A Phase 3, Randomized, Double-Blind Study Comparing the Efficacy and Safety of SAGE-217 Plus an Antidepressant Versus Placebo Plus an Antidepressant in Adults 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
- 440
- 试验地点
- 1
- 主要终点
- Change From Baseline in the HAMD-17 Total Score at Day 3
研究概览
简要总结
The primary purpose of this study is to evaluate the efficacy of SAGE-217 plus an ADT in the treatment of major depressive disorder (MDD) compared to placebo plus an ADT.
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
- •Diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Clinical Trials Version (SCID-5-CT), with symptoms that have been present for at least a 4-week period
- •17-item Hamilton Rating Scale for Depression (HAM-D-17) total score of ≥24 at Screening and Day 1
- •Participant in good physical health and has no clinically significant findings, as determined by the investigator, on physical examination, 12-lead electrocardiogram (ECG), or clinical laboratory tests
- •Participant is willing, able, and eligible to take at least 1 of the 5 ADTs specified in the protocol (an eligible ADT is an ADT that has not been taken during the current depressive episode and for which the participant has no contraindications; further, a participant is not eligible for citalopram if escitalopram has been taken during the current depressive episode, and vice versa)
排除标准
- •Has attempted suicide associated with the current episode of MDD
- •Participant had 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 treatment-resistant depression
- •History of bipolar disorder, schizophrenia, and/or schizoaffective disorder
- •Known allergy to SAGE-217, allopregnanolone, or related compounds
- •Has taken antidepressants within 30 days prior to Day 1, and/or has taken fluoxetine within 60 days prior to Day 1
研究组 & 干预措施
Placebo + Assigned ADT
Participants received SAGE-217-matching placebo capsules, orally, once daily along with an assigned ADT (sertraline, escitalopram, citalopram, duloxetine, or desvenlafaxine administered per labeled prescribing information), daily, from Day 1 through 14, followed by the same ADT, per labeled prescribing information, daily, up to Day 42.
干预措施: Matching Placebo (Drug)
Placebo + Assigned ADT
Participants received SAGE-217-matching placebo capsules, orally, once daily along with an assigned ADT (sertraline, escitalopram, citalopram, duloxetine, or desvenlafaxine administered per labeled prescribing information), daily, from Day 1 through 14, followed by the same ADT, per labeled prescribing information, daily, up to Day 42.
干预措施: Sertraline (Drug)
Placebo + Assigned ADT
Participants received SAGE-217-matching placebo capsules, orally, once daily along with an assigned ADT (sertraline, escitalopram, citalopram, duloxetine, or desvenlafaxine administered per labeled prescribing information), daily, from Day 1 through 14, followed by the same ADT, per labeled prescribing information, daily, up to Day 42.
干预措施: Escitalopram (Drug)
Placebo + Assigned ADT
Participants received SAGE-217-matching placebo capsules, orally, once daily along with an assigned ADT (sertraline, escitalopram, citalopram, duloxetine, or desvenlafaxine administered per labeled prescribing information), daily, from Day 1 through 14, followed by the same ADT, per labeled prescribing information, daily, up to Day 42.
干预措施: Citalopram (Drug)
Placebo + Assigned ADT
Participants received SAGE-217-matching placebo capsules, orally, once daily along with an assigned ADT (sertraline, escitalopram, citalopram, duloxetine, or desvenlafaxine administered per labeled prescribing information), daily, from Day 1 through 14, followed by the same ADT, per labeled prescribing information, daily, up to Day 42.
干预措施: Duloxetine (Drug)
Placebo + Assigned ADT
Participants received SAGE-217-matching placebo capsules, orally, once daily along with an assigned ADT (sertraline, escitalopram, citalopram, duloxetine, or desvenlafaxine administered per labeled prescribing information), daily, from Day 1 through 14, followed by the same ADT, per labeled prescribing information, daily, up to Day 42.
干预措施: Desvenlafaxine (Drug)
SAGE-217 + Assigned ADT
Participants received SAGE-217, 50 milligrams (mg), orally, once daily along with an assigned ADT (sertraline, escitalopram, citalopram, duloxetine, or desvenlafaxine administered per labeled prescribing information), daily from Day 1 through 14, followed by the same ADT, per labeled prescribing information, daily, up to Day 42.
