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A Study to Evaluate SAGE-217 for Prevention of Relapse in Adult Subjects With Major Depressive Disorder

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: NCT04007367
Recruitment Status : Suspended (Evaluating potential amendments to the study)
First Posted : July 5, 2019
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Tracking Information
First Submitted Date  ICMJE July 2, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date January 13, 2020
Actual Study Start Date  ICMJE August 21, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
Time to relapse during the Double-Blind (DB) Phase (days; from first dose of study drug in the DB Phase to relapse [date] during the DB Phase). [ Time Frame: Up to 275 Days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
  • Percentage of subjects who relapse during the DB Phase. [ Time Frame: Up to 275 Days ]
  • Change from baseline in the 17-item HAM-D total score at the end of each 14-day treatment period in the DB Phase. [ Time Frame: Up to 233 Days ]
  • HAM-D response at the end of each 14-day treatment period in the DB Phase, defined as a ≥50% reduction in HAM-D score from baseline. [ Time Frame: Up to 233 Days ]
  • HAM-D remission at the end of each 14-day treatment period in the DB Phase, defined as HAM-D total score ≤7. [ Time Frame: Up to 233 Days ]
  • CGI-I response, defined as "much improved" or "very much improved", at the end of each 14-day treatment period in the DB Phase. [ Time Frame: Up to 233 Days ]
  • Change from baseline in Clinical Global Impression - Severity (CGI-S) score at the end of each 14-day treatment period in the DB Phase. [ Time Frame: Up to 233 Days ]
  • Change from baseline in 9-item Patient Health Questionnaire (PHQ-9) score at the end of each 14-day treatment period in the DB Phase. [ Time Frame: Up to 233 Days ]
  • Time to relapse during the DB phase (days; from first dose of study drug in DB Phase to relapse [date] during the DB Phase) for subjects who achieved HAM-D remission in the OL Phase. [ Time Frame: Up to 275 Days ]
  • Incidence of treatment-emergent adverse events (TEAEs). [ Time Frame: Up to 331 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 for Prevention of Relapse in Adult Subjects With Major Depressive Disorder
Official Title  ICMJE A Phase 3, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of SAGE-217 With a Fixed, Repeated Treatment Regimen on Relapse Prevention in Adults With Major Depressive Disorder
Brief Summary This is a study with an open-label (OL) phase followed by a randomized, double-blind (DB), placebo-controlled phase to assess efficacy and safety of SAGE-217 on relapse prevention in adults with major depressive disorder.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: SAGE-217
    SAGE-217
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: SAGE-217
    Intervention: Drug: SAGE-217
  • Placebo Comparator: 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 Suspended
Estimated Enrollment  ICMJE
 (submitted: July 2, 2019)
546
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject has a diagnosis of MDD as diagnosed by SCID-5-CT, with symptoms that have been present for at least a 4-week period.
  2. Subject has had at least 1 prior major depressive episode (MDE) in the 5 years prior to Screening (not including the current episode).
  3. Subject is willing to delay start of any antidepressant, anxiolytic, insomnia, psychostimulant, prescription opioid regimens, and new psychotherapy (including Cognitive Behavioral Therapy for Insomnia [CBT-I]) until after study completion.

Exclusion Criteria:

  1. Subject has attempted suicide associated with the current episode of MDD
  2. Subject has treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants within the current major depressive episode (excluding antipsychotics) from two different classes for at least 4 weeks of treatment. Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ) will be used for this purpose.
  3. Subject has a positive pregnancy test at screening or on Day 1 prior to dosing.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older 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 NCT04007367
Other Study ID Numbers  ICMJE 217-MDD-302
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
Responsible Party Sage Therapeutics
Study Sponsor  ICMJE Sage Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sage Therapeutics
Verification Date January 2020

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