Status:
COMPLETED
Effects Zulresso on Postpartum Psychosis
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Sage Therapeutics
Conditions:
Postpartum Psychosis
Eligibility:
FEMALE
18-45 years
Phase:
EARLY_PHASE1
Brief Summary
This is an open-label, proof of concept trial to investigate the efficacy, safety and tolerability of Zulresso (brexanolone) administered to adult female subjects diagnosed with postpartum psychosis. ...
Detailed Description
This is a single site, open label study design to evaluate the efficacy, safety and tolerability of Zulresso in female subjects diagnosed with postpartum psychosis. Participants will be consented, an...
Eligibility Criteria
Inclusion
- All participating subjects sign an informed consent form;
- Age 18-45 years old;
- Onset of affective psychosis or mania symptoms in the 3rd trimester, within 4 weeks of delivery, or within 4 weeks of weaning;
- Clinician diagnosis of affective psychosis or mania;
- ≤12 months postpartum at screening
Exclusion
- Positive pregnancy test at screening or day 1;
- Recent pregnancy did not result in a live birth;
- Subject is in renal failure;
- Subject is in hepatic failure;
- Subject is anemic (hemoglobin ≤10 g/dL);
- Untreated or inadequately treated hypothyroidism or hyperthyroidism;
- History of schizophrenia, and/or schizoaffective disorder;
- Current/active alcohol or drug abuse
Key Trial Info
Start Date :
February 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05314153
Start Date
February 23 2022
End Date
June 1 2024
Last Update
August 26 2024
Active Locations (1)
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1
UNC Hospitals
Chapel Hill, North Carolina, United States, 27514