A Randomized, Double-Blind, Placebo-controlled Study Evaluating the Efficacy and Safety of SAGE-217 in the Treatment of Adults 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
- 200
- 试验地点
- 3
- 主要终点
- Change From Baseline (CFB) 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 purpose of this study is to determine if treatment with SAGE-217 reduces depressive symptoms in females with severe postpartum depression (PPD) as compared to placebo.
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 has ceased lactating or agrees not to provide breastmilk to her infant(s) from just prior to receiving the investigational product (IP) on Day 1 until 7 days after the last dose of IP.
- •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 Structured Clinical Interview for Diagnostic and DSM-5 Clinical Trial Version (SCID-5-CT).
- •Participant is ≤12 months postpartum at screening and Day 1.
排除标准
- •Participant is at significant risk of suicide or has attempted suicide associated with the current episode of PPD.
- •Participant has active psychosis per investigator assessment.
- •Participant has a medical history of nonfebrile seizures.
- •Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
- •Participant has a history of sleep apnea.
- •Note: Other protocol-defined inclusion/exclusion criteria applied.
研究组 & 干预措施
Placebo
Participants received SAGE-217 matched-placebo capsules, orally, once daily for 14 days.
干预措施: Placebo (Drug)
SAGE-217 50 mg
Participants received SAGE-217, 50 mg, capsules, orally, once daily for 14 days.
干预措施: SAGE-217 (Drug)
结局指标
主要结局
Change From Baseline (CFB) in the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15
时间窗: Baseline and Day 15
The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of 17 individual items related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), work and activities (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), retardation, agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), 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 the 17 individual items, ranges from 0 to 52; where a higher score indicates more depression. Negative change from baseline indicates improvement. Mixed Model for Repeated Measures (MMRM) was used for the analysis.
次要结局
- Change From Baseline in the 17-item HAM-D Total Score(Baseline, Days 3, 28 and 45)
- Percentage of Participants With HAM-D Response(Days 15 and 45)
- Percentage of Participants With HAM-D Remission(Days 15 and 45)
- Change From Baseline in Clinical Global Impressions - Severity Scale (CGI-S) Score(Baseline and Day 15)
- Change From Baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) Total Score(Baseline and Day 15)
- Change From Baseline in HAM-D Subscale(Baseline and Day 15)
- Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response(Day 15)
- Change From Baseline in Hamilton Rating Scale for Anxiety (HAM-A) Total Score(Baseline and Day 15)
- Change From Baseline in Self-Reported Measures of Depressive Symptoms, as Assessed by the Edinburgh Postnatal Depression Scale (EPDS) Total Score(Baseline, Days 3, 8,15, 21, 28 and 45)
- Change From Baseline in Self-Reported Measures of Depressive Symptoms, as Assessed by the 9-item Patient Health Questionnaire (PHQ-9) Score(Baseline, Days 3, 8,15, 21, 28 and 45)
- Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)(Up to Day 45)