19 Apr Skylark Postpartum Depression Study
To determine if treatment with SAGE-217 reduces depressive symptoms in women with postpartum depression (PPD) compared to placebo.
To determine if treatment with SAGE-217 reduces anxiety symptoms compared to placebo.
To assess self-report of depressive symptoms
To evaluate the safety and tolerability of SAGE-217
This is a PHASE 3 study.
Duration of participation will be up to 76 days, including screening, treatment period, and follow-up period.
Ambulatory females between 18 and 45 years of age, inclusive
Participant must be in good physical health
Cannot be participating in night shift work
Participant has ceased lactating or agrees not to provide breastmilk to infant(s) from just prior to Day 1 of receiving medication until 7 days after last dose of medication.
Cannot be pregnant during study
Participant is no more than 12 months postpartum
(142) 545-3040 x4____
Additional Study Details
Full Study Title
A Randomized, Double-Blind, Placebo-controlled Study Evaluating the Efficacy and Safety of SAGE-217 i the Treatment of Adults with Severe Postpartum Depression
Accepts Healthy Volunteers?
Northwest Clinical Research Center
1951 152nd PL NE 200
Bellevue, Washington 98007