The Efficacy, Safety, and Pharmacokinetics of SAGE-547 Injection in the Treatment of Adult Female Subjects with Severe Postpartum Depression

Brief Description Of Study

To determine if SAGE-547 Injection infused intravenously reduces depressive symptoms in subjects with severe postpartum depression (PPD) compared to the placebo injection as assessed by the change in a depression rating.

Clinical Study Identifier: TX4739

Detailed Study Description

Subjects will be screened for eligibility then randomized to one of two treatment conditions (SAGE-547 or placebo). Subjects must remain as in-patients during the study Treatment Period, which is approximately 60 hours/2.5 days.

Additional Information About The Study

To qualify for this study, subjects must: Be a female aged between 18 and 45; Be in good physical health; Agree to adhere to study requirements; Temporarily cease breastfeeding her infant from just prior to receiving the study drug through 9 days after the end of infusion; Have a negative pregnancy test at Screening and Day 1 prior to infusion; Have a Major Depressive Episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery; Be no more than 6 months postpartum; Be willing to delay the use of other antidepressants or anxiety medications until the study drug infusion and 72-assessment have been completed; NOT have a known allergy to progesterone or allopregnanolone; NOT have active psychosis per Investigator assessment; NOT have a medical history of seizures; NOT have attempted suicide associated with index case of postpartum depression; NOT have a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder; NOT have a history of active alcoholism or drug addiction (including benzodiazepines) in the 12 months prior to Screening; NOT have exposure to another investigational medication or device within 30 days prior to Screening.

Contact research investigator to learn more about this study by filling out the form below.


To: Research Study Investigator
Subject: I am interested in participating in your Research Study
Dear Investigator,
I'm interested in learning more about and participating in your research study named: The Efficacy, Safety, and Pharmacokinetics of SAGE-547 Injection in the Treatment of Adult Female Subjects with Severe Postpartum Depression
I am hoping to hear back from you and discuss details of the study

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