Clinical trials: Psilocybin, active
Bipolar II Depression
Psilocybin-Assisted Therapy for Treatment-Resistant Depression in Bipolar II Disorder
This study is a 12-week (in addition to up to 30 days of screening) randomized, double-blind, placebo-controlled, parallel-group trial.
- Trial name
- PAT-BD-01 (NCT06943573)
- Testing
- psilocybin (25 mg), psilocybin 1mg micro-dose
- Where
- 3 sites in Canada
- Volunteers
- 90 people
- Sponsor
- Lakshmi N Yatham
Obsessive-compulsive Disorder
Evaluating the Feasibility, Safety and Efficacy of Psychotherapy Assisted Psilocybin for Treatment of Severe OCD
Obsessive-compulsive disorder (OCD) is a neuropsychiatric disorder characterized by recurrent distressing thoughts and substantial anxiety, accompanied by repetitive behaviors or mental rituals.
- Trial name
- NCT04882839
- Testing
- psychotherapy assisted psilocybin
- Where
- Israel
- Volunteers
- 15 people
- Sponsor
- Beersheva Mental Health Center
Alzheimer's Disease
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Background: Normal aging, as well as dementias such as Alzheimer s disease, can cause changes in the brain that affect memory, attention, and thinking.
- Trial name
- NCT07721467
- Testing
- Psilocybin, Cognitive Training
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- National Institute on Aging (NIA)
Spinal Cord Injury, Depression - Major Depressive Disorder
Psilocybin to Treat Depression in Spinal Cord Injury
The main goal of this study is to determine if psilocybin is safe for use in people with SCI. The study will measure how people with SCI respond to three psilocybin doses: low (5mg), medium (10mg), and high (25mg).
- Conditions
- Spinal Cord Injury, Depression - Major Depressive Disorder, Veteran
- Trial name
- STOP (NCT07251491)
- Testing
- Psilocybin (Usona Institute)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- James J. Peters Veterans Affairs Medical Center
Major Depressive Disorder (MDD), Depression in Adults
A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD.
- Conditions
- Major Depressive Disorder (MDD), Depression in Adults, Depression - Major Depressive Disorder, Depression Disorders
- Trial name
- EMBRACE (NCT06793397)
- Testing
- CYB003, Psychological Support
- Where
- 79 sites in United States, Australia and 6 more
- Volunteers
- 330 people
- Sponsor
- Cybin IRL Limited
PTSD
Safety and Preliminary Efficacy of Organic Whole Psilocybin-Containing Mushrooms to Treat Patients Suffering From PTSD
This study will examine the safety and preliminary efficacy of psilocybin mushrooms to treat adults with PTSD. Up to 24 participants will take part in this study.
- Trial name
- PASSAGE (NCT07275970)
- Testing
- Psychedelic
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Scottsdale Research Institute
Major Depressive Disorder, Alcohol Use Disorder
Psilocybin Treatment of Major Depressive Disorder With Co-occurring Alcohol Use Disorder
The purpose of this study is to determine whether psilocybin, a hallucinogenic drug, is effective in reducing depressive symptoms and amount of drinking in patients with co-occurring Major Depressive Disorder (MDD) and Alcohol…
- Trial name
- PsiloMDDAUD (NCT04620759)
- Testing
- Psilocybin
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Johns Hopkins University
Psychedelic Microdosing Effects on Mood, Cognition, Subjective Well-being and MRI
Psilocybin Microdosing on Cognition, Mood and Quality of Life
This study is being conducted to evaluate how of 30 days of intermittently microdosed psilocybin affects mood, cognition, subjective well-being and structural/functional MRI results compared to a placebo.
- Trial name
- NCT07449351
- Testing
- Psliocybin
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Yale University
Depression - Major Depressive Disorder, Psilocybin
Group PACBT for Depression
This study will seek to determine the (1) acceptability and (2) feasibility of psilocybin as an adjunct to cognitive-behavioral therapy, delivered as a group treatment (G-PACBT) for major depressive disorder and (3) explore the…
- Conditions
- Depression - Major Depressive Disorder, Psilocybin, Cognitive Behavioral Therapy
- Trial name
- NCT07566104
- Testing
- Psilocybin (drug), Group Cognitive Behavioral Therapy
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of California, Los Angeles
Major Depressive Disorder
A Phase II, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of COMP360 in Participants With Recurrent Major Depressive Disorder
Safety, Tolerability, pharmacokinetics and efficacy of a single administration of COMP360 in participants with recurrent Major Depressive Disorder.
