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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Layout table for eligibility information
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.