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Phase 3 development landscape

Phase 3 Psilocybin Clinical Trials

Review psilocybin studies registered as Phase 3, with current recruitment status, indications, enrollment, sponsors, locations, and direct registry provenance.

Registry status is not a guarantee of local availability, eligibility, safety, or efficacy. Confirm every participation decision in the authoritative ClinicalTrials.gov record.

13matching trials
5currently recruiting
198registry-listed sites

Registry facts checkedAug 10, 2026 01:26 UTC

Live registry synthesis

Status, geography, and study phase

This page preserves the phase assigned in ClinicalTrials.gov. Trial phase is a design and development attribute, not a claim that an intervention is approved, effective, or appropriate for an individual.

Recruitment status

  1. Recruiting5
  2. Active, not recruiting4
  3. Not yet recruiting3
  4. Completed1

Leading countries

  1. United States8
  2. Canada3
  3. France2
  4. Pakistan1
  5. Czechia1
  6. Denmark1
  7. Germany1
  8. Ireland1

Trial phases

  1. Phase 313
  2. Phase 22
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13 matching registry records

Every factual summary is crawlable without JavaScript. Use the direct registry link for current eligibility, contacts, and site availability.

Active, not recruitingNCT06308653

A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Psilocybin in Adults With Major Depressive Disorder (MDD)

Usona Institute

Conditions
Depressive Disorder, Major
Phase
Phase 3
Enrollment
238 actual
Locations
University of Alabama Clinical Research Unit, Birmingham, Alabama, United States · Preferred Research Partners-NWA, LLC, Fayetteville, Arkansas, United States · Preferred Research Partners, Inc., Little Rock, Arkansas, United States · +26 more
Registry updated
2026-07-23
RecruitingNCT06247839

The Effects of Psilocybin on Self-Focus and Self-Related Processing in Major Depressive Disorder

Sharmin Ghaznavi

Conditions
Major Depressive Disorder
Phase
Phase 3
Enrollment
20 estimated
Locations
Athinoula A. Martinos Center for Biomedical Imaging, Charlestown, Massachusetts, United States
Registry updated
2026-07-17
RecruitingNCT07703722

Effect of Psilocybin and Structured Integrated Reframing Therapy on Gut-Brain Axis Biomarkers and Depression in Trauma-Related Major Depressive Disorder: Randomized Controlled Trial

Khyber Medical University Peshawar

Conditions
Major Depressive Disorder · Post-Traumatic Stress Disorder (PTSD)
Phase
Phase 3
Enrollment
60 estimated
Locations
Institute of Health Science, Khyber Medical University, Islamabad, Capital, Pakistan · Hayatabad Medical Complex Peshawar, Peshawar, KPK, Pakistan · Khyber Medical University, Peshawar, KPK, Pakistan
Registry updated
2026-07-14
RecruitingNCT07063862

PSilocybin Microdose for psYCHological and Existential Distress in PALliative Care (PSYCHED-PAL): A Multi-site Phase 3 Double-blind, Placebo-controlled, Parallel-arm Clinical Trial

Bruyère Health Research Institute.

Conditions
Psychological Distress
Phase
Phase 3
Enrollment
120 estimated
Locations
William Osler Health System, Brampton, Ontario, Canada · Providence Care Hospital, Kingston, Ontario, Canada · St. Joseph's Healthcare, London, Ontario, Canada · +4 more
Registry updated
2026-07-10
RecruitingNCT07638553

Efficacy in Relapse Prevention: Psilocybin in Alcohol Use Disorder With Depressive Symptoms

Centre Hospitalier Universitaire de Nīmes

Conditions
Alcohol Use Disorder · Depressive Sympotoms · Psilocybin
Phase
Phase 3
Enrollment
172 estimated
Locations
Centre Hospitalier de la Côte Basque, Bayonne, France · CHU Besançon, Besançon, France · CHU de Bordeaux, Bordeaux, France · +5 more
Registry updated
2026-07-01
Not yet recruitingNCT07226232

