search
Back to results

A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder

Primary Purpose

Depressive Disorder, Major

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SAGE-217
Matching Placebo
Sertraline
Escitalopram
Citalopram
Duloxetine
Desvenlafaxine
Sponsored by
Sage Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Major Depressive Disorder, MDD, SAGE-217

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Clinical Trials Version (SCID-5-CT), with symptoms that have been present for at least a 4-week period
  • HAM-D-17 total score of ≥24 at Screening and Day 1
  • Participant 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 is willing, able, and eligible to take at least 1 of the 5 ADTs specified in the protocol (an eligible ADT is an ADT that has not been taken during the current depressive episode and for which the participant has no contraindications; further, a participant is not eligible for citalopram if escitalopram has been taken during the current depressive episode, and vice versa)

Exclusion Criteria:

  • Has attempted suicide associated with the current episode of MDD
  • Participant had onset of the current depressive episode during pregnancy or 4 weeks postpartum, or the participant has presented for screening during the 6-month postpartum period
  • Participant has treatment-resistant depression
  • History of bipolar disorder, schizophrenia, and/or schizoaffective disorder
  • Known allergy to SAGE-217, allopregnanolone, or related compounds
  • Has taken antidepressants within 30 days prior to Day 1, and/or has taken fluoxetine within 60 days prior to Day 1

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental: SAGE-217 + Assigned ADT

Active Comparator: Placebo + Assigned ADT

Arm Description

Participants will receive SAGE-217 capsules, orally, daily with an assigned ADT (sertraline, escitalopram, citalopram, duloxetine, or desvenlafaxine administered per labeled prescribing information), daily from Day 1 through 14, followed by the same ADT, per labeled prescribing information, daily for up to 42 days, with fat-containing food.

Participants will receive SAGE-217-matching placebo capsules, orally, daily with an assigned ADT (sertraline, escitalopram, citalopram, duloxetine, or desvenlafaxine administered per labeled prescribing information), daily from Day 1 through 14, followed by the same ADT, per labeled prescribing information, daily for up to 42 days, with fat-containing food.

Outcomes

Primary Outcome Measures

Change from Baseline in 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 3
HAM-D total score will be the sum of the 17 individual item scores. Items with score range of 0 to 2 include insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. Items with score range of 2 to 4 include agitation, depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), anxiety (psychic and somatic), and hypochondriasis. The total score ranges from 0 to 52, where higher score indicates more depression.

Secondary Outcome Measures

Change from Baseline in 17-item HAM-D Total Score over the Blinded Treatment Period Using Equal Weights for the Scheduled Visits
HAM-D total score will be the sum of the 17 individual item scores. Items with score range of 0 to 2 include insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. Items with score range of 2 to 4 include agitation, depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), anxiety (psychic and somatic), and hypochondriasis. The total score ranges from 0 to 52, where higher score indicates more depression.
Change from Baseline in 17-item HAM-D Total Score at Days 15 and 42
Change from Baseline in 17-item HAM-D Total Score Around the End of Blinded Treatment Using Equal Weights for the Scheduled Visits
Percentage of Participants with HAM-D Response
HAM-D response is defined as having a 50% or greater reduction from baseline in HAM-D total score.
Percentage of Participants with HAM-D Remission
HAM-D remission is defined as having a HAM-D total score of ≤7.
Change from Baseline in Clinical Global Impression - Severity (CGI-S) Score
CGI-S uses a 7-point Likert scale to rate the severity of the participant's illness at the time of assessment. Severity of mental illness is assessed using ratings 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.
Percentage of Participants with Clinical Global Impression - Improvement (CGI-I) Response
CGI-I response will be defined as having a CGI-I score of 1 (very much improved) or 2 (much improved). CGI-I employs a 7-point Likert scale to measure the overall improvement (whether or not due entirely to drug treatment) in participant's condition posttreatment. Response choices include: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. Each item has a score range of 0 to 6. MADRS total score (ranging from 0 to 60) will be sum of the 10 individual item scores. The higher MADRS scores indicate more severe depression.
Percentage of Participants with MADRS Response
MADRS response is defined as having a 50% or greater reduction from baseline in MADRS total score.
Percentage of Participants with MADRS Remission
MADRS remission is defined as having a MADRS total score of ≤10.
Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score
14-item HAM-A will be used to rate the severity of symptoms of anxiety. HAM-A total score will be the sum of the 14 individual item scores. Each of the 14 items measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Scores of 0 (not present) to 4 (very severe) are assigned, with a total score range of 0 to 56, where <17 = mild severity, 18 to 24 = mild to moderate severity, and 25 to 30 = moderate to severe severity.
Time to First HAM-D Response
HAM-D response is defined as having a 50% or greater reduction from baseline in HAM-D total score.
Change from Baseline in Depressive Symptoms Assessed by 9-item Patient Health Questionnaire (PHQ-9)
PHQ-9 is a participant-rated depressive symptom severity scale consisting of 9 individual items. Scoring is based on responses to specific questions, as follows: 0 = not at all; 1 = several days; 2 = more than half the days; and 3 = nearly every day. PHQ-9 total score will be the sum of the 9 individual item scores, where, 0 to 4 = minimal depression, 5 to 9 = mild depression, 10 to 14 = moderate depression, 15 to 19 = moderately severe depression; and 20 to 27 = severe depression.
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
Percentage of Participants with TEAEs, Graded by Severity

