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A Study to Evaluate the Efficacy of Sage-217 in the Treatment of Adult Participants With Major Depressive Disorder (MDD)

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ClinicalTrials.gov Identifier: NCT04442490
Recruitment Status : Completed
First Posted : June 22, 2020
Last Update Posted : May 25, 2021
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Brief Summary:
The purpose of this study to evaluate the efficacy of SAGE-217 in the treatment of participants with MDD.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: SAGE-217 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 543 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of SAGE-217 in the Treatment of Adult Subjects With Major Depressive Disorder
Actual Study Start Date : May 7, 2020
Actual Primary Completion Date : March 26, 2021
Actual Study Completion Date : April 21, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SAGE-217
Participants will receive SAGE-217 capsules, once daily for 14 days. The dose may be decreased based on safety and tolerability.
Drug: SAGE-217
SAGE-217 oral capsules.

Placebo Comparator: SAGE-217 Matched Placebo
Participants will receive SAGE-217 matched-placebo capsules, once daily for 14 days.
Drug: Placebo
SAGE-217 matched-placebo oral capsules.




Primary Outcome Measures :
  1. Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15 [ Time Frame: Baseline and Day 15 ]
    The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=none/absent and 4=most severe. The total score is the sum of individual items, ranging from 0 to 52; where a higher score indicates more depression.


Secondary Outcome Measures :
  1. Clinical Global Impression - Severity (CGI-S) Score [ Time Frame: Day 15 ]
    The CGI-S is a 7-point Likert scale to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. A participant is assessed on severity of mental illness at the time of rating as 1=normal, not at all ill; 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7= among the most extremely ill participants.

  2. HAM-D Total Score [ Time Frame: Baseline and Days 3, 28, and 42 ]
    The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=none/absent and 4=most severe. The total score is the sum of individual items, ranging from 0 to 52; where a higher score indicates more depression.

  3. Percentage of Participants With HAM-D Response [ Time Frame: Days 15 and 42 ]
    The time to response is defined as time from first administration of study drug to the time when ≥50% reduction in HAM-D score from baseline is achieved.

  4. Percentage of Participants With HAM-D Remission [ Time Frame: Days 15 and 42 ]
    HAM-D remission is defined as HAM-D total score ≤7.

  5. Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response [ Time Frame: Day 15 ]
    CGI-I response is defined as having a CGI-I score of "very much improved" or "much improved." The CGI-I employs a 7-point Likert scale to measure the overall improvement in the 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.

  6. Montgomery Åsberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Day 15 ]
    The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. Each item is rated on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression.

  7. Hamilton Rating Scale for Anxiety (HAM-A) Total Score [ Time Frame: Day 15 ]
    The 14-item HAM-A is comprised of a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). The HAM-A total score will be calculated as the sum of the 14 individual item scores. The scoring for HAM-A is calculated by assigning scores of 0 (not present) to 4 (very severe), with a total score range of 0 to 56.

  8. Time to First HAM-D Response [ Time Frame: Days 1, 3, 8, 12, 15, 21, 28, 35 and 42 ]
    The time to response is defined as time from first administration of study drug to the time when ≥50% reduction in HAM-D score from baseline is achieved.

  9. Change From Baseline in PRO Measures of Health-Related Quality of Life, as Assessed by the 36-item Short Form version 2 (SF-36v2) Score [ Time Frame: Baseline and Days 1, 8, 15, 28 and 42 ]
    Participant's health will be assessed using Patient-reported outcome (PRO) health related quality of life (HRQOL) SF-36 V2. The SF-36v2 is a 36-item measure including eight health dimensions which are four physical health status domains and four mental health status domains. Scores on each item are summed and averaged (range = 0 "worst"-100 "best"). Higher SF-36v2 scores will indicate a better state of health.

  10. Change From Baseline in PRO Measures of Depressive Symptoms, as Assessed by the 9-item Patient Health Questionnaire (PHQ-9) Score [ Time Frame: Baseline and Days 1, 8, 15, 28 and 42 ]
    The PHQ-9 is a participant-rated depressive symptom severity scale where scoring is based on responses to specific questions. The score will be calculated as the sum of the 9 individual item scores. The PHQ-9 total score ranges from 1 to 27 with a higher score indicating more depression.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participant with diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and 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 has a Hamilton Rating Scale for Depression (HAM-D) total score ≥24 at screening and Day 1 (prior to dosing).
  3. Participants taking antidepressants must have been taking these medications at the same dose for at least 60 days prior to Day 1. Participants who have stopped taking antidepressants within 60 days must have stopped for longer than 5 half-lives of the antidepressant prior to Day 1. Participants receiving psychotherapy must have been receiving therapy on a regular schedule for at least 60 days prior to Day 1.
  4. Participant is willing to delay start of other antidepressant or antianxiety medications and any new pharmacotherapy regimens, including as-needed benzodiazepine anxiolytics and sleep aids, until after completion of the Day 42 visit.

