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

NCT03665038 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 547-PPD-3042017-004356-34
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 17

Brief Summary

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).

Conditions

Post Partum Depression

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (9)

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

  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)

  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)

  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)

  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)

  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)

Study Arms (1)

Brexanolone

EXPERIMENTAL

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.

Drug: Brexanolone

Interventions

Brexanolone DRUG

Administered as IV infusion.

Brexanolone

Eligibility Criteria

• Age: 15 Years - 17 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Study Sites (17)

Sage Investigational Site

Tempe, Arizona, 85226, United States

Location

Sage Investigational Site

North Little Rock, Arkansas, 72758, United States

Location

Sage Investigational Site

Miramar, Florida, 33029, United States

Location

Sage Investigational Site

Orlando, Florida, 32807, United States

Location

Sage Investigational Site

Pensacola, Florida, 32502, United States

Location

Sage Investigational Site

Pinellas Park, Florida, 33782, United States

Location

Sage Investigational Site

Pompano Beach, Florida, 33060, United States

Location

Sage Investigational Site

Atlanta, Georgia, 30331, United States

Location

Sage Investigational Site

Decatur, Georgia, 30030, United States

Location

Sage Investigational Site

Edgewood, Kentucky, 41017, United States

Location

Sage Investigational Site

Owensboro, Kentucky, 42303, United States

Location

Sage Investigational Site

Flowood, Mississippi, 39232, United States

Location

Sage Investigational Site

Jackson, Mississippi, 39216, United States

Location

Sage Investigational Site

Chapel Hill, North Carolina, 27599, United States

Location

Sage Investigational Site

Middleburg Heights, Ohio, 44130, United States

Location

Sage Investigational Site

Houston, Texas, 77058, United States

Location

Sage Investigational Site

League City, Texas, 77573, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Depression, Postpartum

Interventions

brexanolone

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Medical Monitor
• Organization: Sage Therapeutics

medinfo@sagerx.com

(617) 299-8380

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: September 11, 2018
• Study Start: September 7, 2018
• Primary Completion: January 8, 2021
• Study Completion: January 8, 2021
• Last Updated: September 15, 2025
• Results First Posted: August 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)