A Randomised, Double-blind, Parallel-group, Placebo-controlled, and Active-referenced Study Evaluating the Efficacy and Safety of Three Fixed Dose Regimens of Lu AA34893 in the Treatment of Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Depressive symptoms as measured by the change from baseline in MADRS total score
研究概览
简要总结
The purpose of the study is to evaluate the efficacy, safety and tolerability of three fixed dosages of Lu AA34893 compared to placebo in the treatment of patients with Major Depressive Disorder.
详细描述
Major Depressive Disorder (MDD) is reported to be the most common mood disorder, with a lifetime prevalence of about 15% and as high as 25% in women. MDD is characterised by the presence of one or more Major Depressive Episodes (MDEs) that presents with depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and poor concentration. MDD is a disabling, severe illness that tends to be chronic, and repeated episodes are common. Despite the availability of a range of effective treatments in MDD, a significant proportion of patients do not respond or achieve remission and many relapse despite continued treatment. Lu AA34893 has a novel mechanism of action and this could be of clinical relevance in addressing currently unmet needs in MDD.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major Depressive Episode (MDE) as primary diagnosis according to DSM-IV (classification code 296.xx)
- •Moderate to severe depression
- •Current MDE duration of at least 3 months
排除标准
- •Any current psychiatric disorder other than MDD as defined in the DSM-IV TR
- •Any substance disorder within the previous 6 months
- •Females of childbearing potential and not using adequate contraception
- •Use of any psychoactive medication within 2 weeks before randomisation and during the study
研究组 & 干预措施
1
干预措施: Lu AA34893 (Drug)
2
干预措施: Lu AA34893 (Drug)
3
干预措施: Lu AA34893 (Drug)
4
干预措施: Venlafaxine extended release (Drug)
5
干预措施: Placebo (Drug)
结局指标
主要结局
Depressive symptoms as measured by the change from baseline in MADRS total score
时间窗: 8 weeks
次要结局
- HAM-D, CGI, responders and remitters, HAM-A, adverse events, clinical safety laboratory tests, vital signs, weight, ECG, physical examination(8 weeks)