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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05839509
Other study ID # GH001-BD-202
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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