Phase 2 Clinical Trial of GH001 in Bipolar II Disorder

Sponsor

GH Research Ireland Limited (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05839509

Collaborator

(none)

Enrollment

Locations

Arm

7.9

Anticipated Duration (Months)

7.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar II Disorder	Drug: GH001	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 6, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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-Methoxy-N,N-Dimethyltryptamine 5-MeO-DMT Mebufotenin

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-Methoxy-N,N-Dimethyltryptamine

5-MeO-DMT

Mebufotenin

Outcome Measures

Primary Outcome Measures

The anti-depressive effects of GH001 evaluated by the change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) assessed at Day 7 [From Baseline to 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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