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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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 :
Terminated
(internal company decision)
First Posted : December 11, 2018
Last Update Posted : January 25, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Major Depressive Disorder Insomnia | Drug: SAGE-217 Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 87 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 |
Actual Primary Completion Date : | December 20, 2019 |
Actual Study Completion Date : | January 17, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: SAGE-217 |
Drug: SAGE-217
SAGE-217 |
Placebo Comparator: Placebo |
Drug: Placebo
Placebo |
- Change from baseline in sleep efficiency (SE) as assessed by polysomnography (PSG) [ Time Frame: 14 Days ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- Subject has a diagnosis of Insomnia that is confirmed at screening based on the DSM-5 diagnostic criteria using the SCID-5-CT.
- Subject has an Insomnia Severity Index (ISI) score ≥15 (moderate to severe insomnia).
- Subject has a MADRS score of ≥28 prior to dosingand a HAM-D total score of ≥20.
Exclusion Criteria:
- Subject has attempted suicide associated within the current episode of MDD.
- 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.
- Subject has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
- Subject has a medical history of seizures.
- Subject has active psychosis per Investigator assessment.

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
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 |
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 25, 2022 |
Last Verified: | January 2022 |
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. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |