Evaluate SAGE-547 in Female Patients With Severe Postpartum Depression
| Status: | Completed |
|---|---|
| Conditions: | Depression, Depression, Women's Studies |
| Therapuetic Areas: | Psychiatry / Psychology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/27/2017 |
| Start Date: | September 2014 |
| End Date: | June 2015 |
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
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).
PK, and efficacy of SAGE-547 Injection in adult female patients diagnosed with severe
postpartum depression (PPD).
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Active psychosis
- Medical history of seizures
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Chapel Hill, North Carolina 27514
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