Clinical trial NCT03665038: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post Partum Depression
Lead sponsor: Sage Therapeutics
Sponsor class: INDUSTRY
First posted: 2018-09-11
Enrollment: 28
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From first dose of study drug up to end of follow-up period (up to Day 30)
Secondary outcomes:
measure: Area Under the Concentration-Time Curve (AUC) From Time Zero to 60 Hours (AUC0-60)
timeFrame: 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)
measure: AUC From Time Zero to Infinity (AUCinf)
timeFrame: 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)
measure: Maximum (Peak) Plasma Concentration (Cmax)
timeFrame: 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)
measure: Time at Maximum (Peak) Plasma Concentration (Tmax)
timeFrame: 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)
measure: Steady-State Drug Concentration in the Plasma During Constant-Rate Infusion (Css)
timeFrame: 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)
measure: Average Drug Concentration in Plasma at Steady State During a Dosing Interval (Cavg)
timeFrame: 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)
measure: Half-Life of First Elimination Phase of Brexanolone (Thalf)
timeFrame: 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)
measure: Clearance of Brexanolone (CL/F)
timeFrame: 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)
measure: Steady-State of Volume of Distribution (Vss)
timeFrame: 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)
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Sage Investigational Site
state: Arizona
city: North Little Rock
country: United States
facility: Sage Investigational Site
state: Arkansas
city: Miramar
country: United States
facility: Sage Investigational Site
state: Florida
city: Orlando
country: United States
facility: Sage Investigational Site
state: Florida
city: Pensacola
country: United States
facility: Sage Investigational Site
state: Florida
city: Pinellas Park
country: United States
facility: Sage Investigational Site
state: Florida
city: Pompano Beach
country: United States
facility: Sage Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Sage Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Sage Investigational Site
state: Georgia
city: Edgewood
country: United States
facility: Sage Investigational Site
state: Kentucky
city: Owensboro
country: United States
facility: Sage Investigational Site
state: Kentucky
city: Flowood
country: United States
facility: Sage Investigational Site
state: Mississippi
city: Jackson
country: United States
facility: Sage Investigational Site
state: Mississippi
city: Chapel Hill
country: United States
facility: Sage Investigational Site
state: North Carolina
city: Middleburg Heights
country: United States
facility: Sage Investigational Site
state: Ohio
city: Houston
country: United States
facility: Sage Investigational Site
state: Texas
city: League City
country: United States
facility: Sage Investigational Site
state: Texas
Study officials:
References: