A Study to Evaluate SAGE-547 in Patients With Moderate Postpartum Depression
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This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in up to 100 adult female subjects diagnosed with moderate postpartum depression
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 Start Date
Actual Primary Completion Date
September 17, 2017
Actual Study Completion Date
October 11, 2017
Resource links provided by the National Library of Medicine
Effect of SAGE-547 on depressive symptoms in subjects with moderate postpartum depression compared to placebo injection as measured by the change from baseline in Hamilton Rating Scale for Depression (HAMD) total score [ Time Frame: 3 days ]
Secondary Outcome Measures
Safety and tolerability of SAGE-547 compared with placebo as measured by the change from baseline in the incidence of AEs, vital signs, clinical laboratory evaluations, and ECG parameters [ Time Frame: 30 days ]
Safety of SAGE-547 compared to placebo as measured by the change from baseline in suicidal ideation and behavior assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) score [ Time Frame: 30 days ]
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Ages Eligible for Study:
18 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Key Inclusion Criteria:
Subject either must have ceased lactating at Screening; or if still lactating or actively breastfeeding at Screening, must agree to temporarily cease giving breastmilk to their infant(s).
Subject has had a Major Depressive Episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I)
Subject is ≤ six months postpartum
Subject must be amenable to IV therapy
Key Exclusion Criteria:
Attempted suicide associated with index case of postpartum depression
Medical history of bipolar disorder
Note: suicidal ideation is not an exclusion. Other protocol-defined inclusion/exclusion criteria may apply.