Effects Zulresso on Postpartum Psychosis

Completed · Early Phase 1

Conditions studied: Postpartum Psychosis

In brief

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.

Key facts

Study ID

NCT05314153

Run by

University of North Carolina, Chapel Hill

People needed

10

Starts

2022-02-23

Expected to finish

2024-06-01

Last updated by the study team

2024-08-26

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UNC Hospitals — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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