NCT02918318已完成2 期
A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Doses of Intranasal Esketamine in Japanese Subjects With Treatment Resistant Depression
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 202
- 主要终点
- Double-Blind (DB) Induction Phase: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of fixed dosed intranasal esketamine compared to intranasal placebo, as an add-on to an oral antidepressant in Japanese participants with treatment-resistant depression (TRD), in improving depressive symptoms.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At the start of the screening phase, participant must meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) or recurrent major depressive disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the Mini International Neuropsychiatric Interview (MINI). In the case of single-episode MDD, the participant must be diagnosed with persistent depressive disorder, which meets criteria of major depressive episode for a continuous duration of greater than or equal to (>=)2 years, and the same physician from the site must be examining the participant for >=2 years continuously as a primary care physician of the participant
- •The participant's current major depressive episode, depression symptom severity (MADRS total score greater than or equal to [>=] 28 required), and antidepressant treatment response in the current depressive episode, must be confirmed using the SAFER interview
- •Participant must be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs (including blood pressure), pulse oximetry, and 12-lead electrocardiogram (ECG) performed in the screening phase
- •A woman of childbearing potential must have a negative highly sensitive serum Beta (β) human chorionic gonadotropin [β-hCG] test at the start of the screening phase and a negative urine pregnancy test must be obtained before the first dose of study drug on Day 1 of the double-blind induction phase prior to randomization
- •Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
排除标准
- •Participant has received vagal nerve stimulation or has received deep brain stimulation in the current episode of depression
- •Participant previously received esketamine or ketamine as treatment for their MDD
- •Participant has homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 6 months prior to the start of the screening phase
- •Participant has a history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria, except nicotine or caffeine, within 6 months before the start of the screening phase
- •Participant has a current or past history of seizure disorder (uncomplicated childhood febrile seizures with no sequelae are not exclusionary)
研究组 & 干预措施
Placebo
Experimental
Participant will receive 1 spray of placebo to each nostril at 0 minute, 5 minutes and 10 minutes.
干预措施: Placebo (Drug)
Esketamine 28 milligram (mg)
Experimental
Participant will receive 1 spray of Esketamine to each nostril at 0 minute and placebo at 5 minutes and 10 minutes.
干预措施: Intranasal esketamine (28 mg) (Drug)
Esketamine 56 mg
Experimental
Participant will receive 1 spray of Esketamine to each nostril at 0 minute, 5 minutes and placebo at 10 minutes.
干预措施: Intranasal esketamine (56 mg) (Drug)
Esketamine 84 mg
Experimental
Participant will receive 1 spray of Esketamine to each nostril at 0 minute, 5 minutes and 10 minutes.
干预措施: Intranasal esketamine (84 mg) (Drug)
结局指标
主要结局
Double-Blind (DB) Induction Phase: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28
时间窗: Baseline (Day 1) up to Day 28 (DB phase) induction
MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. Negative change in score indicates improvement.
次要结局
- DB Induction Phase: Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Day 28(Baseline (Day 1) to Day 28 (DB induction phase))
- DB Induction Phase: Percentage of Participants With Response Based on MADRS Total Score(Days 2, 8, 15, 22 and 28 (DB induction phase))
- DB Induction Phase: Percentage of Participants Showing Onset of Clinical Response(Day 2 up to Day 28 (DB induction phase))
- DB Induction Phase: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score up to Day 28(Baseline (Day 1) up to Day 28 (DB induction pahse))
- DB Induction Phase: Change From Baseline in Generalized Anxiety Disorder 7-Item Scale (GAD-7) up to Day 28(Baseline (Day 1) up to Day 28 (DB induction phase))
- OL Induction Phase: Percentage of Participants With Severity of Psychopathology on the CGI-S Scale(Baseline (Prior to first dose of OL induction phase on Day 1), endpoint of OL induction phase (last post baseline assessment value during the OL induction phase [OL: up to Day 28]))
- Posttreatment Phase: Time to Relapse in Participants With Remission (MADRS Total Score <=12)(From EndPoint (last post baseline assessment value during the DB induction phase [up to Day 28]) up to 24 weeks (posttreatment phase))
- Posttreatment Phase: Time to Relapse in Participants With Response (>=50% Reduction From Baseline in MADRS Total Score) But Who Are Not in Remission(From EndPoint (last post baseline assessment value during the DB induction phase [up to Day 28]) up to 24 weeks (posttreatment phase))
- Posttreatment Phase: Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Weeks 2, 4, 6, 8, 12, 16, 20 and 24(Baseline (DB induction phase), Weeks 2, 4, 6, 8, 12, 16, 20 and 24 (posttreatment phase))
- OL Induction Phase: Percentage of Participants With Remission Based on MADRS Total Score(Days 8, 15, 22 and 28 (OL induction phase))
- OL Induction Phase: Change From Baseline (Prior to the First Dose of OL Induction Phase) in MADRS Total Score up to Endpoint OL Induction Phase (Last Post Baseline Assessment Value During the OL Induction Phase [OL: up to Day 28])(Baseline (Prior to first Dose of OL induction phase on Day 1) up to endpoint of OL induction phase (last post baseline assessment value during OL induction phase [OL: up to Day 28]))
- DB Induction Phase: Percentage of Participants With Remission Based on MADRS Total Score(Days 2, 8, 15, 22 and 28 (DB induction phase))
研究者
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