Phase
Condition
Depression (Major/severe)
Post-partum Depression
Depression
Treatment
GH001
Clinical Study ID
Ages 18-45 Female
Study Summary
Eligibility Criteria
Inclusion
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) atscreening.
Meets the trial criteria for PPD as assessed by a trial psychiatrist or registeredclinical psychologist.
Exclusion
Exclusion Criteria:
Has one or more first or second degree relatives with a current or prior diagnosisof bipolar disorder, psychotic disorder or other mood disorder (including MDD) withpsychotic features.
Current pregnancy resulting in termination, still-birth, pre-term delivery (beforeweek complete gestational week 37), need for intensive care therapy of mother orchild, or adoption of child away from patient.
Has taken prohibited medication or prohibited dietary supplements within thespecified timeframe prior to dosing.
Has previously experienced a significant adverse reaction to a hallucinogenic orpsychedelic 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 trialaccording to the investigator's judgment.
Patient who has a positive pregnancy test at screening or on the pretest day, ispregnant, or plans to become pregnant during the course of the trial and up to 90days after GH001 dosing.
Study Design
Connect with a study center
Amsterdam UMC
Amsterdam,
NetherlandsSite Not Available
QPS Netherlands
Groningen,
NetherlandsSite Not Available
Clerkenwell Health
London,
United KingdomSite Not Available
St. Pancras Clinical Research
London,
United KingdomSite Not Available
Sheffield Health and Social Care NHS Foundation
Sheffield,
United KingdomSite Not Available

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