Evaluate SAGE-547 in Female Patients With Severe Postpartum Depression
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This is an open-label proof-of-concept study designed to evaluate the safety, tolerability, PK, and efficacy of SAGE-547 Injection in adult female patients diagnosed with severe postpartum depression (PPD).
An Open-Label Proof-of-Concept Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-547 Injection in the Treatment of Adult Female Patients With Severe Postpartum Depression
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
Resource links provided by the National Library of Medicine
Safety and tolerability of SAGE-547 measured by mean changes from baseline in clinical laboratory measures, vital signs, and ECGs; physical examination; and concomitant medication usage [ Time Frame: 34 days ]
Secondary Outcome Measures :
Pharmacokinetic (PK) profile of SAGE-547 as measured by AUC, Cmax, Tmax, Css, Cavg. [ Time Frame: 3 days ]
Effects of SAGE-547 on patient symptom response evaluated by changes from baseline in Hamilton Rating Scale for Depression-17 (HAM-D-17) and individual Clinical Global Impression-Improvement (CGI-I) Scale scores [ Time Frame: 4 days ]
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Ages Eligible for Study:
18 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Adult females, 18-45 years old who experienced a Major Depressive Episode in the postpartum period beginning within the first 4 weeks following delivery
Patient has ceased lactating, or if still lactating has already fully and permanently weaned their infant; if still actively breastfeeding, patient must agree to cease giving breast milk to their infant prior to study entry
Recent history or active clinically significant manifestations of metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, dermatological, urogenital, or eyes, ears, or nose and throat (EENT) disorders