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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

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ClinicalTrials.gov Identifier: NCT03771664
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Tracking Information
First Submitted Date  ICMJE December 7, 2018
First Posted Date  ICMJE December 11, 2018
Last Update Posted Date July 10, 2019
Actual Study Start Date  ICMJE February 20, 2019
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2018)
Change from baseline in sleep efficiency (SE) as assessed by polysomnography (PSG) [ Time Frame: 14 Days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03771664 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2018)
  • Change from baseline of wake after sleep onset (WASO). [ Time Frame: 14 Days ]
  • Change from baseline in total sleep time (TST). [ Time Frame: 14 Days ]
  • Change from baseline in Latency to Persistent Sleep (LPS) [ Time Frame: 14 Days ]
  • Change from baseline in Number of Awakenings (NAW). [ Time Frame: 14 Days ]
  • Change from baseline in Insomnia Severity Index (ISI) [ Time Frame: 14 Days ]
  • Change from baseline in Consensus Sleep Diary - Core (CSD-C) [ Time Frame: 14 Days ]
  • Change from baseline in Clinical Global Impression - Severity (CGI-S). [ Time Frame: 28 Days ]
  • Change from baseline in the Clinical Global Impression - Improvement (CGI-I). [ Time Frame: 28 Days ]
  • Change from baseline in the 17-item HAM-D total score. [ Time Frame: 14 Days ]
  • Change from baseline in the 9-item subject-rated Patient Health Questionnaire (PHQ). [ Time Frame: 14 Days ]
  • Incidence and severity of adverse events/serious adverse events. [ Time Frame: 28 Days ]
  • Change from baseline in rapid eye movement (REM) and non-REM sleep. [ Time Frame: 14 Days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2018)
  • Change from baseline of wake after sleep onset (WASO). [ Time Frame: 14 Days ]
  • Change from baseline in total sleep time (TST). [ Time Frame: 14 Days ]
  • Change from baseline in Latency to Persistent Sleep (LPS) [ Time Frame: 14 Days ]
  • Change from baseline in Number of Awakenings (NAW). [ Time Frame: 14 Days ]
  • Change from baseline in Insomnia Severity Index (ISI) [ Time Frame: 14 Days ]
  • Change from baseline in Consensus Sleep Diary - Core (CSD-C) [ Time Frame: 14 Days ]
  • Change from baseline in Clinical Global Impression - Severity (CGI-S). [ Time Frame: 28 Days ]
  • Change from baseline in the Clinical Global Impression - Improvement (CGI-I). [ Time Frame: 28 Days ]
  • Change from baseline in the 17-item HAM-D total score. [ Time Frame: 14 Days ]
  • Change from baseline in the 9-item subject-rated Patient Health Questionnaire (PHQ). [ Time Frame: 14 Days ]
  • Incidence and severity of adverse events/serious adverse events. [ Time Frame: 28 Days ]
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 the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Subjects With Comorbid Major Depressive Disorder and Insomnia
Official Title  ICMJE 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
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
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
  • Major Depressive Disorder
  • Insomnia
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 9, 2019)
102
Original Estimated Enrollment  ICMJE
 (submitted: December 7, 2018)
88
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date May 2020   (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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shaheen Lakhan, MD, PhD 617-949-5553 shaheen.lakhan@sagerx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03771664
Other Study ID Numbers  ICMJE 217-MDD-304
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 Not Provided
Responsible Party Sage Therapeutics
Study Sponsor  ICMJE Sage Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sage Therapeutics
Verification Date July 2019

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