A Study to Evaluate SAGE-547 in Patients With Severe Postpartum Depression



Status:Completed
Conditions:Depression, Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 45
Updated:9/12/2018
Start Date:July 2016
End Date:October 19, 2017

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Trial Summary
Trial Overview
Inclusion Criteria

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of SAGE-547 Injection in the Treatment of Adult Female Subjects With Severe Postpartum Depression and Adult Female Subjects With Moderate Postpartum Depression

This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of
the efficacy, safety, and pharmacokinetics of two dose levels of SAGE-547 Injection in up to
120 adult female subjects diagnosed with severe postpartum depression


Key Inclusion Criteria:

- Subject either must have ceased lactating at Screening; or if still lactating or
actively breastfeeding at Screening, must agree to temporarily cease giving breastmilk
to their infant(s).

- Subject 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 DSM-IV Axis I Disorders (SCID-I)

- Subject is ≤ six months postpartum

- Subject must be amenable to IV therapy

Key Exclusion Criteria:

- Active psychosis

- Attempted suicide associated with index case of postpartum depression

- Medical history of bipolar disorders, schizophrenia, and/or schizoaffective disorder.

Note: suicidal ideation is not an exclusion. Other protocol-defined inclusion/exclusion
criteria may apply.
We found this trial at
44
sites
Sage Investigational Site
Wichita, Kansas 67214
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Sage Investigational Site
Atlanta, Georgia 30303
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Atlanta, GA
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Sage Investigational Site
Baltimore, Maryland 21215
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Baltimore, MD
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Sage Investigational Site
Baytown, Texas 77521
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Baytown, TX
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Sage Investigational Site
Bellflower, California 90706
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Bellflower, CA
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Sage Investigational Site
Boston, Massachusetts 02115
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Boston, MA
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Sage Investigational Site
Chandler, Arizona 85226
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Chandler, AZ
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Sage Investigational Site
Chapel Hill, North Carolina 27514
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Chapel Hill, NC
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Sage Investigational Site
Charleston, South Carolina 29425
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Charleston, SC
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Sage Investigational Site
Charlotte, North Carolina 28211
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Charlotte, NC
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Sage Investigational Site
Columbus, Ohio 43210
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Columbus, OH
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Sage Investigational Site
Dayton, Ohio 45417
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Dayton, OH
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Sage Investigational Site
Downingtown, Pennsylvania 19335
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Downingtown, PA
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Sage Investigational Site
Edgewood, Kentucky 41017
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Edgewood, KY
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Sage Investigational Site
Flowood, Mississippi 39232
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Flowood, MS
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Sage Investigational Site
Gainesville, Florida 32611
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Gainesville, FL
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Sage Investigational Site
Glen Oaks, New York 11004
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Glen Oaks, NY
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Sage Investigational Site
Hoffman Estates, Illinois 60169
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Hoffman Estates, IL
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Sage Investigational Site
Houston, Texas 77058
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Houston, TX
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Sage Investigational Site
Lemon Grove, California 91945
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Lemon Grove, CA
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Sage Investigational Site
Little Rock, Arkansas 27702
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Little Rock, AR
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Sage Investigational Site
Long Branch, New Jersey 07740
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Long Branch, NJ
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Sage Investigational Site
Marlton, New Jersey 08053
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Marlton, NJ
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Miami, Florida 33155
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Miami, FL
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Middleburg Heights, Ohio 44130
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Middleburg Heights, OH
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Sage Investigational Site
Miramar, Florida 33027
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Miramar, FL
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Sage Investigational Site
Neptune, New Jersey 07753
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Neptune, NJ
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Sage Investigational Site
Orange, California 92868
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Orange, CA
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Sage Investigational Site
Orem, Utah 84058
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Orem, UT
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Sage Investigational Site
Orlando, Florida 32803
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Orlando, FL
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Sage Investigational Site
Owensboro, Kentucky 42303
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Owensboro, KY
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Sage Investigational Site
Pensacola, Florida 32502
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Pensacola, FL
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Sage Investigational Site
Philadelphia, Pennsylvania 19107
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Philadelphia, PA
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Sage Investigational Site
Pinellas Park, Florida 33782
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Pinellas Park, FL
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Sage Investigational Site
Pittsburgh, Pennsylvania 15212
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Pittsburgh, PA
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Sage Investigational Site
Princeton, New Jersey 08540
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Princeton, NJ
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Sage Study Site
Raleigh, North Carolina
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Raleigh, NC
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Richardson, Texas 75080
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Richardson, TX
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Sage Investigational Site
Richland, Washington 99352
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Richland, WA
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Sage Investigational Site
Rogers, Arkansas 72758
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Rogers, AR
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Sage Investigational Site
Saint Louis, Missouri 63110
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Saint Louis, MO
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Sage investigational Site
San Antonio, Texas 78229
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San Antonio, TX
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Sage Investigational Site
Ventura, California 93003
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Ventura, CA
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Sage Investigational Site
Wellington,
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Wellington,
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