CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 10 enrolled
Drug / intervention
Brexanolonedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05314153
NCT05314153Early Ph 1Completed
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Open Label Study of the Efficacy, Safety and Tolerability of Zulresso in the Treatment of Adult Women With Postpartum Psychosis

University of North Carolina, Chapel Hill·interventional·Posted Apr 6, 2022·Updated Aug 26, 2024

In Brief

A Early Phase 1 clinical trial evaluating Brexanolone for Postpartum Psychosis. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostpartum Psychosis
CountriesUnited States
CollaboratorsSage Therapeutics

Timeline

Early Ph 1CompletedFinished
2023202420252026
First PostedApr 6, 2022
Enrollment StartFeb 23, 2022
Primary CompletionJun 1, 2024
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 4.2 years ago

Interventions

Brexanolonedrug

Brexanolone 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.