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

Phase 3

Completed

• Conditions: Post Partum Depression
• Interventions: Drug: Brexanolone

• Registration Number: NCT03665038
• Lead Sponsor: Sage Therapeutics

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-30
• Study First Submitted QC: 2018-09-06
• Study Start: 2018-09-07
• Study First Posted: 2018-09-11
• Primary Completion: 2021-01-08
• Study Completion: 2021-01-08
• Disposition First Submitted: 2022-01-07
• Disposition First Submitted QC: 2022-01-07
• Disposition First Posted: 2022-01-11
• Status Verified: 2022-07
• Results First Submitted: 2022-07-15
• Results First Submitted QC: 2022-07-15
• Last Update Submitted: 2022-07-15
• Results First Posted: 2022-08-11
• Last Update Posted: 2022-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brexanolone	Brexanolone	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	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 Outcome Measures

Name	Time	Method
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)
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)
Clearance of Brexanolone (CL/F)	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.
Average Drug Concentration in Plasma at Steady State During a Dosing Interval (Cavg)	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.
Half-Life of First Elimination Phase of Brexanolone (Thalf)	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.
Steady-State of Volume of Distribution (Vss)	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.
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)
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)	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).

Trial Locations

Locations (1)

Sage Investigational Site; 🇺🇸 League City, Texas, United States