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Clinical Trial 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. This study will provide critical pilot data to determine whether there is similar treatment efficacy among patients with postpartum psychosis as observed to date in patients with postpartum depression.


Clinical Trial 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, and if possible, participation will be discussed with available family members. Participants will take a consent questionnaire prior to consenting to ensure the voluntary nature and understanding of study procedures. Participants will undergo a screening visit including diagnostic interviews, clinical laboratory assessments and an EKG to determine eligibility. If eligible, participants will be admitted in-patient to UNC Hospitals and administered a continuous 60-hour infusion of Zulresso using the approved FDA REMS protocol for postpartum depression. A target dose of 90 μg/kg/hour will be administered over a period of 2.5 days following a strict tapering schedule. Monitoring will occur for an additional 12 hours after the infusion. The subject will participate in 6 follow up visits at day 7 post-infusion, day 14, day 21, day 30, day 60 and day 90. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05314153
Study type Interventional
Source University of North Carolina, Chapel Hill
Contact Holly Krohn, MPH
Phone 9194450218
Email holly_krohn@med.unc.edu
Status Recruiting
Phase Early Phase 1
Start date February 23, 2022
Completion date June 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03615794 - A Study of Pregnant and Postpartum Women With and Without Mood Disorders
Completed NCT02661789 - Neuropsychobiological Correlates of Sex-steroid Hormone Manipulation in Healthy Women: a Risk Model for Depression N/A
Recruiting NCT01172106 - Impact of Family Psychoeducation on Psychosis N/A