Treatment Resistant Depression / Psilocybin · Phase 3 Trial

Efficacy, Safety, and Tolerability of COMP360 in Participants With TRD

ClinicalTrials.gov · August 10, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a completed Phase 3 registry record for COMP360 (psilocybin) in treatment-resistant depression. No results are posted in this registry entry, so efficacy, safety, or tolerability cannot be assessed from this source alone.

What was studied

Phase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Treatment Resistant Depression; age from 18 Years. Intervention: 25 mg COMP360 Psilocybin. Compared with: Placebo — Placebo Comparator. n = 258. 40 sites: United States.

Key findings

Safety

Results are not posted in this registry record; no efficacy, safety, or tolerability data are available

Who this may help

Clinicians and researchers should await publication of the completed trial results to evaluate whether single-dose psilocybin offers efficacy and an acceptable safety profile in TRD. This registry entry alone provides no evidence for clinical decision-making.

Plain-language summary

This is a completed Phase 3 registry record with no results posted; the study is planned but outcomes are not yet reported in this source.

Study design

As stated by the source record.

MethodsPrimary outcome measure: COMP360 25 mg versus placebo for the change from baseline in MADRS total score (assessed at Week 6)

DesignPhase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose

PopulationTreatment Resistant Depression; age from 18 Years

Sample size258

Intervention25 mg COMP360 Psilocybin

ComparatorPlacebo — Placebo Comparator

Setting40 sites: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment258

Primary outcome measureChange from baseline in MADRS total score at Week 6

Study phasePHASE3

Study typeINTERVENTIONAL

Clinical bottom line

Caveats

Results are not posted in this registry record; no efficacy, safety, or tolerability data are available
Randomization method, blinding status, and allocation concealment not disclosed
Study setting, specific eligibility criteria, and dosing regimen details not provided in registry abstract
No effect sizes, p-values, or confidence intervals reported

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Phase 3 interventional design comparing active drug to placebo

Directness

strong

Primary outcome directly measures depression severity (MADRS) at Week 6

Consistency

insufficient

No results reported; cannot assess consistency with prior work

Risk of bias

insufficient

Registry record does not disclose randomization, blinding, or allocation concealment methods

Sample adequacy

moderate

258 participants enrolled for Phase 3; adequacy depends on effect size assumptions not stated

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05624268). This is a study registration, not published results. Lead sponsor: COMPASS Pathways. Recruitment status: COMPLETED. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 258 participants (ACTUAL). Conditions: Treatment Resistant Depression. Interventions: DRUG: Psilocybin. Primary outcome measures: COMP360 25 mg versus placebo for the change from baseline in MADRS total score , Week 6. Brief summary: Efficacy, Safety, and Tolerability of a single administration of COMP360 in participants with treatment-resistant depression (TRD)

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Treatment Resistant DepressionNCT05624268COMPASS PathwaysPsilocybin