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

About this Study

This study will test the effects and safety of brexanolone in adolescent female diagnosed with postpartum depression. 

Sponsor Protocol ID:547-PPD-304
IRB Number:2019-0255
Actively Enrolling
Interventional
Phase 3
October 25, 2019
Eligibility Criteria
15 years old
17 years old
Both Male and Female
No
Yes
Yes

Inclusion Criteria1. Subject (and parent/guardian, per local regulations) has signed the appropriate informed consent form prior to any study-specific procedures being performed. 

2. Subject is ambulatory, female, and it is confirmed that she will be 15 to 17 years of age (inclusive) through completion of study drug infusion. 

3. Subject agrees to adhere to the study requirements. 

4. 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 SCID-5. 

5. Subject is ≤6 months postpartum at screening. 

6. Subject is willing at screening to delay the start of any new pharmacotherapy regimens, including antidepressant or antianxiety medication until the study drug infusion and 72-hour assessments have been completed. 

7. If the subject is taking medications administered to treat the symptoms of depression or anxiety (such as anxiolytics or antidepressants), these must be at a stable dose from 30 days prior to dosing until the completion of the 72-hour assessments. 

Exclusion Criteria1. Subject has a positive pregnancy test at screening or Day 1 (prior to initiation of the study drug infusion). 

2. Subject’s most recent pregnancy resulted in a miscarriage, still birth, or neonatal death; or subject has terminated parental rights (eg, child has been placed for adoption). 

3. Subject has end stage renal disease. 

4. Subject is in hepatic failure. 


Categories Click category to view its trials.
Pediatrics
Women's Health
Participating Locations
Grants Ferry - University Physicians
Jackson Medical Mall - UMMC Clinics
University Physicians
Contact Information
Contact Name: Sheila Belk
Phone Number: 601-984-5377
Email: sbelk@umc.edu
Principal Investigator:Wallace, Kedra M
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