Phase 3
N=28
A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)
Post Partum Depression
Bottom Line
View on ClinicalTrials.gov: NCT03665038 ↗Enrolled (actual)
28
Serious AEs
3.6%
Results posted
Aug 2022
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 4; 3; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Brexanolone (Drug)
- Age
- Pediatric · 15+ yrs
- Sex
- Female
- Sponsor
- Supernus Pharmaceuticals, Inc.
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
4; 3; 5 | — |
| SECONDARY Area Under the Concentration-Time Curve (AUC) From Time Zero to 60 Hours (AUC0-60) |
3694.9; 3516.0 | — |
| SECONDARY AUC From Time Zero to Infinity (AUCinf) |
4125.9; 3982.2 | — |
| SECONDARY Maximum (Peak) Plasma Concentration (Cmax) |
85.31; 81.66 | — |
| SECONDARY Time at Maximum (Peak) Plasma Concentration (Tmax) |
52.20; 52.30 | — |
| SECONDARY Steady-State Drug Concentration in the Plasma During Constant-Rate Infusion (Css) |
79.4; 79.4 | — |
| SECONDARY Average Drug Concentration in Plasma at Steady State During a Dosing Interval (Cavg) |
61.59; 58.60 | — |
| SECONDARY Half-Life of First Elimination Phase of Brexanolone (Thalf) |
12.24; 12.55 | — |
| SECONDARY Clearance of Brexanolone (CL/F) |
66.86; 77.88 | — |
| SECONDARY Steady-State of Volume of Distribution (Vss) |
448.1; 588.5 | — |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03665038). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.