A Two-Week, Double Blind, Placebo-Controlled, Randomized, Parallel Group, Efficacy and Safety Out-Patient Trial With Org 50081 in Patients With Chronic Primary Insomnia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 526
- 主要终点
- Average Total Sleep Time (TST) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period
研究概览
简要总结
The purpose of this study is to determine if esmirtazapine (Org 50081) is a safe and effective treatment for insomnia. It was anticipated that esmirtazapine would increase mean Total Sleep Time (TST) as recorded in sleep diaries relative to placebo.
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
- •Has signed written informed consent after the scope and nature of the investigation was explained to them
- •Has difficulty falling asleep, maintaining sleep or has early morning awakenings
排除标准
- •Significant medical or psychiatric illness causing sleep disturbances
- •Has a history of bipolar disorder or family (immediate family) of suicide
- •Has sleep disorder such as sleep related breathing disorder, restless leg syndrome, narcolepsy
- •Has significant other medical illness such as acute or chronic pain, heart, kidney or liver disease within the last year
- •Currently diagnosed or meets the criteria for Major Depressive Disorder (MDD) or has been treated for MDD with the last 2 years
- •Substance abuse, excessive use of alcohol (as determined by the physician) or drug addiction within the last year.
研究组 & 干预措施
Esmirtazapine 1.5 mg
Esmirtazapine 1.5 mg tablet, oral administration in the evening, once daily, for 2 weeks
干预措施: Esmirtazapine (Drug)
Esmirtazapine 3.0 mg
Esmirtazapine 3.0 mg tablet, oral administration in the evening, once daily, for 2 weeks
干预措施: Esmirtazapine (Drug)
Esmirtazapine 4.5 mg
Esmirtazapine 4.5 mg tablet, oral administration in the evening, once daily, for 2 weeks
干预措施: Esmirtazapine (Drug)
Placebo
Placebo to esmirtazapine
干预措施: Placebo (Drug)
结局指标
主要结局
Average Total Sleep Time (TST) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period
时间窗: Day 1 to Day 15
TST was defined as the total amount of time (measured in minutes) that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. TST values over the 14-day active treatment period were averaged for each participant, and average TST was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were present was used in the analysis.
次要结局
- Average Sleep Latency (SL) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period(Day 1 to Day 15)
- Number of Participants Experiencing an Adverse Event (AE) During the 14-day In-treatment Period(Day 1 to Day 15)
- Number of Participants Who Discontinued From Study Treatment Due to an AE During the 14-day In-Treatment Period(Day 1 to Day 15)