NCT03665038Phase 3Completed

A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)

Study sponsor: Supernus Pharmaceuticals, Inc. · SUPN

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2021-01-08Actual

Enrollment · participants28Actual

Source updated2025-09-15Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Post Partum Depression

Treatments or interventions studied

BrexanoloneDrug

Primary outcomes · main study measures

Read the study measures

measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs); description: An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with onset on or after the start of study drug infusion, or any worsening of a pre-existing medical condition/AE with onset on or after the start of study drug infusion.; timeFrame: From first dose of study drug up to end of follow-up period (up to Day 30)

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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