An Interventional, Open-label, Single Arm, Multicenter Study to Evaluate the Efficacy and Safety of Esketamine Nasal Spray in Korean Participants With Treatment-Resistant Depression(TRD)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 13
- 主要终点
- Change From Baseline to Day 28 in Hamilton Depression Rating Scale (HAM-D) Total Score
研究概览
简要总结
The purpose of this study is to evaluate how well esketamine nasal spray works in improving depressive symptoms in participants with treatment resistant depression (TRD). This will be assessed by the change from baseline in the Hamilton depression rating scale (HAM-D; 17-item) total score from Day 1 (baseline) to the end of the 4-week treatment phase (Day 28).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Must have a confirmed diagnosis of major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition at the time of enrollment, without psychotic features, based on clinical assessment, and confirmed by mini international neuropsychiatric interview (MINI)
- •Must have a Hamilton depression rating scale (HAM-D; 17-item) total score greater than or equal to (>=) 22 at screening and Day 1
- •Participants must have had non-response (less than or equal to [<=] 25 percent [%] improvement of symptoms) to >= 2 oral antidepressant treatments in the current moderate to severe episode of depression after having been given at an adequate dosage for an adequate duration of at least 6 weeks
- •At baseline (Day 1), the investigator will evaluate any changes in the participant's signs/symptoms of depression since the screening assessment and confirm that the inclusion criteria for the current antidepressant (AD) treatment are still met (that is, nonresponse and minimal clinical improvement)
- •A female participant of childbearing potential must have a negative serum pregnancy test at screening and urine prior to the first dose of study intervention on Day 1
排除标准
- •Participants with hyperthyroidism that has not been sufficiently treated
- •History of malignancy within 5 years of enrollment before screening
- •Known allergies, hypersensitivity, or intolerance to esketamine/ketamine or its excipients
- •Received an investigational intervention or used an invasive investigational medical device within 60 days before the planned first dose of study intervention or first data collection time point
- •Currently enrolled in an investigational study that involves treatments for MDD or may otherwise be expected to impact mood
研究组 & 干预措施
Esketamine Nasal Spray
Participants will self-administer one esketamine (flexibly dosed; 56 or 84 milligrams [mg]) nasal spray into each nostril (that is, a total of 2 sprays using 1 intranasal device) twice a week for 4 weeks. For 84 mg, sprays to each nostril will be delivered in rapid succession at 3 different time points (3 devices total). 56 mg will have 2 devices.
干预措施: Esketamine 56 mg (Drug)
Esketamine Nasal Spray
Participants will self-administer one esketamine (flexibly dosed; 56 or 84 milligrams [mg]) nasal spray into each nostril (that is, a total of 2 sprays using 1 intranasal device) twice a week for 4 weeks. For 84 mg, sprays to each nostril will be delivered in rapid succession at 3 different time points (3 devices total). 56 mg will have 2 devices.
干预措施: Esketamine 84 mg (Drug)
结局指标
主要结局
Change From Baseline to Day 28 in Hamilton Depression Rating Scale (HAM-D) Total Score
时间窗: Baseline up to Day 28
The HAM-D contains 17 items pertaining to symptoms of depression experienced over the past week. The questions cover core symptoms of depression as well as appetite and sleep (3 items). Items are scored on a likert scale of 0-4 or 0-2 depending on the item with a possible range of 0-52, with higher scores indicating greater severity of depressive symptoms.
Change From Baseline to Day 28 in Hamilton Depression Rating Scale (HAM-D) Total Score
时间窗: Baseline up to Day 28
The HAM-D contains 17 items pertaining to symptoms of depression experienced over the past week. The questions cover core symptoms of depression as well as appetite and sleep (3 items). Items are scored on a likert scale of 0-4 or 0-2 depending on the item with a possible range of 0-52, with higher scores indicating greater severity of depressive symptoms.
次要结局
- Change From Baseline Over Time for HAM-D Total Score(Baseline up to Week 4)
- Change From Baseline Over Time for Patient Health Questionnaire 9-item (PHQ-9) Total Score(Baseline up to Week 4)
- Percentage of Participants With Response Based on HAM-D Total Score Over Time(Up to Week 4)
- Percentage of Participants With Response Based on PHQ-9 Total Score Over Time(Up to Week 4)
- Percentage of Participants With Remission Based on HAM-D Total Score Over Time(Up to Week 4)
- Percentage of Participants With Remission Based on PHQ-9 Total Score Over Time(Up to Week 4)
- Percentage of Participants With Clinically Meaningful Improvement Based on HAM-D Total Score Over Time(Up to Week 4)
- Percentage of Participants With Clinically Meaningful Improvement Based on PHQ-9 Total Score Over Time(Up to Week 4)
- Change From Baseline Over Time for Clinical Global Impression-Severity (CGI-S) Score(Baseline up to Week 4)
- Change From Baseline Over Time for HAM-D Total Score(Baseline up to Week 4)
- Change From Baseline Over Time for Patient Health Questionnaire 9-item (PHQ-9) Total Score(Baseline up to Week 4)
- Percentage of Participants With Response Based on HAM-D Total Score Over Time(Up to Week 4)
- Percentage of Participants With Response Based on PHQ-9 Total Score Over Time(Up to Week 4)
- Percentage of Participants With Remission Based on HAM-D Total Score Over Time(Up to Week 4)
- Percentage of Participants With Remission Based on PHQ-9 Total Score Over Time(Up to Week 4)
- Percentage of Participants With Clinically Meaningful Improvement Based on HAM-D Total Score Over Time(Up to Week 4)
- Percentage of Participants With Clinically Meaningful Improvement Based on PHQ-9 Total Score Over Time(Up to Week 4)
- Change From Baseline Over Time for Clinical Global Impression-Severity (CGI-S) Score(Baseline up to Week 4)