Effects Zulresso on Postpartum Psychosis
Part of paid clinical trials in Chapel Hill, North Carolina.
- Sponsor
- University of North Carolina, Chapel Hill
- Study ID
- NCT05314153
- Phase
- EARLY_PHASE1
- Status
- Completed
Conditions
- Postpartum Psychosis
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 45 Years
- Healthy Volunteers
- Not accepted
Interventions
- Brexanolone — DRUGBrexanolone injection is an Federal Drug Administration (FDA)-approved drug to treat postpartum depression. It is administered via continuous intravenous infusion over a 60-hour time period.
Study Details
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 Dates
- Start date
- Feb 23, 2022
- Status verified
- Apr 2024
- Primary completion
- Jun 1, 2024
- Completion
- Jun 1, 2024
Study Design
- Enrollment
- 10 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Open Label - Active DrugBrexanolone (zulresso) infusion arm. All patients enrolled will receive active treatment with brexanolone.
Primary Outcome Measure
Change in Positive and Negative Syndrome Scale (PANSS) score [ Time Frame: Baseline to post-treatment day 7 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UNC Hospitals | Chapel Hill | North Carolina | 27514 | - |
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