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Completed

NCT Number: NCT03665038

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

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).

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Key information

Conditions

Post Partum Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

15 year–17 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Sage Investigational Site, Tempe, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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).
  • Participant is ≤6 months postpartum at screening.

Key Exclusion Criteria:

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

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

Treatment and study plan

Brexanolone

Drug

Administered as IV infusion.

Primary outcomes

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

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

    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.

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

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

    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)

    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).

  6. Average Drug Concentration in Plasma at Steady State During a Dosing Interval (Cavg)

    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)

    Cavg was evaluated as the time-weighted average plasma concentrations of brexanolone over the interval.

  7. Half-Life of First Elimination Phase of Brexanolone (Thalf)

    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)

    Half-life is the time required for half of the drug to be eliminated from the serum.

  8. Clearance of Brexanolone (CL/F)

    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)

    Clearance is defined as the volume of plasma from which a substance is completely removed per unit time.

  9. Steady-State of Volume of Distribution (Vss)

    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)

    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.

Sponsors and collaborators

Lead sponsor

Supernus Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Multicenter, Open-Label Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Brexanolone in the Treatment of Adolescent Female Subjects With Postpartum Depression

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 11, 2018
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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