Status:
COMPLETED
Clinical Study of GH001 in Depression
Lead Sponsor:
GH Research Ireland Limited
Conditions:
Treatment Resistant Depression
Major Depressive Disorder
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
PHASE2
Brief Summary
The aim of the study is to investigate the safety of GH001 (containing 5-methoxy-dimethyltryptamine; 5-MeO-DMT), and to investigate its effects on severity of depressive symptoms, and its dose-related...
Detailed Description
Phase 1 (Part A): The primary objective of this study is to assess the safety and tolerability of single doses of GH001 (containing 5-methoxy-dimethyltryptamine; 5-MeO-DMT) in patients with TRD. The...
Eligibility Criteria
Inclusion
- Has a body mass index (BMI) in the range of 18.5 and 35.0 kg/m2 (inclusive);
- Meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) or recurrent MDD, without psychotic features confirmed by the Mini-International Neuropsychiatric Interview (MINI);
- Treatment-Resistant Depression as evaluated by the Antidepressant Treatment History Form - Short Form (ATHF-SF);
- Has outpatient status at screening and enrolment visits;
Exclusion
- Has a current or prior diagnosis of a psychiatric comorbidity that renders the patient unsuitable for the study according to a study psychiatrist or registered psychologist;
- Has received any investigational medication within the last 1 month;
- Has a current medically significant condition (e.g., severe infection) or has a history of a medically significant condition (e.g., medical history of seizure, uncontrolled hypertension, uncontrolled diabetes, severe cardiovascular disease, hepatic or renal failure, etc.) that renders the patient unsuitable for the study according to the medical supervisor's judgment;
- Takes any medication or other substance that renders the patient unsuitable for the study according to the medical supervisor's judgment;
- Has a clinically significant abnormality in physical examination, vital signs, ECG, or clinical laboratory parameters, which renders the patient unsuitable for the study according to the medical supervisor's judgment;
Key Trial Info
Start Date :
November 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04698603
Start Date
November 12 2019
End Date
November 6 2021
Last Update
August 15 2023
Active Locations (1)
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1
Clinical Trial Site
Maastricht, Netherlands