NCT05800860 is a Phase 2 clinical trial of GH001 in Treatment-resistant Depression, sponsored by GH Research Ireland Limited.

Who is sponsoring NCT05800860?

NCT05800860 is sponsored by GH Research Ireland Limited.

What drugs are being tested in NCT05800860?

Interventions in NCT05800860: GH001, Placebo.

What condition does NCT05800860 study?

NCT05800860 studies Treatment-resistant Depression.

Is NCT05800860 still recruiting?

NCT05800860 is currently completed. Last updated 31 May 2025.

Last reviewed 2025-05-31 · How we verify

NCT05800860

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Trial of GH001 in Patients With Treatment-resistant Depression

Completed Phase 2 Last updated 31 May 2025

What this trial tests

Phase 2 trial testing GH001 in Treatment-resistant Depression in 81 participants. Completed in 11 March 2025.

Timeline

24 May 2023

Primary endpoint
4 October 2024

11 March 2025

Quick facts

Lead sponsor	GH Research Ireland Limited
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	81
Start date	24 May 2023
Primary completion	4 October 2024
Estimated completion	11 March 2025
Sites	11 locations across Netherlands, Ireland, Germany, Poland, Spain, Czechia

Drugs / interventions tested

GH001 — full drug profile →
Placebo

Conditions studied

Treatment-resistant Depression — all drugs for Treatment-resistant Depression →

Sponsor

GH Research Ireland Limited — full company profile →

Who can join

Adults 18 to 64, any sex, with Treatment-resistant Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Emerging Medications for Treatment-Resistant Depression: A Review with Perspective on Mechanisms and Challenges.
Lucido MJ, Dunlop BW. · · 2025 · cited 7× · PMID 40002494 · DOI 10.3390/brainsci15020161
Pharmacological Monotherapy for Depressive Disorders: Current and Future-A Narrative Review.
Gao K, Oruc EB, Koparal B. · · 2025 · cited 3× · PMID 40282849 · DOI 10.3390/medicina61040558
Ayahuasca and Its Main Component <i>N,N</i>-Dimethyltryptamine (DMT) for the Treatment of Mental Disorders: Mechanisms of Action, Clinical Studies, and Tools to Explore the Human Mind.
Melani A, Papini G, Bonaso M, Biso L, et al · · 2026 · PMID 41898153 · DOI 10.3390/biomedicines14030506
GH001 vs Placebo in Patients With Treatment-Resistant Depression: A Randomized Clinical Trial.
Cubala WJ, Bajbouj M, Bauer M, Baune BT, et al · · 2026 · PMID 41879760 · DOI 10.1001/jamapsychiatry.2026.0096
Molecular, haemodynamic and functional effects of LSD in the human brain
McCulloch DE, Larsen K, Johansen A, Reveles Jensen KH, et al · · 2025 · DOI 10.1101/2025.06.17.25329677

Verify or expand the search:

Other trials of GH001

Trials testing the same drug.

NCT05839509 — Phase 2 Clinical Trial of GH001 in Bipolar II Disorder · Phase 2 · terminated
NCT05804708 — Phase 2 Clinical Trial of GH001 in Postpartum Depression · Phase 2 · terminated

Other recruiting trials for Treatment-resistant Depression

Currently open trials in the same condition.

NCT05661383 — Olfactory and Brain Stimulations in Treatment-resistant Depression · NA · recruiting
NCT05607654 — The Mechanisms of Underlying Accelerated Repetitive Transcranial Magnetic Stimulation for Treatment-resistant Depression · NA · recruiting
NCT05377177 — Cortical Inhibition as a Biomarker of Response in a Comparison of Bilateral Versus Unilateral Accelerated Theta Burst St · NA · recruiting
NCT04680910 — Slow Wave Induction by Propofol to Eliminate Depression (SWIPED) I · Phase 1 · active not recruiting

Other GH Research Ireland Limited trials

Trials by the same sponsor.

NCT05839509 — Phase 2 Clinical Trial of GH001 in Bipolar II Disorder · Phase 2 · terminated
NCT05804708 — Phase 2 Clinical Trial of GH001 in Postpartum Depression · Phase 2 · terminated
NCT05753956 — Safety and Pharmacokinetics of GH002 in Healthy Volunteers · Phase 1 · completed
NCT05163691 — Pharmacokinetics of GH001 in Healthy Volunteers · Phase 1 · completed
NCT04698603 — Clinical Study of GH001 in Depression · Phase 1, PHASE2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05800860 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GH Research Ireland Limited
Last refreshed: 31 May 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05800860.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing