A Study to Evaluate SAGE-547 in Patients With Severe Postpartum Depression



Status:Recruiting
Conditions:Depression, Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 45
Updated:5/28/2016
Start Date:November 2015
End Date:July 2016
Contact:Samantha Meltzer-Brody, MD
Email:samantha_meltzer-brody@med.unc.edu

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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

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 subjects
diagnosed with severe postpartum depression


Key Inclusion Criteria:

- Subject either must have ceased lactating at Screening; or if still lactating at
Screening, must have already fully and permanently weaned their infant(s) from
breastmilk; or if still actively breastfeeding at Screening, must agree to cease
giving breastmilk to their infant(s) prior to receiving study drug.

- 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:

- Active psychosis

- Attempted suicide associated with index case of postpartum depression

- Medical history of seizures

- Medical history of bipolar disorder

Note: suicidal ideation is not an exclusion. Other protocol-defined inclusion/exclusion
criteria may apply.
We found this trial at
14
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1100 Johnson Ferry Road
Atlanta, Georgia 30342
404-851-9934
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Phone: 617-732-4906
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Little Rock, Arkansas 72202
Principal Investigator: Zachary Stowe, MD
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Baltimore, Maryland 21205
Phone: 410-502-2586
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Chapel Hill, North Carolina 27514
Phone: 919-445-0218
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Charlotte, North Carolina 28207
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Columbus, Ohio 43210
Principal Investigator: Tamar Gur, MD
Phone: 614-685-8754
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Gainesville, FL
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Marlton, New Jersey 08053
Phone: 844-772-7465
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: C. Neil Epperson, MD
Phone: 215-573-8880
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Wichita, Kansas 67226
Principal Investigator: David Grainger, MD
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55 N Lake Ave
Worcester, Massachusetts 01655
(508) 856-8989
Principal Investigator: Kristina M Deligiannidis, MD
Phone: 774-455-4134
Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
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