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
- 581
- 试验地点
- 2
- 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
This study is a phase 3, multicenter, double-blind, randomized, placebo-controlled study evaluating the efficacy of SAGE-217 in the treatment of adult participants with major depressive disorder (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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant had a diagnosis of MDD with symptoms that had been present for at least a 4-week period.
- •Participant had a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥32 and a 17-item Hamilton Rating Scale for Depression (HAM-D) total score ≥22 at screening and Day 1 (prior to dosing).
排除标准
- •Participant had active psychosis.
- •Participant had attempted suicide associated with the current episode of MDD.
- •Participant had a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
研究组 & 干预措施
SAGE-217 Matched Placebo
Participants self-administered SAGE-217 matched placebo capsules, orally, once daily in the evening with food for 14 days.
干预措施: Placebo (Drug)
SAGE-217 20 mg
Participants self-administered SAGE-217 20 milligrams (mg) capsules, orally, once daily in the evening with food for 14 days.
干预措施: SAGE-217 (Drug)
SAGE-217 30 mg
Participants self-administered SAGE-217 30 mg capsules, orally, once daily in the evening with food for 14 days.
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 (BL), Day 15
The 17-item HAM-D is used to rate the severity of depression in participants who were already diagnosed as depressed. The HAM-D total score comprises a sum of the 17 individual item scores. 8 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 9 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. Total HAM-D score can range from 0 to 52, and higher scores indicate severe depression. A negative change from baseline indicates less depression.
次要结局
- Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Day 15(Baseline, Day 15)
- Change From Baseline in the 17-item HAM-D Total Score(Baseline, Days 3, 8, 42, and 182)
- Number of Participants Achieving HAM-D Response(Days 15, 42, and 182)
- Number of Participants Achieving HAM-D Remission(Days 15, 42, and 182)
- Number of Participants Achieving Clinical Global Impression - Improvement (CGI-I) Response at Day 15(Day 15)
- Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Day 15(Baseline, Day 15)
- Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 15(Baseline, Day 15)
- Change From Baseline in HAM-D Core Subscale Score(Baseline, Days 15, and 42)
- Change From Baseline in HAM-D Anxiety Subscale Score(Baseline, Days 15, and 42)
- Change From Baseline in HAM-D Bech-6 Subscale Score(Baseline, Days 15, and 42)
- Change From Baseline in HAM-D Maier Subscale Score(Baseline, Days 15, and 42)
- Change From Baseline in HAM-D Individual Item Scores(Baseline, Days 15, and 42)
- Change From Baseline in Insomnia Severity Index (ISI) Total Score(Baseline, Days 15, and 42)
- Change From Baseline in Core Consensus Sleep Diary Parameters: Sleep Onset Latency (sSL), Wake After Sleep Onset (sWASO), and Total Sleep Time (sTST)(Baseline, Days 15, and 28)
- Change From Baseline in Core Consensus Sleep Diary Parameter: Number of Awakenings (sNAW)(Baseline, Days 15, and 28)
- Change From Baseline in Core Consensus Sleep Diary Parameter: Number of Participants With Subjective Sleep Quality (sSQ) Response(Baseline, Days 15, and 28)
- Change From Baseline in the 36-item Short Form Survey Version 2 (SF-36v2) Physical and Mental Component Summary Scores(Baseline, Days 15, and 42)
- Change From Baseline in the 9-item Patient Health Questionnaire (PHQ-9) Total Score(Baseline, Days 15, and 42)
- Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) and Serious TEAE in Treatment and FU Periods(Treatment period: Up to Day 14; FU period: Day 15 to 42)
- Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) and Serious TEAE in Extended FU Period(Extended FU Period: Day 43 to 182)
- Number of Participants With Clinically Significant Abnormalities in Laboratory Measures in Treatment and FU Periods(Treatment period: Up to Day 14; FU period: Day 15 to 42)
- Number of Participants With Clinically Significant Vital Sign Abnormalities in Treatment and FU Periods(Treatment period: Up to Day 14; FU period: Day 15 to 42)
- Number of Participants With Clinically Significant Vital Sign Abnormalities in Extended FU Period(Extended FU Period: Day 43 to 182)
- Number of Participants With Clinically Significant Abnormalities in Laboratory Measures in Extended FU Period(Extended FU Period: Day 43 to 182)
- Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities in Treatment and FU Periods(Treatment period: Up to Day 14; FU period: Day 15 to 42)
- Number of Participants With Suicidal Ideation or Behavior Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) in Extended FU Period at Day 182(Day 182)
- Number of Participants With Clinically Significant ECG Abnormalities in Extended FU Period(Extended FU Period: Day 43 to 182)
- Number of Participants With Suicidal Ideation or Behavior Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) in Double-blind Treatment Period at Day 42(Day 42)
- Change From Baseline in the 20-item Physician Withdrawal Checklist (PWC-20) Total Score(Baseline, Days 15, 18, and 21)