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A Study to Evaluate the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Subjects With Comorbid Major Depressive Disorder and Insomnia

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: NCT03771664
Recruitment Status : Suspended (Evaluating potential amendments to the study)
First Posted : December 11, 2018
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Study Description
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Brief Summary:
This study is a randomized, double-blind, placebo-controlled study of the safety, tolerability, and efficacy of SAGE-217 compared to placebo in adult subjects with comorbid major depressive disorder and insomnia

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Subjects With Comorbid Major Depressive Disorder and Insomnia
Actual Study Start Date : February 20, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SAGE-217 Drug: SAGE-217
SAGE-217
Placebo Comparator: Placebo Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in sleep efficiency (SE) as assessed by polysomnography (PSG) [ Time Frame: 14 Days ]

Secondary Outcome Measures :
  1. Change from baseline of wake after sleep onset (WASO). [ Time Frame: 14 Days ]
  2. Change from baseline in total sleep time (TST). [ Time Frame: 14 Days ]
  3. Change from baseline in Latency to Persistent Sleep (LPS) [ Time Frame: 14 Days ]
  4. Change from baseline in Number of Awakenings (NAW). [ Time Frame: 14 Days ]
  5. Change from baseline in Insomnia Severity Index (ISI) [ Time Frame: 14 Days ]
  6. Change from baseline in Consensus Sleep Diary - Core (CSD-C) [ Time Frame: 14 Days ]
  7. Change from baseline in Clinical Global Impression - Severity (CGI-S). [ Time Frame: 28 Days ]
  8. Change from baseline in the Clinical Global Impression - Improvement (CGI-I). [ Time Frame: 28 Days ]
  9. Change from baseline in the 17-item HAM-D total score. [ Time Frame: 14 Days ]
  10. Change from baseline in the 9-item subject-rated Patient Health Questionnaire (PHQ). [ Time Frame: 14 Days ]
  11. Incidence and severity of adverse events/serious adverse events. [ Time Frame: 28 Days ]
  12. Change from baseline in rapid eye movement (REM) and non-REM sleep. [ Time Frame: 14 Days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (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 a diagnosis of Insomnia that is confirmed at screening based on the DSM-5 diagnostic criteria using the SCID-5-CT.
  3. Subject has an Insomnia Severity Index (ISI) score ≥15 (moderate to severe insomnia).
  4. Subject has a MADRS score of ≥28 prior to dosingand a HAM-D total score of ≥20.

Exclusion Criteria:

  1. Subject has attempted suicide associated within the current episode of MDD.
  2. Subject had onset of the current depressive episode during pregnancy or 4 weeks postpartum, or the subject has presented for screening during the 6-month postpartum period.
  3. Subject has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
  4. Subject has a medical history of seizures.
  5. Subject has active psychosis per Investigator assessment.
Contacts and Locations
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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): NCT03771664


Locations
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United States, Arkansas
Sage Investigational Site
Little Rock, Arkansas, United States, 72211
Sage Investigational Site
Rogers, Arkansas, United States, 72758
United States, California
Sage Investigational Site
Garden Grove, California, United States, 92845
Sage Investigational Site
Oceanside, California, United States, 92056
Sage Investigational Site
San Diego, California, United States, 92103
Sage Investigational Site
Temecula, California, United States, 92591
United States, Florida
Sage Investigational Site
Fort Myers, Florida, United States, 33912
Sage Investigational Site
Hollywood, Florida, United States, 33024
Sage Investigational Site
Miami Lakes, Florida, United States, 33016
Sage Investigational Site
North Miami, Florida, United States, 33161
United States, Georgia
Sage Investigational Site
Atlanta, Georgia, United States, 30331
Sage Investigational Site
Atlanta, Georgia, United States, 30342
Sage Investigational Site
Decatur, Georgia, United States, 30030
United States, Illinois
Sage Investigational Site
Chicago, Illinois, United States, 60634
United States, Louisiana
Sage Investigational Site
Lake Charles, Louisiana, United States, 70629
United States, Mississippi
Sage Investigational Site
Flowood, Mississippi, United States, 39232
United States, Missouri
Sage Investigational Site
Saint Louis, Missouri, United States, 63141
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
United States, New Mexico
Sage Investigational Site
Albuquerque, New Mexico, United States, 87109
United States, New York
Sage Investigational Site
Brooklyn, New York, United States, 11235
Sage Investigational Site
New York, New York, United States, 10019
United States, Ohio
Sage Investigational Site
Cincinnati, Ohio, United States, 45212
Sage Investigational Site
Dayton, Ohio, United States, 45417
United States, Oklahoma
Sage Investigational Site
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Sage Investigational Site
Salem, Oregon, United States, 97301
United States, South Carolina
Sage Investigational Site
Charleston, South Carolina, United States, 29407
United States, Texas
Sage Investigational Site
Austin, Texas, United States, 78754
Sponsors and Collaborators
Sage Therapeutics
More Information
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Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT03771664    
Other Study ID Numbers: 217-MDD-304
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020

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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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Sleep Initiation and Maintenance Disorders
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
 Behavioral Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases