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Phase 2 Clinical Trial of GH001 in Bipolar II Disorder

NCT05839509 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-02-18

No results posted yet for this study

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.

Conditions

  • Bipolar II Disorder

Interventions

DRUG

GH001

GH001 administered via inhalation

Sponsors & Collaborators

  • GH Research Ireland Limited

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Germany
  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05839509 on ClinicalTrials.gov