A Study to Evaluate SAGE-217 in Subjects With Severe Postpartum Depression



Status:Completed
Conditions:Depression, Depression, Women's Studies
Therapuetic Areas:Psychiatry / Psychology, Reproductive
Healthy:No
Age Range:18 - 45
Updated:1/16/2019
Start Date:December 2016
End Date:December 11, 2018

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A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of SAGE-217 in the Treatment of Adult Female Subjects With Severe Postpartum Depression

This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of
the efficacy, safety and pharmacokinetics of SAGE-217 in approximately 140 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 breast
milk to her 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 the
Structured Clinical Interview for DSM-5 Axis I Disorders (SCID-I)

- Subject is ≤ six months postpartum

Key Exclusion Criteria:

- Active psychosis

- Attempted suicide associated with current episode of postpartum depression

- Medical history of seizures

- Medical history of bipolar disorder, 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
37
sites
Atlanta, Georgia 30303
436
mi
from 43215
Atlanta, GA
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Allentown, Pennsylvania 18104
399
mi
from 43215
Allentown, PA
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Amherst, New York 14226
?
mi
from 43215
Amherst, NY
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Aventura, Florida 33027
?
mi
from 43215
Aventura, FL
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Bellevue, Washington 98007
2000
mi
from 43215
Bellevue, WA
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Chandler, Arizona 85226
1654
mi
from 43215
Chandler, AZ
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Chapel Hill, North Carolina 27514
278
mi
from 43215
Chapel Hill, NC
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Charlottesville, Virginia 22908
278
mi
from 43215
Charlottesville, VA
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Corona, California 92879
?
mi
from 43215
Corona, CA
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Decatur, Georgia 30030
433
mi
from 43215
Decatur, GA
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Fort Worth, Texas 76104
938
mi
from 43215
Fort Worth, TX
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Gainesville, Florida 32611
716
mi
from 43215
Gainesville, FL
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Hoffman Estates, Illinois 60169
300
mi
from 43215
Hoffman Estates, IL
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Houston, Texas 77058
991
mi
from 43215
Houston, TX
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Lake Charles, Louisiana 70629
885
mi
from 43215
Lake Charles, LA
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Las Vegas, Nevada 89102
1756
mi
from 43215
Las Vegas, NV
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Little Rock, Arkansas 27702
623
mi
from 43215
Little Rock, AR
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Manhasset, New York 11030
?
mi
from 43215
Manhasset, NY
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New Orleans, Louisiana 70115
800
mi
from 43215
New Orleans, LA
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New York, New York 10029
442
mi
from 43215
New York, NY
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Oceanside, California 92056
1949
mi
from 43215
Oceanside, CA
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Oklahoma City, Oklahoma 73116
849
mi
from 43215
Oklahoma City, OK
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Omaha, Nebraska 68114
682
mi
from 43215
Omaha, NE
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Orem, Utah 84058
1508
mi
from 43215
Orem, UT
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Orlando, Florida 32803
795
mi
from 43215
Orlando, FL
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Owensboro, Kentucky 42303
267
mi
from 43215
Owensboro, KY
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Pensacola, Florida 32502
700
mi
from 43215
Pensacola, FL
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Pinellas Park, Florida 33782
837
mi
from 43215
Pinellas Park, FL
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Princeton, New Jersey 08540
442
mi
from 43215
Princeton, NJ
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Raleigh, North Carolina
375
mi
from 43215
Raleigh, NC
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Richardson, Texas 75080
901
mi
from 43215
Richardson, TX
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Riverside, California 92506
1929
mi
from 43215
Riverside, CA
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Saint Charles, Missouri 63304
406
mi
from 43215
Saint Charles, MO
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San Antonio, Texas 78229
1138
mi
from 43215
San Antonio, TX
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San Bernardino, California 92408
?
mi
from 43215
San Bernardino, CA
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Washington, District of Columbia 20010
327
mi
from 43215
Washington,
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Wildomar, California 92595
1933
mi
from 43215
Wildomar, CA
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