NCT00951418已完成不适用
Serum Clozapine and Cognition
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Cognitive function measured by CANTAB
研究概览
简要总结
This study aim to investigate the relationship between serum levels of clozapine and cognitive performance in patients with ICD-10 Schizophrenia and treated with clozapine monotherapy. The hypothesis is that higher serum levels of clozapine are associated with cognitive dysfunctions. Furthermore, ECG changes and the relation to serum level of clozapine are studied. The design is cross-sectional.
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
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
- •Treated with clozapine for minimum 6 months.
- •Fixed dosage of clozapine last month before inclusion.
排除标准
- •Substance misuse.
- •Depression (Calgary Depression score ≥7).
- •Somatic disease that interfere with cognitive performance.
- •Treatment with benzodiazepines (half-lives >15 hours not allowed up 14 days prior inclusion and during study. Half-lives < 15 hours not allowed 3 days prior cognitive testing).
- •Electroconvulsive therapy.
- •Treatment with other antipsychotics.
- •Withdrawal of informed consent.
- •Compulsory measures.
- •Treatment with anticholinergics except for atropine drops administered sublingually.
- •Changes in use of tobacco last month before inclusion.
结局指标
主要结局
Cognitive function measured by CANTAB
时间窗: once
次要结局
- T-wave morphology(Once)
- Sedation VAS,ACES and SWAI scale(once)
研究者
研究点 (1)
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