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.
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.