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A Study to Evaluate SAGE-217 in Subjects With Severe 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.
 
ClinicalTrials.gov Identifier: NCT02978326
Recruitment Status : Completed
First Posted : November 30, 2016
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Tracking Information
First Submitted Date  ICMJE November 28, 2016
First Posted Date  ICMJE November 30, 2016
Last Update Posted Date November 20, 2019
Study Start Date  ICMJE December 2016
Actual Primary Completion Date November 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2016)
Effect of SAGE-217 on depressive symptoms in subjects with severe postpartum depression compared to placebo as assessed by the change from baseline in Hamilton Rating Scale for Depression (HAM-D) total score [ Time Frame: 14 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02978326 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2016)
  • Safety and tolerability of SAGE-217 compared to placebo as assessed by the incidence of adverse events, vital sign measurements, clinical laboratory evaluations, and electrocardiogram (ECG) parameters [ Time Frame: 75 days ]
  • Safety and tolerability of SAGE-217 compared to placebo as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 75 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate SAGE-217 in Subjects With Severe Postpartum Depression
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of SAGE-217 in the Treatment of Adult Female Subjects With Severe Postpartum Depression
Brief Summary This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the efficacy, safety and pharmacokinetics of SAGE-217 in approximately 140 adult female subjects diagnosed with severe postpartum depression.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Postpartum Depression
Intervention  ICMJE
  • Drug: SAGE-217
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: SAGE-217 dosing
    SAGE-217
    Intervention: Drug: SAGE-217
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 12, 2018)
153
Original Estimated Enrollment  ICMJE
 (submitted: November 28, 2016)
32
Actual Study Completion Date  ICMJE December 11, 2018
Actual Primary Completion Date November 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 breast milk to her 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 the Structured Clinical Interview for DSM-5 Axis I Disorders (SCID-I)
  • Subject is ≤ six months postpartum

Key Exclusion Criteria:

  • Active psychosis
  • Attempted suicide associated with current episode of postpartum depression
  • Medical history of seizures
  • Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02978326
Other Study ID Numbers  ICMJE 217-PPD-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sage Therapeutics
Study Sponsor  ICMJE Sage Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Christopher Silber, MD Sage Therapeutics
PRS Account Sage Therapeutics
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP