Psilocybin / Major Depression · Phase 3 Trial

Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression

ClinicalTrials.gov · August 14, 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 registry record for a Phase 3 RCT evaluating psilocybin for treatment-resistant depression in U.S. military veterans, currently recruiting. No efficacy or safety results are reported in this registry entry, so the evidence base cannot be assessed.

What was studied

Phase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Major Depression; age from 18 Years; to 75 Years. Intervention: Intervention. Compared with: Control — Active Comparator. n = 240. 5 sites: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

Clinicians should recognize this as an active, planned Phase 3 trial. No efficacy or safety conclusions can be drawn from this registry entry alone; results will be available only upon completion and publication.

Plain-language summary

This is a Phase 3 trial registration with no reported results; the study is actively recruiting and outcome data are not yet available, so evidence strength cannot be assessed.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Montgomery-Asberg Rating Scale (MADRS) (assessed at 2 weeks)

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

PopulationMajor Depression; age from 18 Years; to 75 Years

Sample size240

InterventionIntervention

ComparatorControl — Active Comparator

Setting5 sites: United States

Reported figures

Quoted from the source exactly as published.

Planned sample size240

Study phasePhase 3

Primary outcome measureMontgomery-Asberg Rating Scale (MADRS)

Primary outcome assessment timepoint2 weeks

Clinical bottom line

Caveats

This registry record reports no results; study is currently recruiting and outcomes have not been assessed.
Blinding status, allocation concealment method, and statistical analysis plan are not described in this registry entry.
Comparator arm specification is not detailed in the registry summary.
Follow-up duration beyond the primary outcome timepoint (2 weeks) is not specified.

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

Multi-site randomized controlled trial, Phase 3, appropriate for efficacy assessment.

Directness

strong

Primary outcome is MADRS, a validated clinical scale for depression severity.

Consistency

insufficient

No results reported; consistency cannot be evaluated against other trials.

Risk of bias

insufficient

Registry record does not describe blinding, allocation concealment, or trial conduct.

Sample adequacy

moderate

Planned enrollment 240 participants; adequate for Phase 3 but not yet achieved.

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 (NCT07226232). This is a study registration, not published results. Lead sponsor: VA Office of Research and Development. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 240 participants (ESTIMATED). Conditions: Major Depression. Interventions: DRUG: Psilocybin; DRUG: Psilocybin. Primary outcome measures: Montgomery-Asberg Rating Scale (MADRS) , 2 weeks. Brief summary: The purpose of this multi-site randomized controlled trial is to evaluate the efficacy and risks of psilocybin for the treatment of depression in U.S. military Veterans with and without (±) concurrent posttraumatic stress disorder.

Follow from this

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

VA Office of Research and DevelopmentNCT07226232PsilocybinMajor Depression