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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 : April 2, 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 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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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: April 2, 2019
Last Verified: March 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