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 |
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
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
sites
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75 Francis street
Boston, Massachusetts 02115
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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University of Miami A private research university with more than 15,000 students from around the...
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Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Chapel Hill, North Carolina 27514
Phone: 919-445-0218
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Columbus, Ohio 43210
Principal Investigator: Tamar Gur, MD
Phone: 614-685-8754
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3451 Walnut St
Philadelphia, Pennsylvania 19104
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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55 N Lake Ave
Worcester, Massachusetts 01655
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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