Phase 2 Clinical Trial of GH001 in Bipolar II Disorder

Study Overview
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Brief Summary
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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.

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

Conditions
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Bipolar II Disorder

Intervention / Treatment
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* Drug: GH001


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GH001 Individualized Dosing Regimen<br>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<br>* GH001 administered via inhalation<br>* Other names: Mebufotenin;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Bipolar Disorder, 5-Methoxy-N,N-Dimethyltryptamine, 5-MeO-DMT, Mebufotenin