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出境医 / 临床实验 / A Study to Evaluate SAGE-217 for Prevention of Relapse in Adult Subjects With Major Depressive Disorder

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: SAGE-217 Drug: Placebo Phase 3

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 546 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 21, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: SAGE-217 Drug: SAGE-217
SAGE-217
Placebo Comparator: Placebo Drug: Placebo
Placebo
Outcome Measures
Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Percentage of subjects who relapse during the DB Phase. [ Time Frame: Up to 275 Days ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. Incidence of treatment-emergent adverse events (TEAEs). [ Time Frame: Up to 331 Days ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Locations
Layout table for location information
United States, Arkansas
Sage Investigational Site
Bentonville, Arkansas, United States, 72712
United States, California
Sage Investigational Site
Bellflower, California, United States, 90706
Sage Investigational Site
Garden Grove, California, United States, 92845-2506
Sage Investigational Site
Lemon Grove, California, United States, 91945
Sage Investigational Site
Oceanside, California, United States, 92056-4500
Sage Investigational Site
Orange, California, United States, 92868-2847
Sage Investigational Site
Riverside, California, United States, 92503
Sage Investigational Site
San Diego, California, United States, 92103
Sage Investigational Site
San Marcos, California, United States, 92078
Sage Investigational Site
Sherman Oaks, California, United States, 91403-2131
United States, Florida
Sage Investigational Site
Coral Springs, Florida, United States, 33067-4644
Sage Investigational Site
Jacksonville, Florida, United States, 32256
Sage Investigational Site
Lauderhill, Florida, United States, 33319
Sage Investigational Site
Orlando, Florida, United States, 32801
United States, Georgia
Sage Investigational Site
Alpharetta, Georgia, United States, 30022
Sage Investigational Site
Atlanta, Georgia, United States, 30328
Sage Investigational Site
Atlanta, Georgia, United States, 30329
Sage Investigational Site
Atlanta, Georgia, United States, 30331
Sage Investigational Site
Decatur, Georgia, United States, 30030
United States, Illinois
Sage Investigational Site
Chicago, Illinois, United States, 60634
Sage Investigational Site
Lincolnwood, Illinois, United States, 60712
United States, Louisiana
Sage Investigational Site
Lake Charles, Louisiana, United States, 70629
United States, Maryland
Sage Investigational Site
Gaithersburg, Maryland, United States, 20877
United States, Massachusetts
Sage Investigational Site
Boston, Massachusetts, United States, 02131
Sage Investigational Site
Methuen, Massachusetts, United States, 01844
Sage Investigational Site
Watertown, Massachusetts, United States, 02472-4153
United States, Michigan
Sage Investigational Site
Ann Arbor, Michigan, United States, 48109-2700
United States, Nevada
Sage Investigational Site
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Sage Investigational Site
Berlin, New Jersey, United States, 08009
Sage Investigational Site
Cherry Hill, New Jersey, United States, 08002-3008
Sage Investigational Site
Marlton, New Jersey, United States, 08053
United States, New Mexico
Sage Investigational Site
Albuquerque, New Mexico, United States, 87109
United States, New York
Sage Investigational Site
Jamaica, New York, United States, 11432
Sage Investigational Site
New York, New York, United States, 10017
Sage Investigational Site
New York, New York, United States, 10128
Sage Investigational Site
Rochester, New York, United States, 14618-1609
United States, Ohio
Sage Investigational Site
Dayton, Ohio, United States, 454117
Sage Investigational Site
North Canton, Ohio, United States, 44720
United States, Oklahoma
Sage Investigational Site
Oklahoma City, Oklahoma, United States, 73106
United States, Pennsylvania
Sage Investigational Site
Allentown, Pennsylvania, United States, 18104-5051
United States, Tennessee
Sage Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
Sage Investigational Site
Austin, Texas, United States, 78737
Sage Investigational Site
Dallas, Texas, United States, 75231-3442
Sage Investigational Site
Richardson, Texas, United States, 75080
Sage Investigational Site
Wichita Falls, Texas, United States, 76309
United States, Washington
Sage Investigational Site
Everett, Washington, United States, 98201
Sponsors and Collaborators
Sage Therapeutics
Tracking Information
First Submitted Date  ICMJE July 2, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date February 17, 2021
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 February 2021

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

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