Effects Zulresso on Postpartum Psychosis

University of North Carolina (UNC)

Status and phase: Completed; Early Phase 1

Conditions: Postpartum Psychosis

Treatments: Drug: Brexanolone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05314153

20-0812

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Open Label - Active Drug

Experimental group

Description:

Brexanolone (zulresso) infusion arm. All patients enrolled will receive active treatment with brexanolone.

Treatment:

Drug: Brexanolone