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

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ClinicalTrials.gov Identifier: NCT03864614
Recruitment Status : Active, not recruiting
First Posted : March 6, 2019
Last Update Posted : March 22, 2021
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 participants with MDD.

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 : 1200 participants
Allocation: N/A
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 : November 2021
Estimated Study Completion Date : November 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/or re-treatment with SAGE-217, as assessed by the incidence and severity of adverse events. [ Time Frame: 52 Weeks ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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).


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 participants 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 participant. [ 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 ]
    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.

  5. 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.

  6. 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.

  7. 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.

  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 ]
    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.



Information from the National Library of Medicine

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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. 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.

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


Locations
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Sponsors and Collaborators
Sage Therapeutics
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Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT03864614    
Other Study ID Numbers: 217-MDD-303
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: February 2021
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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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms