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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SAGE-217
Sponsored by
Sage Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SAGE-217

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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).
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).
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

The need for re-treatment with SAGE-217 as assessed by the time to first re-treatment.
The need for re-treatment with SAGE-217 as assessed by the number of participants achieving the requirements for re-treatment.
The need for re-treatment with SAGE-217 as assessed by the number of re-treatment cycles for each participant.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 5, 2019
Last Updated
July 21, 2023
Sponsor
Sage Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT03864614
Brief Title
A Study to Evaluate SAGE-217 in Adult Participants With Major Depressive Disorder (MDD)
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 27, 2019 (Actual)
Primary Completion Date
June 22, 2023 (Actual)
Study Completion Date
June 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sage Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1543 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAGE-217
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SAGE-217
Intervention Description
SAGE-217
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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).
Description
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).
Time Frame
52 Weeks
Secondary Outcome Measure Information:
Title
The need for re-treatment with SAGE-217 as assessed by the time to first re-treatment.
Time Frame
Up to 52 weeks
Title
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
Title
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
Title
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.
Description
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.
Time Frame
Up to 52 weeks
Title
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.
Description
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.
Time Frame
Up to 52 weeks
Title
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.
Description
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.
Time Frame
Up to 52 weeks
Title
The response of initial treatment and/or re-treatment as assessed by percent of participants achieving Clinical Global Impression - Improvement (CGI-I) score.
Description
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.
Time Frame
Up to 52 weeks
Title
The response of initial treatment and/or re-treatment as assessed by change from baseline in Clinical Global Impression - Severity (CGI-S) score.
Description
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.
Time Frame
Up to 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. 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: Participant has attempted suicide associated with the current episode of MDD. Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder. Participant has had vagus nerve stimulation, electroconvulsive therapy, or has taken ketamine (including esketamine) within the current major depressive episode.
Facility Information:
Facility Name
Sage Investigational Site
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
Facility Name
Sage Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Sage Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Sage Investigational Site
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Sage Investigational Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Sage Investigational Site
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Facility Name
Sage Investigational Site
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Sage Investigational Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Sage Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Sage Investigational Site
City
Riverside
State/Province
California
ZIP/Postal Code
92503
Country
United States
Facility Name
Sage Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Sage Investigational Site
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Sage Investigational Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
Sage Investigational Site
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
Sage Investigational Site
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Sage Investigational Site
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
Sage Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Sage Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
Sage Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Sage Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32807
Country
United States
Facility Name
Sage Investigational Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32502
Country
United States
Facility Name
Sage Investigational Site
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022
Country
United States
Facility Name
Sage Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Sage Investigational Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Sage Investigational Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Sage Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60634
Country
United States
Facility Name
Sage Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Sage Investigational Site
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Sage Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Sage Investigational Site
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
Sage Investigational Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Sage Investigational Site
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Sage Investigational site
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Sage Investigational Site
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Sage Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Sage Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Facility Name
Sage Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Sage Investigational Site
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549
Country
United States
Facility Name
Sage Investigational Site
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Sage Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Sage Investigational site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
Facility Name
Sage Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Sage Investigational Site
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
Facility Name
Sage Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Sage Investigational Site
City
Plymouth Meeting
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States
Facility Name
Sage Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Sage Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Sage Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Sage Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Sage Investigational Site
City
Newport
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Facility Name
Sage Investigational Site
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Sage Investigational Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data sharing will be consistent with the Results submission policy of ClinicalTrials.gov

Learn more about this trial

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

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