Phase 2 Completed N=233 Randomized Quadruple-blind Treatment

The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression

Depression

Source: ClinicalTrials.gov NCT03775200 ↗

Enrolled (actual)

233

Serious AEs

5.1%

Results posted

Apr 2023

Primary outcomePrimary: Montgomery Asberg Depression Rating Scale (MADRS) Change From Baseline to Week 3 — -12; -8.9; -6.8 units on a scale — p=<0.05

Summary

The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression

Outcome Measures

Outcome	Result	p-value
PRIMARY Montgomery Asberg Depression Rating Scale (MADRS) Change From Baseline to Week 3	-12; -8.9; -6.8	<0.05 sig
PRIMARY MADRS Change From Baseline to Week 3, Sensitivity Analysis	-12; -8.9; -6.7	<0.05 sig

Eligibility Criteria

Inclusion Criteria

Diagnosis of TRD

Exclusion Criteria

Other comorbidities

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03775200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.