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
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Depressive Disorder, Major
- Sponsor
- Biogen
- Enrollment
- 543
- Locations
- 1
- Primary Endpoint
- Change From Baseline in the 17-item HAM-D Total Score at Day 15
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study to evaluate the efficacy of SAGE-217 in the treatment of participants with MDD.
Detailed Description
This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •Participant has a Hamilton Rating Scale for Depression (HAM-D) total score ≥24 at screening and Day 1 (prior to dosing).
- •Participants taking antidepressants must have been taking these medications at the same dose for at least 60 days prior to Day
- •Participants who have stopped taking antidepressants within 60 days must have stopped for longer than 5 half-lives of the antidepressant prior to Day
- •Participants receiving psychotherapy must have been receiving therapy on a regular schedule for at least 60 days prior to Day
- •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
- •Participant is currently at significant risk of suicide, as judged by the Investigator, or has attempted suicide associated with the current episode of MDD.
- •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.
- •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.
- •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.
- •Participant has a medical history of seizures, bipolar disorder, schizophrenia, and/or schizoaffective disorder.
- •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.
- •Participant is taking psychostimulants (eg, methylphenidate, amphetamine) or opioids, regularly or as-needed, at Day -28.
Arms & Interventions
Placebo
Participants self-administered SAGE-217 matched-placebo capsules, once daily at approximately 8 PM with fat-containing food for 14 days.
Intervention: Placebo
SAGE-217 50 mg
Participants self-administered SAGE-217 50 mg capsules, once daily at approximately 8 PM with fat-containing food for 14 days. Participants who could not tolerate 50 mg received 40 mg for the remainder of the treatment period as per discretion of investigator.
Intervention: SAGE-217
Outcomes
Primary Outcomes
Change From Baseline in the 17-item HAM-D Total Score at Day 15
Time Frame: Baseline, 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 HAM-D score is the sum of individual items, ranging from 0 to 52; where a higher score indicates more depression. A negative change indicates improvement. A mixed Model for Repeated Measures (MMRM)was used for the analysis.
Secondary Outcomes
- Change From Baseline in MADRS Total Score at Day 15(Baseline, Day 15)
- Change From Baseline in the HAM-D Total Score at Days 3, 8 and 42(Baseline, Days 3, 8, and 42)
- Change From Baseline in HAM-A Total Score at Day 15(Baseline, Day 15)
- Percentage of Participants Achieving HAM-D Response(Days 15 and 42)
- Percentage of Participants Achieving HAM-D Remission(Days 15 and 42)
- Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response at Day 15(Day 15)
- Change From Baseline in Patient- Reported Outcome (PRO) Measures of Health-Related Quality of Life, as Assessed by the 36-item Short Form Version 2 (SF-36v2) Score at Days 8, 15, 28 and 42(Baseline, Days 8, 15, 28 and 42)
- Change From Baseline in PRO Measures of Depressive Symptoms, as Assessed by the 9-item Patient Health Questionnaire (PHQ-9) Total Score at Days 8, 15, 28 and 42(Baseline, Days 8, 15, 28 and 42)
- Change From Baseline in the CGI-S Score at Day 15(Baseline, Day 15)
- Time to First HAM-D Response(Up to Day 57)