- Trial name
- NCT05733546
- Testing
- Psilocybin
- Where
- 5 sites in United States
- Volunteers
- 102 people
- Sponsor
- COMPASS Pathways
Major Depressive Disorder (MDD)
Salivary Oxytocin as a Biomarker of Psychedelic Treatment
This study aims to investigate whether oxytocin reactivity during a psychedelic session for MDD treatment predicts treatment response, specifically by examining its relationship with changes in flexibility and depressive symptoms.
- Trial name
- PAPOXT_MDD (NCT07345858)
- Where
- Switzerland
- Volunteers
- 80 people
- Sponsor
- University of Geneva, Switzerland
Alcohol Use Disorder (AUD), PTSD
PsiloStudy: Psilocybin With Psychological Support (Psi-PS) for Military Veterans and First Responders With Co-occurring PTSD & Alcohol Use Disorder (AUD)
This study is a phase 2 single-site, double-blind, placebo-controlled, randomized clinical trial with an open-label extension phase to examine the safety of psilocybin (25 mg) combined with psychological support (Psi-PS) for…
- Trial name
- Psi-PS (NCT06853912)
- Testing
- Psilocybin 25 mg
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Nathan Brashares Sackett
Depressive Disorder
Psilocybe Cubensis Mushrooms With or Without Fluoxetine for Refractory Depression
This Phase 2a pilot, exploratory, randomized, double-blind, placebo-controlled, parallel-group trial will estimate whether concurrent fluoxetine alters the antidepressant effect, acute psychedelic experience, or safety of a…
- Trial name
- COGUNILA (NCT06898606)
- Testing
- Psilocybin and Psilocyn, Psychotherapy-assisted session, Fluoxetine
- Where
- Brazil
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Federal University of Latin American Integration
Amblyopia
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
The purpose of this study is to evaluate whether ingestion of a drug called psilocybin can increase the effectiveness of amblyopia therapy in adults with amblyopia.
- Trial name
- PATCH (NCT07920081)
- Testing
- Amblyopia Therapy, 1 mg Psilocybin, 5 mg Psilocybin
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Johns Hopkins University
Treatment-resistant Depression (TRD)
Psilocybin-Assisted Group Integration Psychotherapy for Treatment-Resistant Depression
Psilocybin-assisted psychotherapy requires a lot of resources, with more psychotherapy being provided to integrate the meanings and insights derived from the psilocybin dosing sessions.
- Trial name
- PSI-GROUP (NCT07737990)
- Testing
- Group integration therapy
- Where
- Canada
- Volunteers
- 65 people
- Sponsor
- Joshua Rosenblat
Amphetamine-Related Disorders
Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder
This is a proof-of-concept randomized clinical trial of psilocybin-enhanced psychotherapy versus treatment-as-usual among individuals being treated for methamphetamine use disorder.
- Trial name
- NCT04982796
- Testing
- Psilocybin, Treatment-as-usual
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Portland VA Research Foundation, Inc
Alcohol Use Disorder
Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD
This is a double-blind, randomized, placebo-controlled Phase 2 mechanistic clinical trial designed to evaluate the therapeutic neural mechanisms of psilocybin in patients with alcohol use disorder (AUD), and to determine whether…
- Trial name
- NCT06349083
- Testing
- Psilocybin, Supportive therapy sessions
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- NYU Langone Health
Treatment Resistant Depression, Autism Spectrum Disorder
Psilocybin for Treatment-Resistant Depression in Autism
We propose a first-of-its-kind open-label clinical trial to investigate the feasibility, tolerability, and safety of administering psilocybin in autistic adults with treatment-resistant depression (TRD).
- Trial name
- PAT-DA (NCT06731621)
- Testing
- Psilocybin
- Where
- Canada
- Volunteers
- 18 people
- Sponsor
- Centre for Addiction and Mental Health
Treatment-Resistant Depression
Evaluating the Role of Psilocybin Monitors in Psilocybin Therapy for Treatment Resistant Depression
Psilocybin, the chemical component of "magic mushrooms", has been administered with psychological support in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects.
- Trial name
- PSI-TNT (NCT07211438)
- Testing
- Psilocybin
- Where
- 2 sites in Canada
- Volunteers
- 40 people
- Sponsor
- Centre for Addiction and Mental Health
Treatment Resistant Depression
Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD
Efficacy, Safety, and Tolerability of two administrations of COMP360 in participants with treatment-resistant depression (TRD)
- Trial name
- NCT05711940
- Testing
- Psilocybin
- Where
- 116 sites in United States, Canada and 10 more
- Volunteers
- 572 people
- Sponsor
- COMPASS Pathways