Phase 2 Clinical Trial of GH001 in Bipolar II Disorder

NCT05839509 | Terminated Phase 2

• 1 other identifier: GH001-BD-202
• Study Type: interventional
• Target: 6
• Locations: 3 countries
• Sites: 7

Brief 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

Keywords

Depression; Bipolar Disorder; 5-Methoxy-N,N-Dimethyltryptamine; 5-MeO-DMT; Mebufotenin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

GH001 Individualized Dosing Regimen

EXPERIMENTAL

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

Interventions

GH001 DRUG

GH001 administered via inhalation

Also known as: 5-Methoxy-N,N-Dimethyltryptamine, 5-MeO-DMT, Mebufotenin

GH001 Individualized Dosing Regimen

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GH Research Ireland Limited: lead

Study Sites (7)

Investigational Site

Dresden, Germany

Location

Investigational Site

Frankfurt, Germany

Location

Investigational Site

Münster, Germany

Location

Investigational Site

Leiden, Netherlands

Location

Investigational Site

Maastricht, Netherlands

Location

Investigational Site

London, United Kingdom

Location

Investigation Site

Oxford, United Kingdom

Location

MeSH Terms

Conditions

Bipolar Disorder; Depression

Interventions

Methoxydimethyltryptamines

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

N,N-Dimethyltryptamine; Tryptamines; Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Bufotenin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Serotonin

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 3, 2023
• Study Start: April 6, 2023
• Primary Completion: November 13, 2024
• Study Completion: December 5, 2024
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); GB (2); NL (2)