临床试验/NCT00328822

NCT00328822已完成不适用

Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial

Khon Kaen University1 个研究点分布在 1 个国家目标入组 16 人开始时间: 2006年12月最近更新: 2008年3月18日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Khon Kaen University
入组人数: 16
试验地点: 1
主要终点: Total Sleep Time

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Primary insomnia patients will sleep with Quetiapine not better than without Quetiapine

详细描述

Primary insomnia will be diagnosed according to DSM-IV-TR
After consenting, cases will be divided (double blind randomization)in to two arms 2.1 sleep hygiene with placebo group 2.2 sleep hygiene with Quetiapine group
outcome measurement: sleep diary, sleep satisfaction visual analog scale and sleep satisfaction likert scale
statistical method: dependent T test

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

•Primary insomnia Patients by DSM-IV-TR criteria
•cases enrolled: age 18-65 educated

排除标准

•Currently receiving Quetiapine or other hypnotic drugs
•Liver disease
•Patients with heart Dz, Hypertension, thyroid disease
•History of epilepsy or febrile convulsion
•cognitive impairments
•History of Orthostatic Hypotension
•Patient with other Psychiatric conditions or Drug dependence

研究组 & 干预措施

A

Experimental

Quetiapine

干预措施: Quetiapine (Drug)

B

Placebo Comparator

Placebo

干预措施: placebo (Drug)

结局指标

主要结局

Total Sleep Time

时间窗: 3 weeks

次要结局

Sleep Latency Period, Sleep satisfaction(3 weeks)

研究者

发起方

Khon Kaen University

申办方类型

Other

研究点 (1)

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