A Multi-site Randomized Controlled Trial of Psilocybin for Treatment-Resistant Depression (TRD) in Veterans

VA Office of Research and Development

Conditions
Major Depression
Phase
Phase 3
Enrollment
240 estimated
Locations
Birmingham VA Medical Center, Birmingham, AL, Birmingham, Alabama, United States · Tuscaloosa VA Medical Center, Tuscaloosa, AL, Tuscaloosa, Alabama, United States · VA Portland Health Care System, Portland, OR, Portland, Oregon, United States · +2 more
Registry updated
2026-06-05
Not yet recruitingNCT07570654

A Phase 2b/3, Multicentre, Randomised, Double-blind, Controlled Trial, With an Open Label Extension, to Investigate the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder

COMPASS Pathways

Conditions
PTSD - Post Traumatic Stress Disorder · PTSD · PTSD Symptoms · PTSD, Post Traumatic Stress Disorder
Phase
Phase 2 · Phase 3
Enrollment
300 estimated
Locations
No mapped site reported
Registry updated
2026-05-12
Active, not recruitingNCT06303739

Induction Protocol for Psilocybin-Assisted Therapy in Treatment-Resistant Depression (TRD): A Pilot Study

University of North Carolina, Chapel Hill

Conditions
Refractory Depression · Treatment Resistant Depression
Phase
Phase 3
Enrollment
20 actual
Locations
UNC Chapel Hill Medical Center, Chapel Hill, North Carolina, United States
Registry updated
2026-05-06
Not yet recruitingNCT06943573

Psilocybin-Assisted Therapy for Treatment-Resistant Depression in Bipolar II Disorder: A Randomized Controlled Trial

Lakshmi N Yatham

Conditions
Bipolar II Depression
Phase
Phase 3
Enrollment
90 estimated
Locations
Djavad Mowafaghian Centre for Brain Health, Vancouver, British Columbia, Canada · Department of Psychiatry, University of Ottawa, The Ottawa Hospital, Ottawa, Ontario, Canada · Department of Psychiatry, University of Toronto, University Health Network,, Toronto, Ontario, Canada
Registry updated
2026-05-01
Active, not recruitingNCT05711940

A Phase III, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With Treatment-resistant Depression

COMPASS Pathways

Conditions
Treatment Resistant Depression
Phase
Phase 3
Enrollment
572 actual
Locations
Lighthouse Psychiatry Scottsdale, Gilbert, Arizona, United States · Clinical Innovations, Inc., Bellflower, California, United States · M3 Wake Research, Encino, California, United States · +113 more
Registry updated
2026-01-12
Active, not recruitingNCT05624268

A Phase III, Multicentre, Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety, and Tolerability of COMP360 in Participants With Treatment-resistant Depression

COMPASS Pathways

Conditions
Treatment Resistant Depression
Phase
Phase 3
Enrollment
255 estimated
Locations
University of Arizona College of Medicine - Tuscon, Tucson, Arizona, United States · ProScience Research Group, Culver City, California, United States · Collaborative Neuroscience Network, LLC, Garden Grove, California, United States · +37 more
Registry updated
2025-12-18
RecruitingNCT05398484

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Effects of Psilocybin-assisted Psychotherapy on Psychiatric and Existential Distress in Advanced Cancer

NYU Langone Health

Conditions
Advanced Cancer
Phase
Phase 2 · Phase 3
Enrollment
200 estimated
Locations
University of Colorado Anschutz Medical campus (CU AMC), Aurora, Colorado, United States · NYU Langone Health, New York, New York, United States
Registry updated
2025-12-04
CompletedNCT05163496

A Randomized, Placebo-controlled Trial of Psychedelic-assisted Psychotherapy With Single Dose Psilocybin for Frontline Clinicians Experiencing COVID-related Symptoms of Depression and Burnout

University of Washington

Conditions
Burnout, Caregiver · Burnout, Professional · COVID-19 · Depression
Phase
Phase 3
Enrollment
30 actual
Locations
University of Washington, Seattle, Washington, United States
Registry updated
2025-03-18
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