Pilot RECAP Study in Healthy Volunteers (Phase 1, University of Wisconsin, Madison, n=8, completed) — The primary objective of the RECAP Study Program is to investigate the role played by conscious experience in the antidepressant effects of the psychedelic agent psilocybin.…
Psilocybin for Treatment of OCD-2 (Phase 1, Francisco A Moreno, n=20, recruiting) — Previous research indicates that psilocybin, a drug that changes activity in brain areas believed to be involved in obsessive-compulsive disorder (OCD), might improve treatment for, and improve lives of, people diagnosed with OCD.…
Effects of Psilocybin in Anorexia Nervosa (Phase 1, Johns Hopkins University, n=22, completed) — This open-label pilot study seeks to investigate the safety and efficacy of psilocybin in persons with chronic anorexia nervosa (AN). Psilocybin has previously been demonstrated to decrease depression and anxiety and increase long-term positive behavior change in other populations.…
Effects of Psilocybin in Obsessive Compulsive Disorder (Observational, Johns Hopkins University, n=35, active) — This study will test the feasibility, safety, and evidence for efficacy of psilocybin administration in participants with obsessive compulsive disorder (OCD).…
A Second Psilocybin Group Therapy for the Treatment of Cancer-Related Anxiety in Partial Responders With Metastatic Cancer (Phase 1, University of Washington, n=15, completed) — This phase I trial tests the safety and side effects of a second episode of psilocybin-assisted group therapy and how well it works in treating anxiety and distress in patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and had a partial response to their first retreat.…
VA Launches Multi-Site Psilocybin Clinical Trial (Phase 3, U.S. Department of Veterans Affairs (VA), active) — The VA launched PIVOT, a five-site clinical trial evaluating the therapeutic use of psilocybin for veterans with treatment-resistant depression. The trial investigates COMP360, a patented synthetic form of psilocybin, and aims to establish safety parameters and dosing protocols.
Compass Pathways Announces Six-Month Data from Second Phase 3 Trial Confirming Rapid and Durable Profile (Phase 3, Compass Pathways plc, n=600, active) — The second Phase 3 trial (COMP006) for COMP360 (psilocybin) in treatment-resistant depression showed that 39% of participants in the 25 mg arm achieved a clinically meaningful reduction in depression symptoms by week 6, maintaining this response through week 26. The drug demonstrated a rapid onset and durable profile with a generally well-tolerated safety profile.
COMPASS Pathways launches phase II clinical trial of psilocybin therapy in anorexia nervosa (Phase 2, COMPASS Pathways plc, n=60, recruiting) — A multi-centre, double-blind randomised controlled phase II trial will investigate the efficacy of COMP360 psilocybin therapy in anorexia nervosa. The trial will compare 25 mg and 1 mg of COMP360 psilocybin in 60 participants, with the primary endpoint being the change from baseline in the EDE global score at week 4.
Study finds sustained benefit for people using Oregon psilocybin services (Observational, Oregon Health & Science University) — Participants in a study of Oregon psilocybin services reported relief from symptoms of anxiety, depression, and PTSD, with almost two-thirds declaring the experience to be among the most meaningful of their life. Safety was similar to clinical settings, with few adverse events reported.
Psilocybin users report real-world outcomes in new study (Observational) — A study published in the Journal of Psychopharmacology found that individuals who used psilocybin for mental health purposes reported positive outcomes, including reduced symptoms of depression and anxiety, and improved overall well-being. The study surveyed 1,169 psilocybin users, with the majority reporting significant benefits.
More than 20,000 people have used legal psilocybin in Oregon. A new study shows how it went (Observational, OHSU, n=350) — A study of 350 volunteers in Oregon's legal psilocybin program found that a majority reported fewer symptoms of anxiety and depression, and serious negative mental health impacts occurred in only about 1% of participants. The program's safety was assessed as comparable to clinical trials despite a less controlled environment.
[(Es)ketamine: practice update]. (Phase 2) — Ketamine has been established as an anesthetic agent for decades. Around the turn of the millennium initial clinical studies demonstrated that subanesthetic doses of ketamine can exert antidepressant effects in treatment-resistant depression.…
A Study of Esketamine Nasal Spray Versus Placebo Spray in Adult Participants With Treatment-resistant Depression (Phase 3, Janssen Research & Development, LLC, n=348, recruiting) — The purpose of this study is to evaluate how well each individual dose of esketamine (56 milligrams \[mg\] and 84 mg) works when compared with placebo in improving depressive symptoms in participants with treatment resistant depression (individuals with major depressive disorder \[MDD\] who have not responded to at least 2 different antidepressant treatments given at an adequate dose for an adequate duration in the current episode of depression).
