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

Supernus Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Post Partum Depression

Treatments: Drug: Brexanolone

Study type: Interventional

Funder types: Industry

Identifiers

NCT03665038

547-PPD-304

2017-004356-34 (EudraCT Number)

Details and patient eligibility

About

This is a multi-center study evaluating the safety, tolerability, and pharmacokinetics of brexanolone in the treatment of adolescent female participants with postpartum depression (PPD).

Enrollment: 28 patients

Sex: Female

Ages: 15 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Participant has had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Axis I Disorders (SCID-5).
2. Participant is ≤6 months postpartum at screening.

Key Exclusion Criteria:

1. Active psychosis
2. Attempted suicide during current episode of PPD
3. Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Brexanolone

Experimental group

Description:

Participants will receive a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during the study.

Treatment:

Drug: Brexanolone