NCT00259311已完成2 期
A Randomized, Double-Blind Comparison of 5 mg of LY2422347, 15 mg of LY2422347, and Placebo in the Treatment of Patients With Primary Insomnia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 22
- 主要终点
- The primary efficacy measure will be Wakening After Sleep Onset (WASO)
研究概览
简要总结
The purpose of this study is to determine whether a compound known as LY2422347 is effective in treating people diagnosed with primary insomnia (difficulty sleeping with no other significant contributing factor, such as depression).
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
入排标准
- 年龄范围
- 24 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •must have been diagnosed with primary insomnia
- •must not be significantly overweight
- •must be able to visit the study doctor's office once every 2 weeks for 8 weeks and willing to use a handheld electronic device as a sleep diary every day
- •must be able to read and speak in English and be able to see well enough to use the handheld electronic device
- •the patient's answer to the question "During the past month, how would you rate your sleep quality overall?" must be either "Very Bad" or "Fairly Bad"
排除标准
- •cannot have a clinically significant and/or uncontrolled condition or other significant ailment including restless leg syndrome (RLS) or periodic limb movement disorder (PLMD)
- •cannot have obstructive sleep apnea (OSA), or be considered by the study doctor to have probable OSA based upon patient history and physical examination
- •cannot be currently using antidepressants, antipsychotics, stimulants, antihistaminics, or other medications that are known to effect sleep
- •cannot have a current or previous major psychiatric disorder (other than insomnia) such as depression, schizophrenia, bipolar disorder, social anxiety, or another psychotic disorder.
结局指标
主要结局
The primary efficacy measure will be Wakening After Sleep Onset (WASO)
次要结局
- Wake Time During Sleep (WTDS) and Wake Time After Sleep (WTAS)
- improvement of daily subjective sleep quality at endpoint
- reduction in the Number of Awakenings or Arousal Index and increase of time spent in Slow Wave Sleep (SWS) and various other parameters at endpoint as measured with PSG
- Various characteristics of sleep and daytime functioning assessed with biweekly self-report questionnaires at endpoint
- increase in subjective sleep efficiency at endpoint as assessed by the patient's daily diary
- Clinician Global Impression of Improvement (CGI-I) score at endpoint
- improvement at endpoint on the biweekly subjective assessment of physical role functioning, emotional role functioning, vitality, social functioning, and mental health using the Short Form-12
- Safety and tolerability of LY2422347 compared with placebo
研究者
研究点 (22)
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