Full Information

First Posted
July 15, 2020
Last Updated
November 30, 2022
Sponsor
Sage Therapeutics
search

1. Study Identification

Unique Protocol Identification Number
NCT04476030
Brief Title
A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder
Official Title
A Phase 3, Randomized, Double-Blind Study Comparing the Efficacy and Safety of SAGE-217 Plus an Antidepressant Versus Placebo Plus an Antidepressant in Adults With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 16, 2020 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary purpose of this study is to evaluate the efficacy of SAGE-217 plus an ADT in the treatment of major depressive disorder (MDD) compared to placebo plus an ADT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
Major Depressive Disorder, MDD, SAGE-217

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
440 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: SAGE-217 + Assigned ADT
Arm Type
Experimental
Arm Description
Participants will receive SAGE-217 capsules, orally, daily with an assigned ADT (sertraline, escitalopram, citalopram, duloxetine, or desvenlafaxine administered per labeled prescribing information), daily from Day 1 through 14, followed by the same ADT, per labeled prescribing information, daily for up to 42 days, with fat-containing food.
Arm Title
Active Comparator: Placebo + Assigned ADT
Arm Type
Active Comparator
Arm Description
Participants will receive SAGE-217-matching placebo capsules, orally, daily with an assigned ADT (sertraline, escitalopram, citalopram, duloxetine, or desvenlafaxine administered per labeled prescribing information), daily from Day 1 through 14, followed by the same ADT, per labeled prescribing information, daily for up to 42 days, with fat-containing food.
Intervention Type
Drug
Intervention Name(s)
SAGE-217
Intervention Description
Oral capsules
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Intervention Description
Oral capsules
Intervention Type
Drug
Intervention Name(s)
Sertraline
Intervention Description
Oral tablets
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Intervention Description
Oral tablets
Intervention Type
Drug
Intervention Name(s)
Citalopram
Intervention Description
Oral tablets
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Intervention Description
Oral capsules
Intervention Type
Drug
Intervention Name(s)
Desvenlafaxine
Intervention Description
Oral tablets
Primary Outcome Measure Information:
Title
Change from Baseline in 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 3
Description
HAM-D total score will be the sum of the 17 individual item scores. Items with score range of 0 to 2 include insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. Items with score range of 2 to 4 include agitation, depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), anxiety (psychic and somatic), and hypochondriasis. The total score ranges from 0 to 52, where higher score indicates more depression.
Time Frame
Baseline and Day 3
Secondary Outcome Measure Information:
Title
Change from Baseline in 17-item HAM-D Total Score over the Blinded Treatment Period Using Equal Weights for the Scheduled Visits
Description
HAM-D total score will be the sum of the 17 individual item scores. Items with score range of 0 to 2 include insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. Items with score range of 2 to 4 include agitation, depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), anxiety (psychic and somatic), and hypochondriasis. The total score ranges from 0 to 52, where higher score indicates more depression.
Time Frame
Baseline, Days 3, 8, 12, and 15
Title
Change from Baseline in 17-item HAM-D Total Score at Days 15 and 42
Time Frame
Baseline, Days 15 and 42
Title
Change from Baseline in 17-item HAM-D Total Score Around the End of Blinded Treatment Using Equal Weights for the Scheduled Visits
Time Frame
Baseline, Days 12, 15, and 18
Title
Percentage of Participants with HAM-D Response
Description
HAM-D response is defined as having a 50% or greater reduction from baseline in HAM-D total score.
Time Frame
Days 15 and 42
Title
Percentage of Participants with HAM-D Remission
Description
HAM-D remission is defined as having a HAM-D total score of ≤7.
Time Frame
Days 15 and 42
Title
Change from Baseline in Clinical Global Impression - Severity (CGI-S) Score
Description
