A Study to Assess the Safety and Efficacy of Brexanolone in the Treatment of Adolescent Female Subjects With Postpartum Depression



Status:Recruiting
Conditions:Depression, Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:15 - 17
Updated:3/30/2019
Start Date:May 17, 2018
End Date:September 2020
Contact:Kemi Bankole, MD
Email:Kemi.Bankole@sagerx.com
Phone:617-299-8380

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A Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Brexanolone in the Treatment of Adolescent Female Subjects With Postpartum Depression

This study is a multi-center, double-blind, placebo-controlled study evaluating the efficacy,
safety, tolerability, and pharmacokinetics of Brexanolone in the treatment of adolescent
female subjects with postpartum depression.


Key Inclusion Criteria:

1. Subject either has ceased lactating at screening or, if still lactating or actively
breastfeeding at screening, must agree to temporarily cease giving breastmilk to their
infants.

2. 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-5 Disorders (SCID-5).

3. Subject is ≤6 months postpartum at screening.

Key Exclusion Criteria:

1. Active psychosis

2. Attempted suicide during current episode of PPD

3. Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.

Note: Other protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
13
sites
Rogers, Arkansas 72758
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Atlanta, Georgia 30303
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Atlanta, GA
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Chandler, Arizona 85226
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Chandler, AZ
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Chapel Hill, North Carolina 27514
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Chapel Hill, NC
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Edgewood, Kentucky 41017
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Edgewood, KY
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Flowood, Mississippi 39232
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Houston, Texas 77058
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Middleburg Heights, Ohio 44130
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Middleburg Heights, OH
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Owensboro, Kentucky 42303
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Owensboro, KY
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Pensacola, Florida 32502
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Pinellas Park, Florida 33782
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Salt Lake City, Utah 84113
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Salt Lake City, UT
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Wichita, Kansas 67214
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Wichita, KS
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