drugset / Trial / NCT05839509

Phase 2 Clinical Trial of GH001 in Bipolar II Disorder

NCT05839509

Phase 2 Terminated 6 enrolled GH Research Ireland Limited
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2023-04-06
Primary completion
2024-11-13
Completion
2024-12-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Mebufotenin Small molecule 6 mg Inhaled
Subject Mebufotenin Small molecule 12 mg Inhaled
Subject Mebufotenin Small molecule 18 mg Inhaled

Indications