Clinical trial NCT05839509: Phase 2 Clinical Trial of GH001 in Bipolar II Disorder
Official title: A Phase 2 Clinical Trial of GH001 in Patients with Bipolar II Disorder and a Current Major Depressive Episode
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Bipolar II Disorder
Keywords: Depression
Bipolar Disorder
5-Methoxy-N,N-Dimethyltryptamine
5-MeO-DMT
Mebufotenin
Lead sponsor: GH Research Ireland Limited
Sponsor class: INDUSTRY
First posted: 2023-05-03
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The anti-depressive effects of GH001 evaluated by the change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) assessed at Day 7
timeFrame: From Baseline to Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Investigational Site
city: Frankfurt
country: Germany
facility: Investigational Site
city: Münster
country: Germany
facility: Investigational Site
city: Leiden
country: Netherlands
facility: Investigational Site
city: Maastricht
country: Netherlands
facility: Investigational Site
city: London
country: United Kingdom
facility: Investigational Site
city: Oxford
country: United Kingdom
facility: Investigation Site
Study officials:
References: