A Trial of GH001 in Patients With Treatment-resistant Depression

Summary

The aim of this randomized, double-blind, placebo-controlled, phase 2b clinical trial is to investigate the safety and efficacy of GH001 (containing mebufotenin \[5-methoxy-N,N-dimethyltryptamine; 5-MeO-DMT\]) in patients with treatment-resistant depression (TRD). The study is comprised of a 7-day double-blind (DB) part (Part 1) and a 6-month open-label extension (OLE) part (Part 2). Patients will be randomized to receive GH001 or placebo in a 1:1 ratio. The primary endpoint is the mean change in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to Day 7.

Timeline

Start

2023-05-24

Primary completion

2024-10-04

Completion

2025-03-11

Publications

• Cubala WJ, Bajbouj M, Bauer M, Baune BT, Cardoner N, Devlin F, Doolin K, Duenas Herrero RM, Elices M, Feeney A, Galuszko-Wegielnik M, Jakuszkowiak-Wojten K, Janu L, Kelly JR, Ledden K, Maclsaac R, Madero S, McInerney SJ, Montejo AL, Nawka A, Palenicek T, Perez Sola V, Ramaekers JG, Reif A, Ritter P, Ryan F, Svendsen CB, Sweeney C, Terwey TH, Trivedi MH, Valcheva V, Vieta E, Thase ME. GH001 vs Placebo in Patients With Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2026 Jun 1;83(6):561-569. doi: 10.1001/jamapsychiatry.2026.0096.

Drugs

Indications

No indication recorded.