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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 543
- 试验地点
- 1
- 主要终点
- Change From Baseline in the 17-item HAM-D Total Score at Day 15
研究概览
简要总结
The purpose of this study to evaluate the efficacy of SAGE-217 in the treatment of participants with MDD.
详细描述
This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
Participants self-administered SAGE-217 matched-placebo capsules, once daily at approximately 8 PM with fat-containing food for 14 days.
干预措施: Placebo (Drug)
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.
干预措施: SAGE-217 (Drug)
结局指标
主要结局
Change From Baseline in the 17-item HAM-D Total Score at Day 15
时间窗: 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.
次要结局
- 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)