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
Miami, Florida 33155
2728
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from 98109
Miami, FL
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Atlanta, Georgia 30303
2179
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Atlanta, GA
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Baltimore, Maryland 21215
2328
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Baltimore, MD
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Baytown, Texas 77521
1907
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Baytown, TX
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Bellflower, California 90706
975
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from 98109
Bellflower, CA
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Boston, Massachusetts 02115
2485
mi
from 98109
Boston, MA
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Chandler, Arizona 85226
1131
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Chandler, AZ
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Chapel Hill, North Carolina 27514
2167
mi
from 98109
Chapel Hill, NC
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Charleston, South Carolina 29425
2423
mi
from 98109
Charleston, SC
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Charlotte, North Carolina 28211
2281
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Charlotte, NC
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Columbus, Ohio 43210
2008
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from 98109
Columbus, OH
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Dayton, Ohio 45417
1959
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from 98109
Dayton, OH
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Downingtown, Pennsylvania 19335
2346
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Downingtown, PA
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Edgewood, Kentucky 41017
1966
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from 98109
Edgewood, KY
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Flowood, Mississippi 39232
1985
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from 98109
Flowood, MS
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Gainesville, Florida 32611
2452
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Gainesville, FL
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Glen Oaks, New York 11004
2414
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Glen Oaks, NY
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Hoffman Estates, Illinois 60169
1707
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from 98109
Hoffman Estates, IL
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Houston, Texas 77058
1890
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Houston, TX
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Lemon Grove, California 91945
1065
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Lemon Grove, CA
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Little Rock, Arkansas 27702
1782
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Little Rock, AR
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Long Branch, New Jersey 07740
2395
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Long Branch, NJ
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Marlton, New Jersey 08053
2386
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Marlton, NJ
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Middleburg Heights, Ohio 44130
2019
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Middleburg Heights, OH
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Miramar, Florida 33027
2719
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Miramar, FL
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Neptune, New Jersey 07753
?
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Neptune, NJ
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Orange, California 92868
984
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Orange, CA
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Orem, Utah 84058
731
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Orem, UT
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Orlando, Florida 32803
2547
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Orlando, FL
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Owensboro, Kentucky 42303
1894
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Owensboro, KY
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Pensacola, Florida 32502
2200
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Pensacola, FL
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Philadelphia, Pennsylvania 19107
2373
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Philadelphia, PA
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Pinellas Park, Florida 33782
2521
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Pittsburgh, Pennsylvania 15212
2132
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Pittsburgh, PA
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Princeton, New Jersey 08540
2383
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Princeton, NJ
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Raleigh, North Carolina
2362
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Raleigh, NC
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Richardson, Texas 75080
1675
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Richardson, TX
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Richland, Washington 99352
171
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Richland, WA
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Rogers, Arkansas 72758
1633
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Rogers, AR
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Saint Louis, Missouri 63110
1721
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Saint Louis, MO
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San Antonio, Texas 78229
1787
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San Antonio, TX
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Ventura, California 93003
936
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Ventura, CA
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Wellington,
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Wichita, Kansas 67214
1435
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Wichita, KS
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