Clinical Study of GH001 in Depression
A Phase 1/2 Study of GH001 in Patients With Treatment-Resistant Depression
Sponsor: GH Research Ireland Limited
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Phase 1: The safety and tolerability of GH001 as a combined measure of outcomes 5 to 13.
Time frame: up to 7 days
Phase 2: The effects of GH001 on the severity of depression evaluated by the Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: up to 7 days
Secondary Endpoints
Phase 1: The effects of GH001 on the severity of depression evaluated by the Montgomery-Asberg Depression Rating Scale (MADRS)
Phase 2: The safety and tolerability of GH001 as a combined measure of outcomes 5 to 13
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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, uncontr…
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