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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03665038
Other study ID # 547-PPD-304
Secondary ID 2017-004356-34
Status Completed
Phase Phase 3
First received
Last updated
Start date September 7, 2018
Est. completion date January 8, 2021

Study information

Verified date July 2022
Source Sage Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date January 8, 2021
Est. primary completion date January 8, 2021
Accepts healthy volunteers No
Gender Female
Age group 15 Years to 17 Years
Eligibility Key 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


Intervention

Drug:
Brexanolone
Administered as IV infusion.

Locations

Country Name City State
United States Sage Investigational Site Atlanta Georgia
United States Sage Investigational Site Chapel Hill North Carolina
United States Sage Investigational Site Decatur Georgia
United States Sage Investigational Site Edgewood Kentucky
United States Sage Investigational Site Flowood Mississippi
United States Sage Investigational Site Houston Texas
United States Sage Investigational Site Jackson Mississippi
United States Sage Investigational Site League City Texas
United States Sage Investigational Site Middleburg Heights Ohio
United States Sage Investigational Site Miramar Florida
United States Sage Investigational Site North Little Rock Arkansas
United States Sage Investigational Site Orlando Florida
United States Sage Investigational Site Owensboro Kentucky
United States Sage Investigational Site Pensacola Florida
United States Sage Investigational Site Pinellas Park Florida
United States Sage Investigational Site Pompano Beach Florida
United States Sage Investigational Site Tempe Arizona

Sponsors (1)

Lead Sponsor Collaborator
Sage Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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). 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)
Secondary 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. 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)
Secondary 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. 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)
Secondary Clearance of Brexanolone (CL/F) Clearance is defined as the volume of plasma from which a substance is completely removed per unit time. 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)
Secondary 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. 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)
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