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Trial record 4 of 5 for:    sage | Post Partum Depression

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

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Sage Therapeutics
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics
ClinicalTrials.gov Identifier:
NCT02942017
First received: October 20, 2016
Last updated: August 20, 2017
Last verified: August 2017
  Purpose
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 Intervention Phase
Moderate Postpartum Depression Drug: SAGE-547 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sage Therapeutics:

Primary Outcome Measures:
  • 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:
  • 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 ]
  • 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 ]

Estimated Enrollment: 100
Study Start Date: July 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SAGE-547
Intravenous
Drug: SAGE-547
Placebo Comparator: Placebo
Intravenous
Drug: Placebo

  Eligibility

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

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02942017

Contacts
Contact: Samantha Meltzer-Brody, MD samantha_meltzer-brody@med.unc.edu

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

Additional Information:
Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT02942017     History of Changes
Other Study ID Numbers: 547-PPD-202 C
Study First Received: October 20, 2016
Last Updated: August 20, 2017

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

ClinicalTrials.gov processed this record on August 22, 2017