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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 : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 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


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

Placebo Comparator: Placebo Drug: Placebo
Placebo




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 ]


Information from the National Library of Medicine

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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, with insomnia symptoms that must not have predated the symptoms of MDD by more than 10 weeks.
  3. Subject has an Insomnia Severity Index (ISI) score ≥15 (moderate to severe insomnia).
  4. Subject has a MADRS score of ≥28 prior to dosing

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.

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


Contacts
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Contact: Shaheen Lakhan, MD, PhD 617-949-5553 shaheen.lakhan@sagerx.com

Locations
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United States, Arkansas
Sage Investigational Site Recruiting
Little Rock, Arkansas, United States, 72211
Contact       clinicaltrialsinquiry@sagerx.com   
United States, California
Sage Investigational Site Recruiting
Garden Grove, California, United States, 92845
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
San Diego, California, United States, 92103
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Temecula, California, United States, 92591
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Florida
Sage Investigational Site Recruiting
Hollywood, Florida, United States, 33024
Contact       clinicaltrialsinquiry@sagerx.com   
Sage Investigational Site Recruiting
Miami, Florida, United States, 33161
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Georgia
Sage Investigational Site Recruiting
Atlanta, Georgia, United States, 30331
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Missouri
Sage Investigational Site Recruiting
Saint Louis, Missouri, United States, 63141
Contact       clinicaltrialsinquiry@sagerx.com   
United States, New Jersey
Sage Investigational Site Recruiting
Berlin, New Jersey, United States, 08009
Contact       clinicaltrialsinquiry@sagerx.com   
United States, New York
Sage Investigational Site Recruiting
New York, New York, United States, 10019
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Oregon
Sage Investigational Site Recruiting
Portland, Oregon, United States, 97214
Contact       clinicaltrialsinquiry@sagerx.com   
United States, Texas
Sage Investigational Site Recruiting
Austin, Texas, United States, 78754
Contact       clinicaltrialsinquiry@sagerx.com   
Sponsors and Collaborators
Sage Therapeutics

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Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT03771664     History of Changes
Other Study ID Numbers: 217-MDD-304
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019

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