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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02942017
Recruitment Status : Completed
First Posted : October 21, 2016
Last Update Posted : September 10, 2018
Information provided by (Responsible Party):
Sage Therapeutics

Brief Summary:
This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in up to 100 adult female subjects diagnosed with moderate postpartum depression

Condition or disease Intervention/treatment Phase
Moderate Postpartum Depression Drug: SAGE-547 Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2016
Actual Primary Completion Date : September 17, 2017
Actual Study Completion Date : October 11, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: SAGE-547
Drug: SAGE-547
Placebo Comparator: Placebo
Drug: Placebo

Primary Outcome Measures :
  1. Effect of SAGE-547 on depressive symptoms in subjects with moderate postpartum depression compared to placebo injection as measured by the change from baseline in Hamilton Rating Scale for Depression (HAMD) total score [ Time Frame: 3 days ]

Secondary Outcome Measures :
  1. Safety and tolerability of SAGE-547 compared with placebo as measured by the change from baseline in the incidence of AEs, vital signs, clinical laboratory evaluations, and ECG parameters [ Time Frame: 30 days ]
  2. Safety of SAGE-547 compared to placebo as measured by the change from baseline in suicidal ideation and behavior assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) score [ Time Frame: 30 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 disorder

Note: suicidal ideation is not an exclusion. Other protocol-defined inclusion/exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02942017

  Hide Study Locations
United States, Arizona
Sage Investigational Site
Chandler, Arizona, United States, 85226
United States, Arkansas
Sage Investigational Site
Little Rock, Arkansas, United States, 72205
Sage Investigational Site
Little Rock, Arkansas, United States, 72211
Sage Investigational Site
Rogers, Arkansas, United States, 72758
United States, California
Sage Investigational Site
Bellflower, California, United States, 90706
Sage Investigational Site
Lemon Grove, California, United States, 91945
Sage Investigational Site
Orange, California, United States, 92868
Sage Investigational Site
Ventura, California, United States, 93003
United States, Florida
Sage Investigational Site
Gainesville, Florida, United States, 32607
Sage Investigational Site
Miami, Florida, United States, 33136
Sage Investigational Site
Miami, Florida, United States, 33147
Sage Investigational Site
Miramar, Florida, United States, 33027
Sage Investigational Site
Orlando, Florida, United States, 32807
Sage Investigational Site
Pensacola, Florida, United States, 32502
Sage Investigational Site
Pinellas Park, Florida, United States, 33782
United States, Georgia
Sage Investigational Site
Atlanta, Georgia, United States, 30331
Sage Investigational Site
Atlanta, Georgia, United States, 30342
United States, Illinois
Sage Investigational Site
Hoffman Estates, Illinois, United States, 60169
United States, Kansas
Sage Investigational Site
Wichita, Kansas, United States, 67226
United States, Kentucky
Sage Investigational Site
Edgewood, Kentucky, United States, 41017
Sage Investigational Site
Owensboro, Kentucky, United States, 42303
United States, Maryland
Sage Investigational Site
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Sage Investigational Site
Boston, Massachusetts, United States, 02114
Sage Investigational Site
Boston, Massachusetts, United States, 02115
United States, Mississippi
Sage Investigational Site
Flowood, Mississippi, United States, 39232
United States, Missouri
Sage Investigational Site
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Sage Investigational Site
Long Branch, New Jersey, United States, 07740
Sage Investigational Site
Marlton, New Jersey, United States, 08053
Sage Investigational Site
Neptune, New Jersey, United States, 07753
Sage Investigational Site
Princeton, New Jersey, United States, 08540
United States, New York
Sage Investigational Site
Glen Oaks, New York, United States, 11004
United States, North Carolina
Sage Investigational Site
Chapel Hill, North Carolina, United States, 27514
Sage Investigational Site
Charlotte, North Carolina, United States, 28211
Sage Investigational Site
Raleigh, North Carolina, United States, 27612
United States, Ohio
Sage Investigational Site
Columbus, Ohio, United States, 43210
Sage Investigational Site
Dayton, Ohio, United States, 45417
Sage Investigational Site
Middleburg Heights, Ohio, United States, 44130
United States, Pennsylvania
Sage Investigational Site
Downingtown, Pennsylvania, United States, 19335
Sage Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Sage Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Sage Investigational Site
Charleston, South Carolina, United States, 29425
United States, Texas
Sage Investigational Site
Baytown, Texas, United States, 77521
Sage Investigational Site
Houston, Texas, United States, 77030
Sage Investigational Site
Houston, Texas, United States, 77058
Sage Investigational Site
Richardson, Texas, United States, 75080
Sage Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
Sage Investigational Site
Orem, Utah, United States, 84058
United States, Washington
Sage Investigational Site
Richland, Washington, United States, 99352
New Zealand
Sage Investigational Site
Wellington, New Zealand, 6021
Sponsors and Collaborators
Sage Therapeutics
Study Director: Helen Colquhoun, MD Sage Therapeutics

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sage Therapeutics Identifier: NCT02942017     History of Changes
Other Study ID Numbers: 547-PPD-202 C
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications