieces that STAT has to offer today, from Reed Jobs opining on the NIH budget to our new trust-in-science reporter Nick Florko outlining his own experience grappling with, as he puts it, “how frustrating it is to realize that modern medicine does not have all the answers.” Now to those headlines. …
Novo Nordisk is seeking to assure investors that it can regain its momentum in the coming years, outlining plans to expand its pipeline and find new products that it could sell more like consumer goods than traditional medicines, building off what’s occurring with its obesity treatments, STAT shares. At the company’s capital markets day in London, CEO Mike Doustdar said Novo would launch at least five multi-blockbusters by 2030 and deliver revenue growth on par with other major pharma firms. He also presented a strategy that involved investing more in disease areas outside diabetes and obesity and said the company “will be more active within business development,” an acknowledgment of investors’ concerns that Novo was too reliant on its landmark GLP-1 drugs and needed to develop other products.
Drugs called orexin agonists have been hailed for their ability to treat rare sleep disorders, but with new data, Alkermes is showing for the first time that the new class of therapies may benefit people with ADHD, STAT writes. In a randomized Phase 1 study, the company’s new drug, called ALKS 7290, was well tolerated and showed a signal of efficacy. Participants in the study started with a median score of 39 on a diagnostic known as the Adult ADHD Investigator Symptom Rating Scale, indicating that they had moderate to severe symptoms. After two weeks, those taking a high dose of 50 milligrams of ALKS 7290 experienced a 19-point reduction on the scale, indicating that their symptoms had become mild.
By Emma Beckwith, 2026 Youth Mental Health Academy Intern, Child Mind Institute
As mental health care, education, and research for youth advances, it is important to remember that in order to best serve young people, we must listen to their lived experience. They know better than anyone what conversations and changes need to happen to improve child and adolescent mental health care around the world. Therefore, they must be included in this discussion as co-creators and leaders of transformation.
Building on the momentum of last year’s inaugural Global Summit on Youth Mental Health, the Stavros Niarchos Foundation (SNF) Global Center for Child and Adolescent Mental Health at the Child Mind Institute will host the second edition of the annual event on September 21-24 in New York City.

Led by the SNF Global Center’s Global Youth Advisory Council (GYAC), the event is set to unite young people from around the world to discuss the issues impacting their mental health. Additionally, clinicians, researchers, and policymakers will participate in various sessions. The hope is that youth and adult experts can work together to enact necessary changes in child and adolescent mental health care.
The GYAC, consisting of members from the Global Center’s Child and Adolescent Mental Health Initiatives (CAMHI) in Greece, Brazil, and South Africa, took on a leading role in organizing the summit. In every step of the process, they have had input on what they want the summit to look like, new features they want to include, the key topics that will be discussed, as well as the theme for this year’s summit: “Redefining Mental Health Care: Youth Perspectives in a Changing World.” They will also serve as moderators of discussion panels, with each GYAC member leading conversations on topics they feel passionate about.
The youth are the present and future and deserve to be the lead contributors in this work. This year, the summit aims to center their voices through three thematic sessions:
During last year’s summit, young participants came together to document key takeaways and actionable items for implementation and global change through a published youth-led report. This year, the goal is to increase youth involvement even more, with more youth attendees, speakers, and leaders. After all, this event isn’t just for the betterment of youth and adolescent mental health, but a space for people around the world who have a shared passion and care about this issue to connect and unify in order to enact positive change.
As a young person myself, what I would like to see come out of this year’s summit is action. The event is already an amazing starting point, where both young people and adults have shown their care for improving child and adolescent mental health. Now, we need to take actionable steps to implement the changes needed as voiced by youth, so that the talk doesn’t just stay within the event but becomes a reality. While there is no doubt that it will take time, I have hope that with the continuation of these annual summits, more global experts, changemakers, policymakers, clinicians, researchers, and caretakers will take what they’ve learned into their spaces of work to enact real change.
As Nelly Serdari, a member of the Youth Engagement Scheme (YES) with CAMHI in Greece, stated at last year’s summit, “The only way that we can try to break down barriers is if older generations try to get on our level.”
Now, it is up to the adults to break down the barriers that we youth cannot.
Learn more about the inaugural Global Summit on Youth Mental Heath
Learn more about the Youth Mental Health Academy at the Child Mind Institute
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