A Study to Evaluate SAGE-547 in Patients With Moderate 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 11, 2017

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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 SAGE-547 Injection in up to 100 adult female
subjects diagnosed with moderate 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 disorder

Note: suicidal ideation is not an exclusion. Other protocol-defined inclusion/exclusion
criteria may apply.
We found this trial at
44
sites
Baltimore, Maryland 21215
344
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Baltimore, MD
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Atlanta, Georgia 30303
436
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Atlanta, GA
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Baytown, Texas 77521
977
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Baytown, TX
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Bellflower, California 90706
1970
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Bellflower, CA
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Boston, Massachusetts 02115
643
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Boston, MA
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Chandler, Arizona 85226
1654
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Chandler, AZ
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Chapel Hill, North Carolina 27514
278
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Chapel Hill, NC
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Charleston, South Carolina 29425
525
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Charleston, SC
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Charlotte, North Carolina 28211
348
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Charlotte, NC
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Columbus, Ohio 43210
1
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Columbus, OH
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Dayton, Ohio 45417
63
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Dayton, OH
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Downingtown, Pennsylvania 19335
387
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Downingtown, PA
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Edgewood, Kentucky 41017
105
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Edgewood, KY
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Flowood, Mississippi 39232
660
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Flowood, MS
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Gainesville, Florida 32611
716
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Gainesville, FL
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Glen Oaks, New York 11004
492
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Glen Oaks, NY
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Hoffman Estates, Illinois 60169
300
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Hoffman Estates, IL
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Houston, Texas 77058
991
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Houston, TX
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Lemon Grove, California 91945
1944
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Lemon Grove, CA
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Little Rock, Arkansas 27702
623
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Little Rock, AR
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Long Branch, New Jersey 07740
427
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Long Branch, NJ
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Marlton, New Jersey 08053
429
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Marlton, NJ
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Miami, Florida 33155
995
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Miami, FL
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Middleburg Heights, Ohio 44130
115
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Miramar, Florida 33027
979
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Neptune, New Jersey 07753
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Orange, California 92868
1958
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Orange, CA
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Orem, Utah 84058
1508
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Orem, UT
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Orlando, Florida 32803
795
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Orlando, FL
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Owensboro, Kentucky 42303
267
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Pensacola, Florida 32502
700
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Pensacola, FL
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Philadelphia, Pennsylvania 19107
416
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Philadelphia, PA
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Pinellas Park, Florida 33782
837
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Pittsburgh, Pennsylvania 15212
163
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Pittsburgh, PA
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Princeton, New Jersey 08540
442
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Princeton, NJ
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Raleigh, North Carolina
375
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Raleigh, NC
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Richardson, Texas 75080
901
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Richardson, TX
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Richland, Washington 99352
1862
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Richland, WA
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Rogers, Arkansas 72758
652
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Rogers, AR
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Saint Louis, Missouri 63110
394
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Saint Louis, MO
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San Antonio, Texas 78229
1138
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Ventura, California 93003
2021
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Ventura, CA
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Wellington,
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Wichita, Kansas 67214
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Wichita, KS
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