Effect of Olanzapine on Sleep Electroencephalogram (EEG) in Schizophrenia Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Sleep EEG
研究概览
简要总结
Acute and sub-chronic administration of olanzapine has shown a favourable effect on the sleep disturbances in previously medicated schizophrenia patients with predominantly negative symptoms. The present study will be carried out to clarify the effect of olanzapine on polysomnographic profiles of schizophrenia patients in an acute phase of illness after controlling for the drug effects.
详细描述
Twenty schizophrenia patients (11 drug naïve and 9 drug free) will be studied over a period of six weeks of olanzapine treatment. Patients will be assessed at the baseline on BPRS, PANSS, CDSS and UKU side effect rating scales and a baseline 40 channels polysomnography will be done. After the initial assessment, patients will put on olanzapine treatment, in flexible dosages based on clinical response, for a period of six weeks when a final assessment on clinical rating scales and polysomnography will be done. The sleep data will be scored manually for staging based on Rechtschaffen and Kales criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients fulfilling International Classification of Diseases-10 Diagnostic Criteria for Research for schizophrenia
- •Aged 18-50 Yrs
- •Drug naïve or drug free (not receiving any psychotropic medication for the past 4 months)
排除标准
- •Any comorbid psychiatric illness
- •Significant medical or neurological illness
- •History of significant head injury, epilepsy
- •Substance use in the past 4 months excluding nicotine and caffeine
- •Presence of a primary sleep disorder
研究组 & 干预措施
Schizophrenia patients
The study population of 25 schizophrenia patients constituted the active arm of the study.
干预措施: Olanzapine (Drug)
结局指标
主要结局
Sleep EEG
时间窗: 06 weeks
Changes in Sleep EEG parameters like Total sleep time, total sleep period, sleep efficiency, sleep latency, stage shifts, stage 1 shifts, stage 1 parameters, stage 2 parameters, stage 3 parameters, stage 4 parameters, rapid eye movement (REM) parameters.
次要结局
- Psychopathology(06 weeks)