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NCT05839509
Phase 2 Clinical Trial of GH001 in Bipolar II Disorder
Phase 2 trial testing GH001 in Bipolar II Disorder in 6 participants. Terminated before completion.
13 November 2024
Quick facts
| Lead sponsor | GH Research Ireland Limited |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 6 |
| Start date | 6 April 2023 |
| Primary completion | 13 November 2024 |
| Estimated completion | 5 December 2024 |
| Sites | 7 locations across United Kingdom, Netherlands, Germany |
Drugs / interventions tested
- GH001 — full drug profile →
Conditions studied
- Bipolar II Disorder — all drugs for Bipolar II Disorder →
Sponsor
GH Research Ireland Limited — full company profile →
Who can join
Adults 18 to 64, any sex, with Bipolar II Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a multicenter, open-label, single-arm Phase 2 clinical trial. Approximately 15 participants with clinically diagnosed bipolar disorder (BD) type II and experiencing a current episode of depression will be included in this study. The participants will receive an individualized dosing regimen (IDR) with at least one and up to three doses of GH001 administered within a single day.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
The possible place for psychedelics in pharmacotherapy of mental disorders.
Wojtas A. · · 2023 · cited 7× · PMID 37934320 · DOI 10.1007/s43440-023-00550-9 -
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:
- PubMed search for NCT05839509
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of GH001
Trials testing the same drug.
- NCT05800860 — A Trial of GH001 in Patients With Treatment-resistant Depression · Phase 2 · completed
- NCT05804708 — Phase 2 Clinical Trial of GH001 in Postpartum Depression · Phase 2 · terminated
Other recruiting trials for Bipolar II Disorder
Currently open trials in the same condition.
- NCT07213466 — Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder · Phase 4 · recruiting
- NCT07127913 — Closed-Loop Deep Brain Stimulation for Treatment-Resistant Bipolar Depression · NA · recruiting
- NCT06184581 — Lithium Versus Lamotrigine in Bipolar Disorder, Type II · Phase 4 · recruiting
- NCT05427123 — Children's Bipolar Network Treatment Trial I · recruiting
- NCT05064319 — Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders · Phase 2 · recruiting
Other GH Research Ireland Limited trials
Trials by the same sponsor.
- NCT05800860 — A Trial of GH001 in Patients With Treatment-resistant Depression · Phase 2 · completed
- 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)
- Trial protocol + status: ClinicalTrials.gov NCT05839509 (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: 18 February 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/NCT05839509.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing