A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Biogen
Study ID
NCT04442503
Phase
PHASE3
Status
Completed

Conditions

  • Depression, Postpartum

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • SAGE-217 — DRUG
    SAGE-217 oral capsules.
  • Placebo — DRUG
    SAGE-217 matched-placebo oral capsules.

Study Details

The purpose of this study is to determine if treatment with SAGE-217 reduces depressive symptoms in females with severe postpartum depression (PPD) as compared to placebo.

Key Dates

Start date
Jun 8, 2020
Status verified
Nov 2023
Primary completion
Mar 15, 2022
Completion
Apr 12, 2022

Study Design

Enrollment
200 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Participants received SAGE-217 matched-placebo capsules, orally, once daily for 14 days.
  • Experimental: SAGE-217 50 mg
    Participants received SAGE-217, 50 mg, capsules, orally, once daily for 14 days.

Primary Outcome Measure

Change From Baseline (CFB) in the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15 [ Time Frame: Baseline and Day 15 ]

Locations (68)

FacilityCityStateZIPSite coordinators
Sage Investigational SiteScottsdaleArizona85258-
Sage Investigational SiteBentonvilleArkansas72712-
Sage Investigational SiteAnaheimCalifornia92805-
Sage Investigational SiteBellflowerCalifornia90706-
Sage Investigational SiteBeverly HillsCalifornia90212-
Sage Investigational SiteCosta MesaCalifornia92627-
Sage Investigational SiteImperialCalifornia92251-
Sage Investigational SiteLemon GroveCalifornia91945-
Sage Investigational SiteNorwalkCalifornia90650-
Sage Investigational SiteOceansideCalifornia92056-
Sage Investigational SiteOrangeCalifornia92866-
Sage Investigational SiteOrangeCalifornia92868-
Sage Investigational SiteRedlandsCalifornia92374-
Sage Investigational SiteSan BernardinoCalifornia92408-
Sage Investigational SiteSherman OaksCalifornia91403-
Sage Investigational SiteTorranceCalifornia90502-
Sage Investigational SiteAuroraColorado80045-
Sage Investigational SiteNorwichConnecticut06360-
Sage Investigational SiteBoynton BeachFlorida33435-
Sage Investigational SiteHialeahFlorida33012-
Sage Investigational SiteJacksonvilleFlorida32256-
Sage Investigational SiteMiamiFlorida33133-
Sage Investigational SiteMiami SpringsFlorida33166-
Sage Investigational SiteMiramarFlorida33029-
Sage Investigational SiteOrlandoFlorida32801-
Sage Investigational SiteOrlandoFlorida32807-
Sage Investigational SitePensacolaFlorida35202-
Sage Investigational SitePinellas ParkFlorida33872-
Sage Investigational SitePompano BeachFlorida33060-
Sage Investigational SiteAlpharettaGeorgia30022-
Sage Investigational SiteAtlantaGeorgia30331-
Sage Investigational SiteDecaturGeorgia30030-
Sage Investigational SiteSavannahGeorgia31405-
Sage Investigational SiteIdaho FallsIdaho83404-
Sage Investigational SiteHoffman EstatesIllinois60169-
Sage Investigational SiteLincolnwoodIllinois60712-
Sage Investigational SiteWichitaKansas67226-
Sage Investigational SiteNew OrleansLouisiana70115-
Sage Investigational SiteBostonMassachusetts02114-
Sage Investigational SiteDetroitMichigan48201-
Sage Investigational SiteFlowoodMississippi39232-
Sage Investigational SiteSaint CharlesMissouri63304-
Sage Investigational SiteSt LouisMissouri63125-
Sage Investigational SiteSt LouisMissouri63128-
Sage Investigational SiteLas VegasNevada89102-
Sage Investigational SiteMarltonNew Jersey08053-
Sage Investigational SiteBrooklynNew York11229-
Sage Investigational SiteGlen OaksNew York11004-
Sage Investigational SiteNew YorkNew York10036-
Sage Investigational SiteChapel HillNorth Carolina27599-
Sage Investigational SiteCharlotteNorth Carolina28211-
Sage Investigational SiteDenverNorth Carolina28037-
Sage Investigational SiteBeachwoodOhio44122-
Sage Investigational SiteMayfield HeightsOhio44124-
Sage Investigational SIteNorth CantonOhio44720-
Sage Investigational SiteOklahoma CityOklahoma73112-
Sage Investigational SiteAllentownPennsylvania18104-
Sage Investigational SiteMoosicPennsylvania18507-
Sage Investigational SiteProvidenceRhode Island02904-
Sage Investigational siteCharlestonSouth Carolina29425-
Sage Investigational SiteDallasTexas75231-
Sage Investigational SiteFort WorthTexas76104-
Sage Investigational SiteHoustonTexas77058-
Sage Investigational SiteLeague CityTexas77573-
Sage Investigational SiteRichardsonTexas75080-
Sage Investigational SiteSan AntonioTexas78229-
Sage Investigational SiteNorth ChesterfieldVirginia23235-
Sage Investigational SiteBellevueWashington98007-

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