Psilocybin-facilitated Treatment for Chronic Pain (Observational, University of Alabama at Birmingham, n=30, recruiting) — The primary purpose of this study is to preliminarily estimate the efficacy of psilocybin-facilitated treatment for fibromyalgia.…
Mindfulness-Assisted Psychedelic Therapy (Phase 2, University of Southern California, n=40, recruiting) — The goal of this clinical trial is to test psilocybin in combination with mindfulness training in healthy adults.…
MDMA-Assisted Therapy NDA Resubmitted to FDA for PTSD (Regulatory, approved) — Lykos Therapeutics resubmitted its New Drug Application (NDA) to the FDA for MDMA-assisted therapy for PTSD. The FDA had previously issued a Complete Response Letter regarding the application.
Ketamine Associated ACC GABA and Glutamate Change and Depression Remission: (Observational, Mayo Clinic, n=18, active) — This is a feasibility study and the goal of this project is to evaluate whether peak ACC GABA and glutamate, quantified as a CSF-corrected absolute concentration percent change from baseline, is associated with clinical remission, Montgomery Asberg Depression Rating Scale (MADRS) total score of \<10, to the anti-glutamatergic antidepressant ketamine.…
Treatment Study of Bipolar Depression (Observational, Icahn School of Medicine at Mount Sinai, n=1, completed) — The purpose of this study is to determine whether a single intravenous administration of an N-methyl-D-aspartate antagonist is safe and effective for the acute treatment of bipolar depression.
Ketamine-Induced Brain Changes and Their Modulation by Lamotrigine (Observational, Charite University, Berlin, Germany, n=75, completed) — This study is firstly designed to investigate acute and delayed effects of a single dose of ketamine on functional brain changes during emotional and cognitive challenges and at rest.…
Ketamine Treatment for PTSD and MDD in TBI (Phase 2, Minneapolis Veterans Affairs Medical Center, n=40, recruiting) — The goal of this clinical trial is to examine the use of sedative ketamine to treat depression and post-traumatic stress disorder (PTSD) in Veterans with mild to moderate traumatic brain injury (TBI).…
Anhedonia, Development, and Emotions: Phenotyping and Therapeutics (Observational, Erika Forbes, n=123, completed) — The goal of the ADEPT Study is to understand anhedonia in young people and how it changes based on treatments targeting the brain circuit underlying it. Anhedonia is a challenging mental health symptom that involves difficulty with motivation to experience pleasant events.…
InTRavenous kEtAmine and immerSive virtUal Reality to Treat dEpression (Phase 3, Sunnybrook Health Sciences Centre, n=31, recruiting) — Depression is a common condition, with serious negative effects on the health and quality of life of those affected. While there are currently various medications which attempt to treat depression, they often take a long time to begin to work and do not work at all for many people.…
Behavioural Activation Therapy and Ketamine for Treatment-Resistant Depression (Phase 2, The Royal's Institute of Mental Health Research, n=60, recruiting) — The goal of this clinical trial is to see if combining ketamine with behavioral activation (BA) therapy to treat moderate to severe treatment-resistant depression improves depressive symptoms and general functioning more than ketamine alone.…
Ketamine for OUD and Suicidal Ideation in the ED (Phase 2, Brigham and Women's Hospital, n=4, completed) — This is a pilot, double-blind, placebo-controlled randomized clinical trial of individuals with opioid use disorder (OUD) with suicidal ideation in the emergency department (ED) to receive either a single infusion of ketamine 0.8mg/kg (n=25) or saline placebo (n=25).…
LSD
Definium’s psychedelic prospects brighten further on Phase III success (Phase 3, Definium Therapeutics, completed) — DT120, a formulation of lysergide (LSD), demonstrated a statistically significant 5.4-point average decrease in anxiety scores (HAM-A) compared to placebo in a Phase III trial for generalized anxiety disorder (GAD). Benefits were observed as early as day two and sustained throughout the 12-week treatment period.
Big Pharma is embracing psychedelic drugs for mental health (Phase 3, AtaiBeckley, active) — AtaiBeckley's lead asset, BPL-003, a synthetic form of 5-MeO-DMT, is in Phase 3 trials for treatment-resistant depression. A Phase 2b study showed rapid and durable reductions in symptoms.
Unveiling ayahuasca: Comprehensive Study of Botanical and Chemical Diversity. (Meta-analysis) — Ayahuasca is an entheogenic beverage traditionally used by Indigenous peoples and local communities throughout Amazonia. Its preparation typically involves the vine Banisteriopsis caapi and the leaves of Psychotria viridis, widely recognized as its principal ingredients.…
Other
A Multi-Site Evaluation of a Psychedelic Medicine Curriculum for Psychiatry Trainees. (Phase 2) — Interest in psychedelic medicine is increasing, yet psychiatry trainees report limited education in this area. The authors developed a standardized curriculum and evaluated its impact on trainee knowledge and attitudes toward psychedelic medicines.…
Characterization of Altered Waking States of Consciousness in Healthy Humans (Observational, University of Zurich, n=25, completed) — Altered waking states of consciousness and its underlying functional organization have gained increasing interest in recent years, i.e. in identifying the neural basis of consciousness.…
Reflections on the Psychedelic Executive Order: The Dust Settles (News) — This article discusses an executive order related to psychedelics and its potential implications for research, therapy, and policy. It features insights from experts in the field, including discussions on psilocybin-assisted therapy and MDMA-assisted therapy for veterans.
Building Tripsafe Communities: Why We Need Psychedelic Harm Reduction (News) — This article discusses the importance of psychedelic harm reduction and introduces experts in the field, including Tomislav Majic, Maha N. Mian, and Helena Aicher, who are involved in research and clinical practice related to psychedelic substances and their risks.
FDA Holds Historic Public Hearing on Psychedelic Therapies (Regulatory, Food and Drug Administration) — The FDA convened a public hearing to discuss provider credentialing, patient safety, data standardization, and equitable access for psychedelic therapies. Stakeholders warned against over-regulation and emphasized the importance of patient choice and financially viable credentialing for providers.
Psychedelics get a hearing at FDA (News) — The FDA held a hearing on the future of psychedelics in mental healthcare, with stakeholders discussing administration and provider training for drugs like psilocybin, LSD, and MDMA.
Psychedelic drug makers rally after Trump orders FDA to expedite reviews (News) — The article discusses how psychedelic drug makers saw their stocks rally after former President Trump's administration ordered the FDA to expedite reviews of certain drugs. It does not report on specific clinical trial outcomes or statuses.