A randomized, double-blind, placebo-controlled, Phase 2b trial with an open-label extension to determine the safety and efficacy of GH001 in patients with treatment-resistant depression.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-510047-37-00

Acronym

GH001-TRD-201

Enrollment

Registered

2024-10-25

Start date

2023-03-30

Completion date

2025-03-11

Last updated

2024-11-08

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

Conditions

Treatment-resistant depression (TRD)

Brief summary

Mean change in MADRS from Baseline to Day 7

Interventions

DRUGMebufotenin

DRUGInhalation vapour

DRUGliquid

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Mean change in MADRS from Baseline to Day 7	—

Countries

Czechia, Germany, Ireland, Poland, Spain

Outcome results

None listed

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