Interventional, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Initial Administration of 25 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
- 80
- 试验地点
- 13
- 主要终点
- Change from baseline (Day 0) to Day 1 (24 h post-infusion) in MADRS-6 subscale score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of vortioxetine given as a single intravenous dose of 25 mg at initiation of an oral vortioxetine regimen of 10 mg/day for 7 days
详细描述
The study consists of a 7-day double-blind Treatment Period (Day 0 to Day 6)
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 MDD, diagnosed according to DSM-5® and confirmed using the Mini-International Neuropsychiatric Interview (MINI).
- •The patient has a MADRS total score ≥ 30 at the Screening Visit.
- •As part of standard of care treatment, the patient is to be admitted to hospital due to the severity of the depressive symptoms and is willing to remain hospitalized for the duration of the study treatment period.
- •The patient has had the current MDE for ≥3 months but less than 12 months.
- •The patient has received treatment for the current episode with an SSRI/SNRI monotherapy (citalopram, escitalopram, paroxetine, duloxetine, venlafaxine, sertraline) at an approved dose for at least 6 weeks.
- •Exclusion criteria:
- •The patient has any current psychiatric disorder or Axis I disorder (DSM-5® criteria), established as the primary diagnosis, other than MDD, as assessed using the MINI or another diagnostic interview
- •Other in- and exclusion criteria may apply
排除标准
- 未提供
研究组 & 干预措施
Vortioxetine
干预措施: Vortioxetine infusion 25 mg (Drug)
Vortioxetine
干预措施: Vortioxetine tablets 10 mg/day (Drug)
Placebo
干预措施: Placebo infusion (Drug)
Placebo
干预措施: Placebo tablets (Drug)
结局指标
主要结局
Change from baseline (Day 0) to Day 1 (24 h post-infusion) in MADRS-6 subscale score
时间窗: From baseline (Day 0) to Day 1 (24 h post-infusion)
The Montgomery and Åsberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60. The primary endpoint will be evaluated with MADRS-6 subscale score, calculated based on the scores on MADRS items 1, 2, 3, 7, 8, and 9 which cover core symptoms (apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts) and is more sensitive to the effect of treatment.
次要结局
- Change from baseline (Day 0) to Day 3 in MADRS-6 subscale score(From baseline (Day 0) to Day 3)
- CGI-I score at Day 1, Day 3, Day 7(At Day 1, Day 3, Day 7)
- Change in MADRS total score from baseline to Day 1, Day 3, Day 7(From baseline to Day 1, Day 3, Day 7)
- CGI-I response (defined as CGI-I score ≤2) on Day 1 and 3(At Day 1 and 3)
- CL/F of vortioxetine(Day 0, Day 1, Day 7)
- Change from baseline (Day 0) to Day 7 in MADRS-6 subscale score(From baseline (Day 0) to Day 7)
- Cav(Day 0, Day 1, Day 7)
- ≥50% decrease in MADRS total score from baseline on Day 1 and Day 3(On Day 1 and Day 3)
- Change from baseline in CGI-S score to Day 1, Day 3, Day 7(From baseline to Day 1, Day 3, Day 7)