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

Supernus Pharmaceuticals, Inc.28 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Post Partum Depression

Interventions

BrexanoloneDRUG

Administered as IV infusion.

Eligibility

Sex: FEMALEMin age: 15 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (17)

Sage Investigational Site

Tempe, Arizona, United States

Sage Investigational Site

North Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

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.

Time frame: From first dose of study drug up to end of follow-up period (up to Day 30)

Secondary Outcomes

Area Under the Concentration-Time Curve (AUC) From Time Zero to 60 Hours (AUC0-60)

Time frame: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)

AUC From Time Zero to Infinity (AUCinf)

Time frame: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)

Maximum (Peak) Plasma Concentration (Cmax)

Time frame: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)

Time at Maximum (Peak) Plasma Concentration (Tmax)

Time frame: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)

Steady-State Drug Concentration in the Plasma During Constant-Rate Infusion (Css)

Given that brexanolone is infused to steady-state plasma concentrations, the model-predicted steady-state drug concentration in the plasma during constant-rate infusion value also represents the predicted maximum plasma concentration at the highest infused dose (90 ug/kg/h).

Data from ClinicalTrials.gov

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