Exclusion Criteria:

  1. Participant is currently at significant risk of suicide, as judged by the Investigator, or has attempted suicide associated with the current episode of MDD.
  2. Participant has 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.
  3. Participant has a body mass index (BMI) ≤18 or ≥45 kg/m^2 at Screening, which is subject to a broader evaluation of medical comorbidities.
  4. Participant has treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants within the current major depressive episode (excluding antipsychotics) from two different classes for at least 4 weeks of treatment.
  5. Participant has a medical history of seizures, bipolar disorder, schizophrenia, and/or schizoaffective disorder.
  6. Participant has a history of mild, moderate, or severe substance use disorder (including benzodiazepines) diagnosed using DSM-5 criteria in the 12 months prior to screening.
  7. Participant is taking psychostimulants (eg, methylphenidate, amphetamine) or opioids, regularly or as-needed, at Day -28.

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): NCT04442490


Locations
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United States, Arkansas
Sage Investigational Site
Rogers, Arkansas, United States, 72758
United States, California
Sage Investigational Site
Bellflower, California, United States, 90706
Sage Investigational Site
Garden Grove, California, United States, 92845
Sage Investigational Site
Glendale, California, United States, 91206
Sage Investigational Site
Lemon Grove, California, United States, 91945
Sage Investigational Site
Orange, California, United States, 92868
Sage Investigational Site
Pico Rivera, California, United States, 90660
Sage Investigational Site
Redlands, California, United States, 92374
Sage Investigational Site
San Diego, California, United States, 92103
Sage Investigational Site
Sherman Oaks, California, United States, 91403
Sage Investigational Site
Temecula, California, United States, 92591
United States, Florida
Sage Investigational Site
Coral Springs, Florida, United States, 33067
Sage Investigational Site
Hollywood, Florida, United States, 33024
Sage Investigational Site
Jacksonville, Florida, United States, 32256
Sage Investigational Site
Lauderhill, Florida, United States, 33319
Sage Investigational Site
Orange City, Florida, United States, 32763
Sage Investigational Site
Orlando, Florida, United States, 32801
Sage Investigational Site
Orlando, Florida, United States, 32807
United States, Georgia
Sage Investigational Site
Alpharetta, Georgia, United States, 30022
Sage Investigational Site
Atlanta, Georgia, United States, 30328
Sage Investigational Site
Atlanta, Georgia, United States, 30331
Sage Investigational Site
Decatur, Georgia, United States, 30030
United States, Illinois
Sage Investigational Site
Skokie, Illinois, United States, 60076
United States, Mississippi
Sage Investigational Site
Flowood, Mississippi, United States, 39232
United States, Missouri
Sage Investigational Site
O'Fallon, Missouri, United States, 63368
United States, Nevada
Sage Investigational Site
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Sage Investigational Site
Marlton, New Jersey, United States, 08053
United States, North Carolina
Sage Investigational Site
Charlotte, North Carolina, United States, 28211
United States, Ohio
Sage Investigational Site
Cincinnati, Ohio, United States, 45215
Sage Investigational Site
Dayton, Ohio, United States, 45417
Sage Investigational Site
North Canton, Ohio, United States, 44720
United States, Oklahoma
Sage Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Sage Investigational Site
Portland, Oregon, United States, 97210
United States, Pennsylvania
Sage Investigational Site
Allentown, Pennsylvania, United States, 18104
United States, Tennessee
Sage Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
Sage Investigational Site
DeSoto, Texas, United States, 75115
Sage Investigational Site
Wichita Falls, Texas, United States, 76309
United States, Virginia
Sage Investigational Site
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
Sage Therapeutics
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Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT04442490    
Other Study ID Numbers: 217-MDD-301B
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sage Therapeutics:
Depression
Depressive disorder
SAGE-217
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms