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

NCT05711940 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 572

Last updated 2026-01-12

No results posted yet for this study

Summary

Efficacy, Safety, and Tolerability of two administrations of COMP360 in participants with treatment-resistant depression (TRD)

Conditions

Interventions

DRUG

Psilocybin

COMP360 Psilocybin administered under supportive conditions

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-14
Primary Completion
2026-02-28
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Ireland
  • Netherlands
  • Poland
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05711940 on ClinicalTrials.gov