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
1919
mi
from 91732
Atlanta, GA
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Allentown, Pennsylvania 18104
2355
mi
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Allentown, PA
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Amherst, New York 14226
?
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Amherst, NY
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Aventura, Florida 33027
?
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Aventura, FL
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Bellevue, Washington 98007
960
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Bellevue, WA
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Chandler, Arizona 85226
358
mi
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Chandler, AZ
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Chapel Hill, North Carolina 27514
1991
mi
from 91732
Chapel Hill, NC
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Charlottesville, Virginia 22908
2208
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Charlottesville, VA
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Corona, California 92879
?
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Corona, CA
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Decatur, Georgia 30030
1924
mi
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Decatur, GA
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Fort Worth, Texas 76104
1195
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Fort Worth, TX
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Gainesville, Florida 32611
2103
mi
from 91732
Gainesville, FL
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Hoffman Estates, Illinois 60169
1708
mi
from 91732
Hoffman Estates, IL
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Houston, Texas 77058
1358
mi
from 91732
Houston, TX
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Lake Charles, Louisiana 70629
1469
mi
from 91732
Lake Charles, LA
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Las Vegas, Nevada 89102
217
mi
from 91732
Las Vegas, NV
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Little Rock, Arkansas 27702
1463
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Little Rock, AR
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Manhasset, New York 11030
?
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Manhasset, NY
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New Orleans, Louisiana 70115
1654
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New Orleans, LA
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New York, New York 10029
2351
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New York, NY
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Oceanside, California 92056
70
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Oceanside, CA
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Oklahoma City, Oklahoma 73116
1165
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Oklahoma City, OK
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Omaha, Nebraska 68114
1301
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Omaha, NE
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Orem, Utah 84058
552
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Orem, UT
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Orlando, Florida 32803
2184
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Orlando, FL
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Owensboro, Kentucky 42303
1739
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Owensboro, KY
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Pensacola, Florida 32502
1810
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Pensacola, FL
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Pinellas Park, Florida 33782
2125
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Pinellas Park, FL
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Princeton, New Jersey 08540
2400
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Princeton, NJ
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Raleigh, North Carolina
2218
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Raleigh, NC
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Richardson, Texas 75080
1226
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Richardson, TX
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Riverside, California 92506
36
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Riverside, CA
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Saint Charles, Missouri 63304
1558
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Saint Charles, MO
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San Antonio, Texas 78229
1188
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San Antonio, TX
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San Bernardino, California 92408
?
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San Bernardino, CA
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Washington, District of Columbia 20010
2281
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Washington,
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Wildomar, California 92595
53
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Wildomar, CA
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