干预措施: SAGE-217 (Drug)
SAGE-217 + Assigned ADT
Participants received SAGE-217, 50 milligrams (mg), orally, once daily along with an assigned ADT (sertraline, escitalopram, citalopram, duloxetine, or desvenlafaxine administered per labeled prescribing information), daily from Day 1 through 14, followed by the same ADT, per labeled prescribing information, daily, up to Day 42.
干预措施: Sertraline (Drug)
SAGE-217 + Assigned ADT
Participants received SAGE-217, 50 milligrams (mg), orally, once daily along with an assigned ADT (sertraline, escitalopram, citalopram, duloxetine, or desvenlafaxine administered per labeled prescribing information), daily from Day 1 through 14, followed by the same ADT, per labeled prescribing information, daily, up to Day 42.
干预措施: Escitalopram (Drug)
SAGE-217 + Assigned ADT
Participants received SAGE-217, 50 milligrams (mg), orally, once daily along with an assigned ADT (sertraline, escitalopram, citalopram, duloxetine, or desvenlafaxine administered per labeled prescribing information), daily from Day 1 through 14, followed by the same ADT, per labeled prescribing information, daily, up to Day 42.
干预措施: Citalopram (Drug)
SAGE-217 + Assigned ADT
Participants received SAGE-217, 50 milligrams (mg), orally, once daily along with an assigned ADT (sertraline, escitalopram, citalopram, duloxetine, or desvenlafaxine administered per labeled prescribing information), daily from Day 1 through 14, followed by the same ADT, per labeled prescribing information, daily, up to Day 42.
干预措施: Duloxetine (Drug)
SAGE-217 + Assigned ADT
Participants received SAGE-217, 50 milligrams (mg), orally, once daily along with an assigned ADT (sertraline, escitalopram, citalopram, duloxetine, or desvenlafaxine administered per labeled prescribing information), daily from Day 1 through 14, followed by the same ADT, per labeled prescribing information, daily, up to Day 42.
干预措施: Desvenlafaxine (Drug)
结局指标
主要结局
Change From Baseline in the HAMD-17 Total Score at Day 3
时间窗: Baseline, Day 3
The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to 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 3-point (0=none to 2=severe) or 5-point scale (0=none/absent to 4=most severe). Total score is the sum of individual items, ranging from 0 (not depressed) to 52 (severely depressed); where a higher score indicates more depression. A negative change from baseline indicated improvement. Least Squares (LS) mean was estimated using mixed effects model for repeated measures (MMRM) analysis.
次要结局
- Change From Baseline in the HAMD-17 Total Score Over the Double-Blind Treatment Period(Baseline through Day 15)
- Change From Baseline in the HAMD-17 Total Score at Days 15 and 42(Baseline, Days 15 and 42)
- Percentage of Participants With MADRS Remission at Day 15(Day 15)
- Percentage of Participants With CGI-I Response, at Day 3 and Day 15(Days 3 and 15)
- Change From Baseline in the HAMD-17 Total Score Around End of Blinded Treatment(Baseline, End of blinded treatment assessment (i.e., average of Days 12, 15 , and 18))
- Percentage of Participants With HAMD-17 Response at Day 15 and Day 42(At Days 15 and 42)
- Percentage of Participants With HAMD-17 Remission at Day 15 and Day 42(Days 15 and 42)
- Percentage of Participants With MADRS Response at Day 15(Day 15)
- Change From Baseline in HAM-A Total Score at Day 15(Baseline, Day 15)
- Change From Baseline in CGI-S Score at Day 15(Baseline and Day 15)
- Change From Baseline in MADRS Total Score at Day 15(Baseline and Day 15)
- Time to First HAMD-17 Response(From first dose of study drug up to first HAMD-17 response (up to approximately 65 days))
- Change From Baseline in Depressive Symptoms at Day 15, as Assessed by PHQ-9(Baseline and Day 15)
- Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)(Up to approximately 58 weeks)
- Percentage of Participants With TEAEs, Graded by Severity(Up to approximately 58 weeks)