The Effect of Ketamine on Aesthetics and Role for Antidepressant Effects (Phase 1, Medical University of Vienna, n=60, active) — The aim of this study is to assess the impact of ketamine on aesthetic perception and processing. This study assesses the role of these effects in facilitating ketamine's antidepressant properties, with a focus on anhedonia.…
Ketamine in the Treatment of Depression (Phase 2, Columbia University, n=38, completed) — Depressed patients will be offered experimental treatment with a new, potentially fast-acting antidepressant called ketamine while being scanned by magnetic resonance imaging (MRI) to measure the chemical effect of the drug.…
Treatment Resistant Depression (Pilot) (Observational, Washington University School of Medicine, n=20, completed) — Treatment resistant depression (TRD) is a major public health problem. Current therapeutic options for this patient population remain limited. With all available treatments, only a sub-set of those patients who achieve an antidepressant response are likely to achieve treatment-induced remission.…
Chart Review of Patients Undergoing Ketamine Treatments for Depression (Observational, Sunnybrook Health Sciences Centre, n=250, completed) — The Ontario Ketamine and Infusion Centre (OKIC) is a CPSO-certified Level-II OHP and an outpatient centre for intravenous ketamine treatments for treatment-resistant depression.…
Ketamine & Crisis Response Plan for Suicidal Ideation in the ED (Phase 2, The University of Texas Health Science Center at San Antonio, n=24, recruiting) — The goal of this randomized pilot trial is to assess the feasibility of administering a combination of 100mg intramuscular (IM) ketamine and Crisis Response Plan (a short psychosocial intervention) for patients with acute suicidality in the context of the Emergency Department setting.…
Ketamine As an Adjunctive Therapy for Major Depression (2) (Phase 3, University of Dublin, Trinity College, n=63, completed) — Pragmatic, randomised, controlled, parallel-group, superiority trial of ketamine vs. midazolam as an adjunctive therapy for depression.…
Ketamine Assisted Psychotherapy for Treating Comorbid Chronic Pain and PTSD (Phase 1, Queen's University, n=30, recruiting) — The goal of this pilot study is to evaluate the feasibility of conducting a clinical trial assessing if ketamine infusions combined to mindfulness therapy works better than psychotherapy alone to treat chronic pain and PTSD in adults living with both conditions.…
Subanesthetic Esketamine in Modified ECT for Severe Depression in Adolescents: Clinical and Mechanistic Study (Observational, Min Su, n=220, recruiting) — The study design was a randomized, double blind, parallel controlled trial.The goal of this clinical trial is to learn if esketamine-assisted modified electroconvulsive therapy (ESK-MECT) works to treat severe depression in adolescents. It will also learn about the safety of ESK-MECT.…
Ketamine and Scopolamine Infusions for Treatment-resistant Major Depressive Disorder (Observational, Massachusetts General Hospital, completed) — Ketamine infusions resulted in an acute reduction in global depression scores and in severity of suicidal ideation. Scopolamine infusions produced also a significant improvement in depression that was sustained over time.…
Ketamine in Borderline Personality Disorder (Phase 2, Yale University, n=22, completed) — The purpose of this study is to test the potential of the rapid-acting anti-depressant ketamine to decrease suicidality in Borderline Personality Disorder (BPD). The rate of completed suicide in BPD is similar to that of depression or schizophrenia.…
Ketamine: How Yale Redefined Depression Treatment (News, Yale School of Medicine) — In 2000, Yale researchers reported that ketamine could rapidly alleviate symptoms of major depression, often within hours, marking a significant advance in treatment and opening new research avenues. Ketamine targets the brain's glutamate system, stimulating the production of new synapses between brain cells, which contrasts with traditional antidepressants that act on serotonin pathways and take weeks to show effect.
Long Term Follow Up Study to COMP 001 And COMP 003 Trials (P-TRD LTFU) (Observational, COMPASS Pathways, n=66, completed) — The primary objective of this study is to assess the long-term efficacy of psilocybin with respect to use of new antidepressant treatment, hospitalisations for depression, suicidality, and depressive severity rated using the Montgomery and Asberg Depression Rating Scale (MADRS) over a total of 52 weeks (compared across the 1 mg, 10 mg and 25 mg psilocybin groups from COMP 001).
AOC, Other Members of Congress Tout Psychedelic Benefits as Research Amendments Advance (News, Department of Defense) — Bipartisan lawmakers are leveraging the National Defense Authorization Act to extend military clinical trials for substances like psilocybin and MDMA. The Department of Veterans Affairs is also pushing to expedite treatment research for PTSD. A Louisiana law uses opioid settlement funds for a pilot program targeting substance abuse and treatment-resistant mental health conditions.
How Trump is pushing psychedelics reform through the health agencies (News) — An executive order signed by President Trump aims to accelerate research into psychedelic treatments for mental health conditions, particularly PTSD. The order directs federal agencies to identify and remove barriers to research and clinical trials.
U.S. FDA moves to fast-track psychedelic drugs after Trump order (Regulatory, U.S. FDA) — The U.S. Food and Drug Administration (FDA) is moving to fast-track the development of psychedelic drugs for medical use, following an executive order from former President Donald Trump. This initiative aims to accelerate the review process for these novel therapies.