A Trial of GH001 in Patients With Treatment-resistant Depression
A Randomized, Double-blind, Placebo-controlled, Phase 2b Trial With an Open-label Extension to Determine the Safety and Efficacy 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)
Mean change in MADRS from Baseline to Day 7
Time frame: Baseline to Day 7
Eligibility Criteria
Main Inclusion Criteria: 1. Is in the age range between 18 and 64 years (inclusive) at the time of informed consent; 2. Meets the trial criteria for TRD as assessed by a study psychiatrist: 1. Meets the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) criteria for single-episode major depressive disorder (MDD) or recurrent MDD, without psychotic features confirmed by the Mini-International Neuropsychiatric Interview (MINI) with current episode duration of ≤2 years; 2. The current major depressive episode must be deemed "valid" based upon the Massachusetts General Hospital State versus trait Assessability Face and Ecological validity Rule of 3Ps (MGH SAFER) criteria interview; 3. Had nonresponse (≤25% improvement) to ≥2 and ≤5 oral antidepressant treatments administered during the current episode of depression. Main Exclusion Criteria: 1. Has, based on history, psychiatric assessment, and evaluation of the MINI during the screening period, a first MDD episode…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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