Conditions: Severe Postpartum Depression
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 21
Healthy volunteers: no

Brief summary:
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 participants diagnosed with severe postpartum depression.

Detailed description:

Arms:
arm 1: Participants received infusion rates of placebo matched to SAGE-547. arm 2: Participants received a 4-hour dose titration of 30 micrograms per kilogram per hour (micrograms/kg/hr) (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours).

Interventions: intervention 1: SAGE-547 intervention 2: Placebo
Intervention descriptions: intervention 1: Administered as intravenous infusion. intervention 2: Administered as intravenous infusion.

Protocol document: