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A Study to Evaluate SAGE-217 in Adult Subjects With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT03864614
Recruitment Status : Recruiting
First Posted : March 6, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Brief Summary:
This is a phase 3, open-label, 1-year study of the safety, tolerability, and need for re-treatment with SAGE-217 in adult subjects with major depressive disorder

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label, 1-Year Study of the Safety, Tolerability, and Need for Re-Treatment With SAGE-217 in Adult Subjects With Major Depressive Disorder
Actual Study Start Date : February 27, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SAGE-217 Drug: SAGE-217
SAGE-217




Primary Outcome Measures :
  1. Safety and tolerability of the initial treatment with SAGE-217 and re-treatment with SAGE-217, as assessed by the incidence and severity of adverse events. [ Time Frame: 52 Weeks ]
  2. The safety and tolerability of the initial treatment with SAGE-217 and re-treatment with SAGE-217, as assessed by suicidal ideation and behavior using the Columbia Suicide Severity Rating Scale (C-SSRS). [ Time Frame: 52 Weeks ]

Secondary Outcome Measures :
  1. The need for re-treatment with SAGE-217 as assessed by the time to first re-treatment. [ Time Frame: Up to 52 weeks ]
  2. The need for re-treatment with SAGE-217 as assessed by the number of subjects achieving the requirements for re-treatment. [ Time Frame: Up to 52 weeks ]
  3. The need for re-treatment with SAGE-217 as assessed by the number of re-treatment cycles for each subject. [ Time Frame: Up to 52 weeks ]
  4. The response of initial treatment and/or re-treatment as assessed by change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) score. [ Time Frame: Up to 52 weeks ]
  5. The response of initial treatment and/or re-treatment as assessed by percent of subjects achieving HAM-D response at the end of each 14-day treatment period, defined as a ≥50% reduction in HAM-D score from baseline. [ Time Frame: Up to 52 weeks ]
  6. The response of initial treatment and/or re-treatment as assessed by percent of subjects achieving HAM-D remission at the end of each 14-day treatment (initial and/or re-treatment) period, defined as HAM-D total score ≤7. [ Time Frame: Up to 52 weeks ]
  7. The response of initial treatment and/or re-treatment as assessed by percent of subjects achieving Clinical Global Impression - Improvement (CGI-I) score. [ Time Frame: Up to 52 weeks ]
  8. The response of initial treatment and/or re-treatment as assessed by change from baseline in Clinical Global Impression - Severity (CGI-S) score. [ Time Frame: Up to 52 weeks ]


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Ages Eligible for Study:   18 Years to 75 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 is in good physical health and has no clinically significant findings, as determined by the Investigator, on physical examination, 12-lead ECG, or clinical laboratory tests.

Exclusion Criteria:

  1. Subject has attempted suicide associated with the current episode of MDD.
  2. Subject has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
  3. Subject has had vagus nerve stimulation, electroconvulsive therapy, or has taken ketamine (including esketamine) within the current major depressive episode.

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 ClinicalTrials.gov identifier (NCT number): NCT03864614


Contacts
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Contact: Timothy Mariano, MD, PhD, MSc (617) 949-5588 timothy.mariano@sagerx.com

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Locations
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United States, Alabama
Sage Investigational Site Recruiting
Birmingham, Alabama, United States, 35294
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Dothan, Alabama, United States, 36303
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Arizona
Sage Investigational Site Recruiting
Phoenix, Arizona, United States, 85012
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Arkansas
Sage Investigational Site Recruiting
Little Rock, Arkansas, United States, 72211
Contact       clinicaltrialsinquiry@sagerx.com   
United States, California
Sage Investigational Site Recruiting
Anaheim, California, United States, 92805
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Cerritos, California, United States, 90703
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Costa Mesa, California, United States, 92626
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Culver City, California, United States, 90230
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Encino, California, United States, 91316
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Irvine, California, United States, 92614
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Los Alamitos, California, United States, 90720
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Newport Beach, California, United States, 92660
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Oceanside, California, United States, 92056
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Riverside, California, United States, 92503
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
San Marcos, California, United States, 92078
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Santa Ana, California, United States, 92705
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Torrance, California, United States, 90502
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Upland, California, United States, 91786
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Colorado
Sage Investigational Site Recruiting
Colorado Springs, Colorado, United States, 80910
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Denver, Colorado, United States, 80209
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Connecticut
Sage Investigational Site Recruiting
Cromwell, Connecticut, United States, 06416
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
New Haven, Connecticut, United States, 06511
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Norwich, Connecticut, United States, 06360
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United States, Florida
Sage Investigational Site Recruiting
Bradenton, Florida, United States, 34201
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Brandon, Florida, United States, 33511
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Hialeah, Florida, United States, 33012
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Hialeah, Florida, United States, 33015
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Lakeland, Florida, United States, 33805
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Miami, Florida, United States, 33122
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Miami, Florida, United States, 33125
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Miami, Florida, United States, 33134
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Miami, Florida, United States, 33175
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Sage Investigational Site Recruiting
Pensacola, Florida, United States, 32502
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Tampa, Florida, United States, 33634
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Winter Park, Florida, United States, 32792
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Georgia
Sage Investigational Site Recruiting
Atlanta, Georgia, United States, 30329
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Marietta, Georgia, United States, 30060
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Savannah, Georgia, United States, 31405
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Illinois
Sage Investigational Site Recruiting
Chicago, Illinois, United States, 60634
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Chicago, Illinois, United States, 60640
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Kansas
Sage Investigational Site Recruiting
Prairie Village, Kansas, United States, 66208
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Wichita, Kansas, United States, 67214
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Kentucky
Sage Investigational Site Recruiting
Louisville, Kentucky, United States, 40202
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Louisiana
Sage Investigational Site Recruiting
Lake Charles, Louisiana, United States, 70629
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Shreveport, Louisiana, United States, 71101
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Maryland
Sage Investigational Site Recruiting
Baltimore, Maryland, United States, 21287
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Towson, Maryland, United States, 21204
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Massachusetts
Sage Investigational Site Recruiting
Methuen, Massachusetts, United States, 01844
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Missouri
Sage Investigational Site Recruiting
Saint Charles, Missouri, United States, 63304
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Nebraska
Sage Investigational Site Recruiting
Lincoln, Nebraska, United States, 68526
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Omaha, Nebraska, United States, 68134
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United States, New Jersey
Sage Investigational Site Recruiting
Cherry Hill, New Jersey, United States, 08002
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Princeton, New Jersey, United States, 08540
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United States, New Mexico
Sage Investigational Site Recruiting
Albuquerque, New Mexico, United States, 87109
Contact       clinicaltrialsinquiry@sagerx.com   
United States, New York
Sage Investigational Site Recruiting
Brooklyn, New York, United States, 11229
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Brooklyn, New York, United States, 11235
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Glen Oaks, New York, United States, 11004
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Mount Kisco, New York, United States, 10549
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
New York, New York, United States, 10017
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Sage Investigational Site Recruiting
New York, New York, United States, 10019
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United States, Ohio
Sage Investigational Site Recruiting
Shaker Heights, Ohio, United States, 44122
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Oklahoma
Sage Investigational Site Recruiting
Oklahoma City, Oklahoma, United States, 73112
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Oregon
Sage Investigational Site Recruiting
Salem, Oregon, United States, 97301
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Pennsylvania
Sage Investigational Site Recruiting
Norristown, Pennsylvania, United States, 19454
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Texas
Sage Investigational Site Recruiting
Austin, Texas, United States, 78737
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Austin, Texas, United States, 78759
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Dallas, Texas, United States, 75231
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Houston, Texas, United States, 77081
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
San Antonio, Texas, United States, 78229
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Vermont
Sage Investigational Site Recruiting
Woodstock, Vermont, United States, 05091
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Washington
Sage Investigational Site Recruiting
Bellevue, Washington, United States, 98007
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Spokane, Washington, United States, 99202
Contact       clinicaltrialsinquiry@sagerx.com   
Puerto Rico
Sage Investigational Site Recruiting
San Juan, Puerto Rico, 00918
Contact       clinicaltrialsinquiry@sagerx.com   
Sponsors and Collaborators
Sage Therapeutics

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Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT03864614     History of Changes
Other Study ID Numbers: 217-MDD-303
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data sharing will be consistent with the Results submission policy of ClinicalTrials.gov

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms