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 |
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.
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
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