Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 16 for:    sage | Major Depressive Disorder
Previous Study | Return to List | Next Study

A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03864614
Recruitment Status : Recruiting
First Posted : March 6, 2019
Last Update Posted : July 8, 2021
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Tracking Information
First Submitted Date  ICMJE February 5, 2019
First Posted Date  ICMJE March 6, 2019
Last Update Posted Date July 8, 2021
Actual Study Start Date  ICMJE February 27, 2019
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2021)
  • Safety and tolerability of the initial treatment with SAGE-217 and/or re-treatment with SAGE-217, as assessed by the incidence and severity of adverse events. [ Time Frame: 52 Weeks ]
  • Safety and tolerability of the initial treatment with SAGE-217 and/or re-treatment with SAGE-217, as assessed by the incidence of clinically significant changes from baseline in clinical laboratory measures. [ Time Frame: 52 Weeks ]
  • Safety and tolerability of the initial treatment with SAGE-217 and/or re-treatment with SAGE-217, as assessed by the incidence of clinically significant changes from baseline in vital signs. [ Time Frame: 52 Weeks ]
  • Safety and tolerability of the initial treatment with SAGE-217 and/or re-treatment with SAGE-217, as assessed by the incidence of clinically significant changes from baseline in electrocardiograms (ECGs). [ Time Frame: 52 Weeks ]
  • The safety and tolerability of the initial treatment with SAGE-217 and/or 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 ]
    The C-SSRS consists of a baseline evaluation that assesses the lifetime experience of the participants with suicidal ideation and behavior, and a post-baseline evaluation that focuses on suicidality since the last study visit. The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe).
Original Primary Outcome Measures  ICMJE
 (submitted: March 4, 2019)
  • 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 ]
  • 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2021)
  • The need for re-treatment with SAGE-217 as assessed by the time to first re-treatment. [ Time Frame: Up to 52 weeks ]
  • The need for re-treatment with SAGE-217 as assessed by the number of participants achieving the requirements for re-treatment. [ Time Frame: Up to 52 weeks ]
  • The need for re-treatment with SAGE-217 as assessed by the number of re-treatment cycles for each participant. [ Time Frame: Up to 52 weeks ]
  • 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 ]
    The 17-item HAM-D scale is used for measuring severity of depression. The HAM-D comprises individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score can range from 0 to 52, and higher scores indicate a greater degree of depression.
  • The response of initial treatment and/or re-treatment as assessed by percent of participants 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 ]
    The 17-item HAM-D scale is used for measuring severity of depression. The HAM-D comprises individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score can range from 0 to 52, and higher scores indicate a greater degree of depression.
  • The response of initial treatment and/or re-treatment as assessed by percent of participants 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 ]
    The 17-item HAM-D scale is used for measuring severity of depression. The HAM-D total score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score can range from 0 to 52, and higher scores indicate a greater degree of depression.
  • The response of initial treatment and/or re-treatment as assessed by percent of participants achieving Clinical Global Impression - Improvement (CGI-I) score. [ Time Frame: Up to 52 weeks ]
    The CGI-I employs a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. The Investigator will rate the participant's total improvement compared to baseline, whether or not it is due entirely to drug treatment. Response choices include: 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse.
  • 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 ]
    The CGI-S uses a 7-point Likert scale to rate the severity of the participant's mental illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating as 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=extremely ill.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2019)
  • The need for re-treatment with SAGE-217 as assessed by the time to first re-treatment. [ Time Frame: Up to 52 weeks ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
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 SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)
Official Title  ICMJE 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
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 participants with MDD.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE Drug: SAGE-217
SAGE-217
Study Arms  ICMJE Experimental: SAGE-217
Intervention: Drug: SAGE-217
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 7, 2021)
1550
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2019)
600
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Participant has a diagnosis of MDD as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Clinical Trial Version (SCID-5-CT), with symptoms that have been present for at least a 4-week period.
  2. Participant is in good physical health and has no clinically significant findings, as determined by the Investigator, on physical examination, 12-lead electrocardiogram (ECG), or clinical laboratory tests.
  3. Participant has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥28 and a HAM-D total score of ≥20 at Screening and Day 1 (prior to dosing).

Exclusion Criteria:

  1. Participant has attempted suicide associated with the current episode of MDD.
  2. Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
  3. Participant has had vagus nerve stimulation, electroconvulsive therapy, or has taken ketamine (including esketamine) within the current major depressive episode.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Handan Gunduz-Bruce, MD 617-949-2883 Handan.Gunduz-Bruce@sagerx.com
Listed Location Countries  ICMJE United States
Removed Location Countries Puerto Rico
 
Administrative Information
NCT Number  ICMJE NCT03864614
Other Study ID Numbers  ICMJE 217-MDD-303
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
Plan to Share IPD: No
Plan Description: Data sharing will be consistent with the Results submission policy of ClinicalTrials.gov
Responsible Party Sage Therapeutics
Study Sponsor  ICMJE Sage Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sage Therapeutics
Verification Date July 2021

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