Phase 2 Clinical Trial of GH001 in Bipolar II Disorder

This open-label, single-arm Phase II clinical trial (n=15) will study the effects of GH001 (5-MEO-DMT) on patients with bipolar II disorder experiencing a major depressive episode.

Participants will receive an individualized dosing regimen (IDR) with at least one and up to three doses of GH001 administered within a single day. The primary outcome measure is the anti-depressive effects of GH001 evaluated by the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) assessed on day seven.

Topic Bipolar Disorder Depression
Compound 5-MeO-DMT
Country Germany Netherlands
Visit trial
Status Recruiting
Results Published No
Start date 06 April 2023
End date 01 December 2023
Chance of happening 100%
Phase Phase II
Design Open
Type Interventional
Generation Second
Participants 15
Sex All
Age 18- 64
Therapy No

Trial Details

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.

NCT Number NCT05839509

Sponsors & Collaborators

GH Research
GH Research is developing several 5-MeO-DMT based therapeutic mechanisms for various mental health disorders.

Data attribution

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