Back to results

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

Primary Purpose

Post Partum Depression

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Brexanolone

About this trial

This is an interventional treatment trial for Post Partum Depression

Eligibility Criteria

15 Years - 17 Years (Child)FemaleDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brexanolone

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

AUC From Time Zero to Infinity (AUCinf)

Maximum (Peak) Plasma Concentration (Cmax)

Time at Maximum (Peak) Plasma Concentration (Tmax)

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).

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

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

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

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

Clearance of Brexanolone (CL/F)

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

Steady-State of Volume of Distribution (Vss)

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.

Full Information

NCT ID

NCT03665038

First Posted

April 30, 2018

Last Updated

July 15, 2022

Sponsor

Sage Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT03665038

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

September 7, 2018 (Actual)

Primary Completion Date

January 8, 2021 (Actual)

Study Completion Date

January 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sage Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Partum Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Brexanolone

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Brexanolone

Intervention Description

Administered as IV infusion.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Time Frame