Interventional, Randomised, Double-blind, Parallel-group Study of the Efficacy and Safety of Initial Administration of 17 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 7
- 主要终点
- Change from baseline to Week 1 in MADRS total score
研究概览
简要总结
To evaluate the early onset of efficacy of vortioxetine 17 mg intravenously (IV) and vortioxetine 10 mg/day oral dose regimen versus placebo IV and vortioxetine 10 mg/day oral dose regimen on 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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has recurrent Major Depressive Disorder (MDD), diagnosed according to Diagnostic and Statistical Manual for Mental Disorders, 5th Edition (DSM-5™), classification code (296.3x). The recurrent Major Depressive Episode (MDE) should be confirmed using the Mini-International Neuropsychiatric Interview (MINI).
- •The patient has a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥30 at both Screening and Baseline Visits.
- •The patient has had the current MDE for ≥3 months
排除标准
- •The patient has any current psychiatric disorder or Axis I disorder (DSM-5™ criteria), other than MDD, as assessed using the Mini International Neuropsychiatric Interview (MINI).
- •The patient has a current diagnosis of history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features (DSM-5™ criteria).
- •The patient suffers from personality disorders, intellectual disability, pervasive development disorder, attention deficit/hyperactivity disorder, organic mental disorders, or mental disorders due to a general medical condition (DSM-5™ criteria).
- •The patient has a history of lack of response to previous treatment with vortioxetine (including current episode).
- •Other Protocol defined inclusion and exclusion criteria may apply
研究组 & 干预措施
IV vortioxetine
干预措施: Vortioxetine (IV) (Drug)
IV vortioxetine
干预措施: Vortioxetine (tablet) (Drug)
IV placebo
干预措施: Placebo (IV) (Other)
IV placebo
干预措施: Vortioxetine (tablet) (Drug)
结局指标
主要结局
Change from baseline to Week 1 in MADRS total score
时间窗: Baseline to Week 1
The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
次要结局
- Change from baseline to Week 2 in MADRS total score(Baseline to Week 2)
- Change from baseline to Day 3 in MADRS total score(Baseline to Day 3)
- Change from baseline to Day 1 in MADRS total score(Baseline to Day 1)
- Response (defined as a ≥ 50% decrease in MADRS total score from baseline) at Week 1(Week 1)
- Remission at Week 1 (defined as a MADRS total score ≤ 10)(Week 1)
- Change from baseline to Week 1 in HADS depression subscale(baseline to Week 1)
- Global clinical impression -Global Improvement(At Week 1)
- Change from baseline in Global clinical impression -Severity(Baseline to Week 1)
- Oral clearance (CL/F)(2, 8 and 24 hours postdose (day 1) and day 14)
- Average Plasma Concentration (Cav)(2, 8 and 24 hours postdose (day 1) and day 14)
- Change from baseline to Week 1 in HADS anxiety subscale(Baseline to Week 1)