A Phase 3, Randomized, Double-Blind, Placebo-controlled Study of the Efficacy and Safety of SAGE-217 With a Fixed, Repeated Treatment Regimen on Relapse Prevention in Adults With Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Biogen
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Time to Relapse During the DB Phase
研究概览
简要总结
This is a study with an Open-Label (OL) phase followed by a randomized, Double-Blind (DB), placebo-controlled phase to assess efficacy and safety of SAGE-217 on relapse prevention in adults 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
- Sequential
- 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 as diagnosed by Structured Clinical Interview for Diagnostic and DSM-5 Clinical Trial Version (SCID-5-CT), with symptoms that had been present for at least a 4-week period.
- •Participant had at least 1 prior major depressive episode (MDE) in the 5 years prior to Screening (not including the current episode).
- •Participant was willing to delay the start of any antidepressant, anxiolytic, insomnia, psychostimulant, prescription opioid regimens, and new psychotherapy (including Cognitive Behavioral Therapy for Insomnia [CBT-I]) until after study completion.
排除标准
- •Participant had attempted suicide associated with the current episode of MDD.
- •Participant had 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. Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ) was used for this purpose.
- •Participant had a positive pregnancy test at screening or on Day 1 prior to dosing.
研究组 & 干预措施
Open-Label Phase: SAGE-217
Participants self-administered SAGE-217, 30 milligrams (mg), oral capsule, once daily (QD) in the evening from Day 1 to Day 14.
干预措施: SAGE-217 (Drug)
Double-Blind Phase: Placebo
Following the OL Phase, participants who exhibited a Hamilton Rating Scale for Depression (HAM-D) response, defined as a greater than or equal to (≥) 50% reduction from baseline in HAM-D total score were to be randomized to receive SAGE-217 matching placebo capsule, orally, QD, in the evening, in a total of five, 14-day treatment periods, each separated by a 6-week follow-up period during the 40-week DB Phase of the study. However, no participants were randomized to receive SAGE-217 matching placebo due to early study termination.
干预措施: Placebo (Drug)
Double-Blind Phase: SAGE-217
Following the OL Phase, participants who exhibited a HAM-D response defined as a ≥ 50% reduction from baseline in HAM-D total score to SAGE-217 were randomized to receive SAGE-217, 30 mg, oral capsule, QD, in the evening, up to study termination date (i.e., up to approximately 22 weeks) during the DB Phase of the study.
干预措施: SAGE-217 (Drug)
结局指标
主要结局
Time to Relapse During the DB Phase
时间窗: Day 56 (Day 1 of DB Phase) up to Day 153 (i.e., up to 22 weeks)
Time to relapse was defined as days from the first dose of the study drug in the DB Phase to the day of relapse during the DB Phase. Participant was considered to have relapsed if: 2 consecutive HAM-D scores were ≥ 18 assessed 7 to 14 days apart, any worsening of depression requiring hospitalization, Investigator-determined risk of suicide, or any other clinically relevant event whether or not hospitalization was required. HAM-D is a scale used to rate depression in participants who were already diagnosed as depressed. The HAM-D total score comprised a sum of 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia, somatic symptoms, genital symptoms, loss of weight, and insight. Items scored in a range of 0 to 4 included: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety, hypochondriasis. The HAM-D total score could range from 0 (not depressed) to 52 (severely depressed). Higher scores indicated more depression.
次要结局
- Percentage of Participants With HAM-D Response at the End of Each 14-Day Treatment Period in the DB Phase(Day 56 (Day 1 of DB Phase) up to Day 153 (i.e., up to 22 weeks))
- Percentage of Participants With HAM-D Remission at the End of Each 14-Day Treatment Period in the DB Phase(Day 56 (Day 1 of DB Phase) up to Day 153 (i.e., up to 22 weeks))
- Percentage of Participants Who Relapsed During the DB Phase(Day 56 (Day 1 of DB Phase) up to Day 153 (i.e., up to 22 weeks))
- Change From Baseline in the 17-Item HAM-D Total Score at the End of Each 14-Day Treatment Period in the DB Phase(Day 56 (Baseline [Day 1] of DB Phase) up to Day 153 (i.e., up to 22 weeks))
- Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response at the End of Each 14-Day Treatment Period in the DB Phase(Day 56 (Day 1 of DB Phase) up to Day 153 (i.e., up to 22 weeks))
- Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at the End of Each 14-Day Treatment Period in the DB Phase(Day 56 (Baseline [Day 1] of DB Phase) up to Day 153 (i.e., up to 22 weeks))
- Change From Baseline in 9-Item Patient Health Questionnaire (PHQ-9) Score at the End of Each 14-Day Treatment Period in the DB Phase(Day 56 (Baseline [Day 1] of DB Phase) up to Day 153 (i.e, up to 22 weeks))
- Time to Relapse During The DB Phase for Participants Who Achieved HAM-D Remission in the OL Phase(Day 56 (Day 1 of DB Phase) up to Day 153 (i.e., up to 22 weeks))
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(From the first dose of study drug up to the end of the study (i.e., up to approximately 22 weeks))