NL-OMON31525已完成3 期
A randomized long-term safety study of Org 50081 in elderly outpatients with chronic primary insomnia examining the effects of 1.5 mg or 3.0 mg of Org 50081 - JADE
Organon Nederland BV0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •At least 65 years of age at screening.;Have documented diagnosis of chronic primary insomnia with a duration of >_ 1 month.;Are able to speak, read and understand the language of the investigator, study
- •staff (including raters) and the informed consent form, and possess the ability to
- •respond to questions, follow instructions and complete questionnaires.;Have demonstrated capability to independently complete the LogPad
- •questionnaires in the week preceding randomization;
排除标准
- •have other sleep disorders;have any significant medical or psychiatric illness causing sleepdisturbances;have any significant medical or DSM-IV-TR psychiatric illness causing the sleep
- •disturbances;;currently meet diagnostic criteria for DSM-IV-TR depression (MDD) or have been
- •diagnosed and treated for MDD within the last 2 years;;have signs of dementia or other serious cognitive impairment, defined by a score
- •of less than 26 on the Mini-Mental State Examination (MMSE);;have a history of bipolar disorder, a history of suicide attempt or a family history
- •of suicide;
研究者
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