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

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Supernus Pharmaceuticals, Inc.
Study ID
NCT03665038
Phase
PHASE3
Status
Completed

Conditions

  • Post Partum Depression

Eligibility Criteria

Sex
FEMALE
Age
15 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Sep 7, 2018
Status verified
Jul 2022
Primary completion
Jan 8, 2021
Completion
Jan 8, 2021

Study Design

Enrollment
28 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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 Measure

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From first dose of study drug up to end of follow-up period (up to Day 30) ]

Locations (17)

FacilityCityStateZIPSite coordinators
Sage Investigational SiteTempeArizona85226-
Sage Investigational SiteNorth Little RockArkansas72758-
Sage Investigational SiteMiramarFlorida33029-
Sage Investigational SiteOrlandoFlorida32807-
Sage Investigational SitePensacolaFlorida32502-
Sage Investigational SitePinellas ParkFlorida33782-
Sage Investigational SitePompano BeachFlorida33060-
Sage Investigational SiteAtlantaGeorgia30331-
Sage Investigational SiteDecaturGeorgia30030-
Sage Investigational SiteEdgewoodKentucky41017-
Sage Investigational SiteOwensboroKentucky42303-
Sage Investigational SiteFlowoodMississippi39232-
Sage Investigational SiteJacksonMississippi39216-
Sage Investigational SiteChapel HillNorth Carolina27599-
Sage Investigational SiteMiddleburg HeightsOhio44130-
Sage Investigational SiteHoustonTexas77058-
Sage Investigational SiteLeague CityTexas77573-

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