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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Trial Summary
Trial Overview
Inclusion Criteria

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
Sage Investigational Site
Wildomar, California 92595
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Wildomar, CA
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Sage Investigational Site
Allentown, Pennsylvania 18104
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Allentown, PA
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Sage Investigational Site
Amherst, New York 14226
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Amherst, NY
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Sage Investigational Site
Atlanta, Georgia 30303
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Atlanta, GA
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Sage Investigational Site
Aventura, Florida 33027
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Aventura, FL
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Sage Investigational Site
Bellevue, Washington 98007
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Bellevue, WA
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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
Charlottesville, Virginia 22908
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Charlottesville, VA
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Sage Investigational Site
Corona, California 92879
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Corona, CA
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Sage Investigational Site
Decatur, Georgia 30030
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Decatur, GA
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Sage Investigational Site
Fort Worth, Texas 76104
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Fort Worth, TX
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Sage Investigational Site
Gainesville, Florida 32611
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Gainesville, FL
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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
Lake Charles, Louisiana 70629
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Lake Charles, LA
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Sage Investigational Site
Las Vegas, Nevada 89102
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Las Vegas, NV
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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
Manhasset, New York 11030
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Manhasset, NY
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Sage Investigational Site
New Orleans, Louisiana 70115
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New Orleans, LA
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Sage Investigational Site
New York, New York 10029
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New York, NY
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Sage Investigational Site
Oceanside, California 92056
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Oceanside, CA
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Sage Investigational Site
Oklahoma City, Oklahoma 73116
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Oklahoma City, OK
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Sage Investigational Site
Omaha, Nebraska 68114
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Omaha, NE
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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
Pinellas Park, Florida 33782
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Pinellas Park, FL
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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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Sage Investigational Site
Richardson, Texas 75080
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Richardson, TX
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Sage Investigational Site
Riverside, California 92506
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Riverside, CA
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Sage Investigational Site
Saint Charles, Missouri 63304
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Saint Charles, 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
San Bernardino, California 92408
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San Bernardino, CA
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Sage Investigational Site
Washington, District of Columbia 20010
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Washington,
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