Effects Zulresso on Postpartum Psychosis

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: Sage Therapeutics
• Treatments: Brexanolone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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