Phase 2 Clinical Trial of GH001 in Bipolar II Disorder

Bipolar II Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05839509
• Other study ID #: GH001-BD-202
• Status: Recruiting
• Phase: Phase 2
• Start date: April 6, 2023
• Est. completion date: December 2023

Study information

• Verified date: April 2023
• Source: GH Research Ireland Limited
• Contact: Project Manager
• Phone: + 353 1 437 8334
• Email: clinicaltrials[@]ghres.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar II Disorder
• Disease

Intervention

Drug:
• GH001
GH001 administered via inhalation

Locations

Country	Name	City	State
Germany	Investigational Site	Dresden
Netherlands	Investigational Site	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
GH Research Ireland Limited

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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