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



Status:Completed
Conditions:Depression, Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 45
Updated:9/12/2018
Start Date:July 2016
End Date:October 19, 2017

Use our guide to learn which trials are right for you!

Trial Summary
Trial Overview
Inclusion Criteria

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

This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of
the efficacy, safety, and pharmacokinetics of two dose levels of SAGE-547 Injection in up to
120 adult female subjects diagnosed with severe postpartum depression


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:

- Active psychosis

- Attempted suicide associated with index case of postpartum depression

- Medical history of bipolar disorders, schizophrenia, and/or schizoaffective disorder.

Note: suicidal ideation is not an exclusion. Other protocol-defined inclusion/exclusion
criteria may apply.
We found this trial at
44
sites
Sage Study Site
Raleigh, North Carolina
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Sage Investigational Site
Atlanta, Georgia 30303
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Sage Investigational Site
Baltimore, Maryland 21215
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Sage Investigational Site
Baytown, Texas 77521
?
mi
from
Baytown, TX
Click here to add this to my saved trials
Sage Investigational Site
Bellflower, California 90706
?
mi
from
Bellflower, CA
Click here to add this to my saved trials
Sage Investigational Site
Boston, Massachusetts 02115
?
mi
from
Boston, MA
Click here to add this to my saved trials
Sage Investigational Site
Chandler, Arizona 85226
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
Sage Investigational Site
Chapel Hill, North Carolina 27514
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Sage Investigational Site
Charleston, South Carolina 29425
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Sage Investigational Site
Charlotte, North Carolina 28211
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Sage Investigational Site
Columbus, Ohio 43210
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Sage Investigational Site
Dayton, Ohio 45417
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Sage Investigational Site
Downingtown, Pennsylvania 19335
?
mi
from
Downingtown, PA
Click here to add this to my saved trials
Sage Investigational Site
Edgewood, Kentucky 41017
?
mi
from
Edgewood, KY
Click here to add this to my saved trials
Sage Investigational Site
Flowood, Mississippi 39232
?
mi
from
Flowood, MS
Click here to add this to my saved trials
Sage Investigational Site
Gainesville, Florida 32611
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Sage Investigational Site
Glen Oaks, New York 11004
?
mi
from
Glen Oaks, NY
Click here to add this to my saved trials
Sage Investigational Site
Hoffman Estates, Illinois 60169
?
mi
from
Hoffman Estates, IL
Click here to add this to my saved trials
Sage Investigational Site
Houston, Texas 77058
?
mi
from
Houston, TX
Click here to add this to my saved trials
Sage Investigational Site
Lemon Grove, California 91945
?
mi
from
Lemon Grove, CA
Click here to add this to my saved trials
Sage Investigational Site
Little Rock, Arkansas 27702
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Sage Investigational Site
Long Branch, New Jersey 07740
?
mi
from
Long Branch, NJ
Click here to add this to my saved trials
Sage Investigational Site
Marlton, New Jersey 08053
?
mi
from
Marlton, NJ
Click here to add this to my saved trials
Sage Investigational Site
Miami, Florida 33155
?
mi
from
Miami, FL
Click here to add this to my saved trials
Sage Investigational Site
Middleburg Heights, Ohio 44130
?
mi
from
Middleburg Heights, OH
Click here to add this to my saved trials
Sage Investigational Site
Miramar, Florida 33027
?
mi
from
Miramar, FL
Click here to add this to my saved trials
Sage Investigational Site
Neptune, New Jersey 07753
?
mi
from
Neptune, NJ
Click here to add this to my saved trials
Sage Investigational Site
Orange, California 92868
?
mi
from
Orange, CA
Click here to add this to my saved trials
Sage Investigational Site
Orem, Utah 84058
?
mi
from
Orem, UT
Click here to add this to my saved trials
Sage Investigational Site
Orlando, Florida 32803
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Sage Investigational Site
Owensboro, Kentucky 42303
?
mi
from
Owensboro, KY
Click here to add this to my saved trials
Sage Investigational Site
Pensacola, Florida 32502
?
mi
from
Pensacola, FL
Click here to add this to my saved trials
Sage Investigational Site
Philadelphia, Pennsylvania 19107
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Sage Investigational Site
Pinellas Park, Florida 33782
?
mi
from
Pinellas Park, FL
Click here to add this to my saved trials
Sage Investigational Site
Pittsburgh, Pennsylvania 15212
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Sage Investigational Site
Princeton, New Jersey 08540
?
mi
from
Princeton, NJ
Click here to add this to my saved trials
Sage Investigational Site
Richardson, Texas 75080
?
mi
from
Richardson, TX
Click here to add this to my saved trials
Sage Investigational Site
Richland, Washington 99352
?
mi
from
Richland, WA
Click here to add this to my saved trials
Sage Investigational Site
Rogers, Arkansas 72758
?
mi
from
Rogers, AR
Click here to add this to my saved trials
Sage Investigational Site
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Sage investigational Site
San Antonio, Texas 78229
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Sage Investigational Site
Ventura, California 93003
?
mi
from
Ventura, CA
Click here to add this to my saved trials
Sage Investigational Site
Wellington,
?
mi
from
Wellington,
Click here to add this to my saved trials
Sage Investigational Site
Wichita, Kansas 67214
?
mi
from
Wichita, KS
Click here to add this to my saved trials