A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of SAGE-217 in the Treatment of Adult Female Subjects With Severe Postpartum Depression
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 276
- 试验地点
- 2
- 主要终点
- Parts A and B: Change From Baseline in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15
研究概览
简要总结
The primary purpose of this study was to determine if treatment with SAGE-217 reduces depressive symptoms in participants with severe postpartum depression (PPD) compared to placebo as assessed by the change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score at Day 15 and to evaluate the safety and tolerability of SAGE-217 compared to placebo as assessed by the incidence of adverse events, vital sign measurements, clinical laboratory evaluations, electrocardiogram (ECG) parameters, and the Columbia Suicide Severity Rating Scale (C-SSRS).
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant either must have ceased lactating at screening or, if still lactating or actively breastfeeding at screening, must agree to temporarily cease giving breast milk to her infant(s)
- •Participant has had a Major Depressive Episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Axis I Disorders (SCID-I)
- •Participant was <=six months postpartum.
排除标准
- •Active psychosis
- •Attempted suicide associated with current episode of postpartum depression
- •Medical history of seizures
- •Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
- •Note: suicidal ideation was not an exclusion. Other protocol-defined inclusion/exclusion criteria might apply.
研究组 & 干预措施
Part A: SAGE-217 15/20 mg Oral Solution
Participants received SAGE-217, 15 milligrams (mg), oral solution, twice daily (BID) for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.
干预措施: SAGE-217 15/20 mg Oral Solution (Drug)
Part B: Placebo
Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.
干预措施: Placebo (Drug)
Part B: SAGE 217 30 mg Capsules
Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
干预措施: SAGE 217 30 mg Capsules (Drug)
结局指标
主要结局
Parts A and B: Change From Baseline in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15
时间窗: Parts A and B: Baseline, Day 15
The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. 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 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. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.
次要结局
- Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score(Part B: Baseline, Days 3, 8, 15, 21 and 45)
- Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response(Part B: Days 3, 8, 15, 21 and 45)
- Parts A and B: Percentage of Participants With MADRS Remission(Part B: Days 3, 8, 15, 21 and 45)
- Parts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(Part A: Up to Day 75; Part B: Up to Day 45)
- Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval(Part B: Baseline, Days 8, 15, and 21)
- Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45(Part B: Baseline, Days 3, 8, 21 and 45)
- Parts A and B: Percentage of Participants With HAM-D Response(Part B: Days 3, 8, 15, 21 and 45)
- Parts A and B: Percentage of Participants With HAM-D Remission(Part B: Days 3, 8, 15, 21 and 45)
- Parts A and B: Change From Baseline in HAM-D Individual Item Scores(Part B: Baseline, Days 3, 8, 15, 21 and 45)
- Parts A and B: Change From Baseline in HAM-D Subscales Scores(Part B: Baseline, Days 3, 8, 15, 21 and 45)
- Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score(Part B: Baseline, Days 3, 8, 15, 21 and 45)
- Parts A and B: Percentage of Participants With MADRS Response(Part B: Days 3, 8, 15, 21 and 45)
- Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements(Part B: From first dose of study drug up to 45 days)
- Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations(Part B: From first dose of study drug up to 45 days)
- Part B: Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate(Part B: Baseline, Days 8, 15, and 21)
- Part B: Number of Participants With a Response of "Yes" to Any Suicidal Ideation or Suicidal Behaviors Item Using the Columbia Suicide Severity Rating Scale (C-SSRS)(Part B: Up to Day 45)