Phase 2 Clinical Trial of GH001 in Bipolar II Disorder

A Phase 2 Clinical Trial of GH001 in Patients with Bipolar II Disorder and a Current Major Depressive Episode

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.

Study Overview

• Status: Terminated
• Conditions: Bipolar II Disorder
• Intervention / Treatment: Drug: GH001

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Dresden, Germany
    • Investigational Site
  • Frankfurt, Germany
    • Investigational Site
  • Münster, Germany
    • Investigational Site
• Netherlands
  • Leiden, Netherlands
    • Investigational Site
  • Maastricht, Netherlands
    • Investigational Site
• United Kingdom
  • London, United Kingdom
    • Investigational Site
  • Oxford, United Kingdom
    • Investigation Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Is male or female and in the age range between 18 and 64 years (inclusive) at screening
• Has a body mass index (BMI) in the range of 18.5 and 35 kg/m2 (inclusive) at screening
• Meets the trial criteria for bipolar II disorder and is experiencing a major depressive episode, as assessed by a trial psychiatrist or registered clinical psychologist

Exclusion Criteria:

• Has bipolar II disorder with rapid cycling (four or more episodes of hypomania or depressive episodes in previous 12-month period)
• Has, based on history, psychiatric assessment, and evaluation of the MINI, a current or prior diagnosis of bipolar I disorder, a manic episode, a psychotic disorder, MDD or other mood disorder with psychotic features, obsessive compulsive disorder, PTSD, autism spectrum disorder, borderline personality disorder, schizophrenia, delusional disorder, paranoid personality disorder, schizoaffective disorder, clinically significant intellectual disability, or any other psychiatric comorbidity that renders the patient unsuitable for the trial according to the investigator's judgment
• Has one or more first degree relatives with a current or previously diagnosed psychotic disorder, bipolar I disorder or MDD with psychotic features
• Has taken prohibited medication or prohibited dietary supplements within the specified timeframe prior to dosing
• Has previously experienced a significant adverse reaction to a hallucinogenic or psychedelic drug according to the investigator's judgment
• Has a clinically significant abnormality in physical examination, vital signs, ECG, or clinical laboratory parameters which renders the patient unsuitable for the trial according to the investigator's judgment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: GH001 Individualized Dosing Regimen; GH001 (Mebufotenin, 5-Methoxy-N,N-Dimethyltryptamine) is administered via inhalation, as an IDR consisting of up to 3 increasing doses of GH001 (6 mg, 12 mg, and 18 mg), on a single day. The second and third doses are only administered if the patient did not achieve intense psychoactive effects (a peak experience [PE]) at the previously administered dose.

Drug: GH001; GH001 administered via inhalation; Other Names: 5-MeO-DMT; Mebufotenin; 5-Methoxy-N,N-Dimethyltryptamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The anti-depressive effects of GH001 evaluated by the change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) assessed at Day 7	The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. A higher MADRS score indicates more severe depression, and each item is scored from 0 to 6. The overall score ranges from 0 to 60.	From Baseline to Day 7

Collaborators and Investigators

• Sponsor: GH Research Ireland Limited

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2023
• Primary Completion (Actual): November 13, 2024
• Study Completion (Actual): December 5, 2024

Study Registration Dates

• First Submitted: April 20, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Bipolar Disorder; 5-MeO-DMT; Mebufotenin; 5-Methoxy-N,N-Dimethyltryptamine
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Psychotropic Drugs; Serotonin Antagonists; Serotonin Agents; Hallucinogens; Serotonin Receptor Agonists; N,N-Dimethyltryptamine
• Other Study ID Numbers: GH001-BD-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No