A Six-Week Double-Blind Randomized, Placebo-Controlled, Parallel Group, Efficacy and Safety, Sleep Lab 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
- 419
- 主要终点
- Average Wake Time After Sleep Onset (WASO) During the In-Treatment Period
研究概览
简要总结
The purpose of this trial is to investigate the efficacy, safety and tolerability of esmirtazapine (Org 50081) compared to placebo in patients with chronic primary insomnia.
详细描述
Insomnia is a common complaint or disorder throughout the world. About one third of the population in the industrial countries reports difficulty initiating or maintaining sleep, resulting in a non-refreshing or non-restorative sleep. The majority of the insomniacs suffer chronically from their complaints. It has been reported that in patients with chronic insomnia lasting longer than six months, 50% had a past or current mental disorder. This raises the possibility that treatment of insomnia may reduce the risk for psychological conditions. This double-blind, placebo-controlled, parallel, randomized clinical trial is designed to assess the efficacy and safety of esmirtazapine in patients suffering from chronic primary insomnia.
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
- •Documented diagnosis of chronic primary insomnia
排除标准
- •Other sleep disorder such as sleep apnea, restless leg syndrome, narcolepsy, sleep/wake rhythm disorders
- •Has significant medical or psychiatric illness as causing the sleep disorder
- •Diagnosed with major depressive disorder
- •Substance abuse within the past year
- •Night worker or work on rotating shifts
- •Has had serious head injury, stroke, epilepsy
- •Has a history of bipolar disorder or family (immediate family) history of suicide
- •Smokes more than 15 cigarettes per day and cannot abstain from smoking during the night or in the sleep laboratory
- •Drinks beverages containing more than 500 mg caffeine per day
研究组 & 干预措施
Esmirtazapine 3.0 mg
Participants took placebo tablets on Days -7 and -6, esmirtazapine 3.0 mg tablets on Days 1-42, and placebo tablets on Days 43-50. Tablets were taken by mouth once daily in the evening.
干预措施: Esmirtazapine (Drug)
Esmirtazapine 4.5 mg
Participants took placebo tablets on Days -7 and -6, esmirtazapine 4.5 mg tablets on Days 1-42, and placebo tablets on Days 43-50. Tablets were taken by mouth once daily in the evening.
干预措施: Esmirtazapine (Drug)
Placebo
Participants took placebo tablets on Days -7 and -6, placebo tablets on Days 1-42, and placebo tablets on Days 43-50. Tablets were taken by mouth once daily in the evening.
干预措施: Placebo (Drug)
结局指标
主要结局
Average Wake Time After Sleep Onset (WASO) During the In-Treatment Period
时间窗: From Day 1 to Day 36
WASO was defined as the total objective time awake after the onset of persistent sleep until the end of the 8-hour sleep cycle period as measured by polysomnography (PSG). WASO was calculated as the mean of Nights 1, 15, and 36.
次要结局
- Average Latency to Persistent Sleep (LPS) During the In-Treatment Period(From Day 1 to Day 36)
- Average Subjective Total Sleep Time (TST) During the In-Treatment Period(From Day 1 to Day 36)