CGI-S uses a 7-point Likert scale to rate the severity of the participant's illness at the time of assessment. Severity of mental illness is assessed using ratings 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
Baseline and Day 15
Title
Percentage of Participants with Clinical Global Impression - Improvement (CGI-I) Response
Description
CGI-I response will be defined as having a CGI-I score of 1 (very much improved) or 2 (much improved). CGI-I employs a 7-point Likert scale to measure the overall improvement (whether or not due entirely to drug treatment) in participant's condition posttreatment. Response choices include: 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
Days 3 and 15
Title
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Description
MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. Each item has a score range of 0 to 6. MADRS total score (ranging from 0 to 60) will be sum of the 10 individual item scores. The higher MADRS scores indicate more severe depression.
Time Frame
Baseline and Day 15
Title
Percentage of Participants with MADRS Response
Description
MADRS response is defined as having a 50% or greater reduction from baseline in MADRS total score.
Time Frame
Day 15
Title
Percentage of Participants with MADRS Remission
Description
MADRS remission is defined as having a MADRS total score of ≤10.
Time Frame
Day 15
Title
Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score
Description
14-item HAM-A will be used to rate the severity of symptoms of anxiety. HAM-A total score will be the sum of the 14 individual item scores. Each of the 14 items measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Scores of 0 (not present) to 4 (very severe) are assigned, with a total score range of 0 to 56, where <17 = mild severity, 18 to 24 = mild to moderate severity, and 25 to 30 = moderate to severe severity.
Time Frame
Baseline and Day 15
Title
Time to First HAM-D Response
Description
HAM-D response is defined as having a 50% or greater reduction from baseline in HAM-D total score.
Time Frame
Up to Day 42
Title
Change from Baseline in Depressive Symptoms Assessed by 9-item Patient Health Questionnaire (PHQ-9)
Description
PHQ-9 is a participant-rated depressive symptom severity scale consisting of 9 individual items. Scoring is based on responses to specific questions, as follows: 0 = not at all; 1 = several days; 2 = more than half the days; and 3 = nearly every day. PHQ-9 total score will be the sum of the 9 individual item scores, where, 0 to 4 = minimal depression, 5 to 9 = mild depression, 10 to 14 = moderate depression, 15 to 19 = moderately severe depression; and 20 to 27 = severe depression.
Time Frame
Baseline and Day 15
Title
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame
Up to Day 42
Title
Percentage of Participants with TEAEs, Graded by Severity
Time Frame
Up to Day 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Clinical Trials Version (SCID-5-CT), with symptoms that have been present for at least a 4-week period HAM-D-17 total score of ≥24 at Screening and Day 1 Participant 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 is willing, able, and eligible to take at least 1 of the 5 ADTs specified in the protocol (an eligible ADT is an ADT that has not been taken during the current depressive episode and for which the participant has no contraindications; further, a participant is not eligible for citalopram if escitalopram has been taken during the current depressive episode, and vice versa) Exclusion Criteria: Has attempted suicide associated with the current episode of MDD Participant had onset of the current depressive episode during pregnancy or 4 weeks postpartum, or the participant has presented for screening during the 6-month postpartum period Participant has treatment-resistant depression History of bipolar disorder, schizophrenia, and/or schizoaffective disorder Known allergy to SAGE-217, allopregnanolone, or related compounds Has taken antidepressants within 30 days prior to Day 1, and/or has taken fluoxetine within 60 days prior to Day 1
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
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
Towson
State/Province
Maryland
ZIP/Postal Code
21204
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
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 Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder

We'll reach out to this number within 24 hrs