A Study to Evaluate SAGE-547 in Patients With Severe Postpartum Depression

Status:	Recruiting
Conditions:	Depression, Depression
Therapuetic Areas:	Psychiatry / Psychology
Healthy:	No
Age Range:	18 - 45
Updated:	5/28/2016
Start Date:	November 2015
End Date:	July 2016
Contact:	Samantha Meltzer-Brody, MD
Email:	samantha_meltzer-brody@med.unc.edu

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating The Efficacy, Safety, And Pharmacokinetics Of SAGE-547 Injection 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-547 Injection in adult female subjects
diagnosed with severe postpartum depression

Key Inclusion Criteria:

- Subject either must have ceased lactating at Screening; or if still lactating at
Screening, must have already fully and permanently weaned their infant(s) from
breastmilk; or if still actively breastfeeding at Screening, must agree to cease
giving breastmilk to their infant(s) prior to receiving study drug.

- 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-IV Axis I Disorders (SCID-I)

- Subject is ≤ six months postpartum

- Subject must be amenable to IV therapy

Key Exclusion Criteria:

- Active psychosis

- Attempted suicide associated with index case of postpartum depression

- Medical history of seizures

- Medical history of bipolar disorder

Note: suicidal ideation is not an exclusion. Other protocol-defined inclusion/exclusion
criteria may apply.

We found this trial at

sites

Johns Hopkins University Women's Mood Disorders

Baltimore, Maryland 21205

Phone: 410-502-2586

from

Baltimore, MD