Phase 2 Clinical Trial of GH001 in Postpartum Depression
A Phase 2 Clinical Trial of GH001 in Patients with Postpartum 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)
The anti-depressive effects of GH001 evaluated by the change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) assessed at Day 7
Time frame: From Baseline to Day 7
Eligibility Criteria
Inclusion Criteria: * Is female and in the age range between 18 and 45 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 PPD as assessed by a trial psychiatrist or registered clinical psychologist. Exclusion Criteria: * Has one or more first or second degree relatives with a current or prior diagnosis of bipolar disorder, psychotic disorder or other mood disorder (including MDD) with psychotic features. * Current pregnancy resulting in termination, still-birth, pre-term delivery (before week complete gestational week 37), need for intensive care therapy of mother or child, or adoption of child away from patient. * 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 clinical…
Read full criteria on CT.gov →✦ Analyst Commentary
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