A Phase III, multicentre, randomised, double-blind, controlled study to investigate the efficacy, safety, and tolerability of two initial administrations of COMP360 in participants with treatment-resistant depression

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505268-12-00

Acronym

COMP 006

Enrollment

126

Registered

2023-10-09

Start date

2024-02-09

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment-resistant depression

Brief summary

COMP360 25 mg versus COMP360 1 mg for the change from baseline in MADRS total score at Week 6

Interventions

DRUGPsilocybin

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
COMP360 25 mg versus COMP360 1 mg for the change from baseline in MADRS total score at Week 6	—

Countries

Czechia, Denmark, France, Germany, Ireland, Netherlands, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026