Summary
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 and Adult Female Subjects with Moderate Postpartum Depression
Study Details
The purpose of this study is to test an investigational drug called SAGE-547 (allopregnanolone) to determine its effect on moderate and/or severe postpartum depression.
In this study, you will receive the study drug, SAGE-547 or placebo, by intravenous (IV) infusion (by a needle attached to a bag, inserted into a vein in your arm). It will be given in addition to other medications you may already be taking. Regardless if you are assigned to the active treatment group or to the placebo group, you will receive all other medications and treatment as per standard of medical care and as deemed most appropriate by the doctor for your condition.
This study is being carried out at up to 50 study centers in the United States and up to 128 subjects will participate. We will ask you to complete 4 study visits, including a Screening visit, a 3-day and night stay at the study center, and 2 follow-up visits. There is an additional follow-up visit at Day 12, but this visit is ONLY for women who have temporarily stopped breast feeding and are participating in the collection of expressed breast milk during the trial. Your participation in this study will last about 35 days. This will include the following:
- Screening Period: This period will occur within a five (5) day window from the time of consent.
- Treatment Period: This will consist of a 2.5 day (60 hour) infusion of SAGE-547 or placebo and 12 hours of assessments after the infusion has been stopped.
- Follow-up Period: This will be 2 visits, the first about 7 days after the start of the Treatment Period and the second about 30 days after the start of the Treatment Period.
- Follow-up visit at Day 12, only for those women that have temporarily stopped breastfeeding their child and are participating in the optional breast milk collection while participating in the trial.
Apply for study
If you would like to learn more about the different study opportunities you may call 1-800-530-0998 or for local callers please call 801-356-5555. To apply for this study fill out the online application HERE.