9 completed, 2 active not recruiting, 2 recruiting, 2 unknown. 12 Phase 2, 4 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 12 | Completed 7, Unknown 2, Active not recruiting 1, Recruiting 1, Withdrawn 1 |
| Phase 3 | 4 | Recruiting 2, Active not recruiting 1, Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder COMP360 psilocybin - PTSD - Post Traumatic Stress Disorder, PTSD | Phase 2 / Phase 3 | Recruiting | COMPASS Pathways | 300 | 2026-09-01 | 2026-10-23 |
| The Effects of Psilocybin on Self-Focus and Self-Related Processing in Major Depressive Disorder Psilocybin - Major Depressive Disorder | Phase 3 | Recruiting | Sharmin Ghaznavi | 20 | 2024-09-10 | 2026-08-13 |
| Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD Psilocybin - Treatment Resistant Depression | Phase 3 | Active not recruiting | COMPASS Pathways | 572 | 2023-02-14 | 2026-08-10 |
| 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 Psilocybin - Major Depressive Disorder | Phase 2 | Active not recruiting | COMPASS Pathways | 102 | 2023-01-30 | 2025-08-19 |
| Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD Psilocybin - Treatment Resistant Depression | Phase 3 | Completed | COMPASS Pathways | 258 | 2023-01-24 | 2026-08-10 |
| Efficacy and Safety of COMP360 Psilocybin Therapy in Anorexia Nervosa: a Proof-of-concept Study Psilocybin - Anorexia Nervosa | Phase 2 | Completed | COMPASS Pathways | 32 | 2022-10-12 | 2024-12-04 |
| The Effects of Psilocybin on Self-Focus and Self-Related Processing in Treatment Resistant MDD Psilocybin - Treatment-Resistant Major Depressive Disorder | Phase 2 | Withdrawn | Massachusetts General Hospital | 2022-09-15 | 2024-01-24 | |
| The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder Psilocybin - Post Traumatic Stress Disorder | Phase 2 | Completed | COMPASS Pathways | 22 | 2022-06-10 | 2025-06-13 |
| The Safety and Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic Suicidal Ideation Psilocybin - Treatment Resistant Depression, Suicidal Ideation | Phase 2 | Completed | Sheppard Pratt Health System | 20 | 2022-03-28 | 2025-12-24 |
| Evaluation of Psilocybin in Anorexia Nervosa: Safety and Efficacy Psilocybin - Anorexia Nervosa | Phase 2 | Completed | University of California, San Diego | 16 | 2021-05-01 | 2022-07-25 |
| An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD) Psilocybin - Treatment Resistant Depression | Phase 2 | Unknown | Sheppard Pratt Health System | 27 | 2021-03-01 | 2024-08-09 |
| The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression. Psilocybin - Treatment Resistant Depression | Phase 2 | Unknown | Sheppard Pratt Health System | 15 | 2021-03-01 | 2022-10-25 |
| Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder Psilocybin - Body Dysmorphic Disorders | Phase 2 | Completed | New York State Psychiatric Institute | 12 | 2021-02-26 | 2023-03-13 |
| The Safety and Efficacy Of Psilocybin as an Adjunctive Therapy in Participants With Treatment Resistant Depression Psilocybin - Treatment Resistant Depression | Phase 2 | Completed | COMPASS Pathways | 19 | 2020-08-10 | 2023-11-09 |
| Long Term Follow Up Study to COMP 001 And COMP 003 Trials (P-TRD LTFU) Treatment Resistant Depression | Completed | COMPASS Pathways | 66 | 2020-07-20 | 2022-09-22 | |
| The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression Psilocybin - Treatment Resistant Depression | Phase 2 | Completed | COMPASS Pathways | 233 | 2019-03-01 | 2023-04-24 |
Depressive Disorder, Treatment-Resistant (9) · Depressive Disorder, Major (3) · Anorexia Nervosa (2) · Stress Disorders, Post-Traumatic (2) · Anorexia (1) · Body Dysmorphic Disorders (1) · Combat Disorders (1) · Feeding and Eating Disorders (1) · Mental Disorders (1) · Rumination Syndrome (1) · Suicidal Ideation (1) · Wounds and Injuries (1)
Psilocybin (14)
United States (16) · Ireland (5) · United Kingdom (5) · Canada (3) · Czechia (3) · Netherlands (3) · Denmark (2) · Germany (2) · Spain (2) · France (1) · Poland (1) · Portugal (1) · Sweden (1)
Scott Aaronson, MD (3) · Franklin Schneier, MD (1) · Guy Goodwin (1) · Sharmin Ghaznavi, M.D., Ph.D. (1) · Sharmin Ghaznavi, MD, PhD (1)
PMID 31543078, PMID 36322843, PMID 37488291, PMID 38055270, PMID 38988455, PMID 39343309, PMID 39741440, PMID 40047545, PMID 40375477, PMID 40458078, PMID 40499827, PMID 40883964, PMID 41362124, PMID 41497513, PMID 41881122, PMID 42138588, PMID 42248535, PMID 42460632