NCT01660880已完成不适用
Validation of Receptor Occupancy Simulation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Dopamine receptor occupancy
研究概览
简要总结
- To estimate dopamine receptor occupancy by aripiprazole using computer simulation
- To measure dopamine receptor occupancy by aripiprazole in patients treated with the antipsychotics
- To validate the simulation result by comparing the receptor occupancy from the simulation with that from the patients
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of schizophrenia
- •treated with aripiprazole or risperidone
- •no change in dose of antipsychotics for at least 6 weeks
- •total PANSS score should be below 80
排除标准
- •Other psychiatric disorders rather than schizophrenia
- •history of head trauma
- •positive in urine hCG
- •on antidepressant, anticholinergics or mood stabilizer
结局指标
主要结局
Dopamine receptor occupancy
时间窗: 72 hrs after the last administration
Measured using 11C-raclopride positron emission tomography
次要结局
- Hamilton rating scale for depression(Baseline and 72 hours after the last administration)
- Barnes akathisia scale(Baseline and 72 hours after the last administration)
- Abnormal involuntary movement scale(Baseline and 72 hours after the last administration)
- Simpson-Angus scale(Baseline and 72 hours after the last administration)
- Treatment satisfaction questionnaire for medication(Baseline and 72 hours after the last administration)
- Medication satisfaction questionnaire(Baseline and 72 hours after the last administration)
- N-back task(Baseline and 72 hours after the last administration)
- Prolactin level(Baseline and 72 hours after the last administration)
- Dopamine receptor occupancy(24 hrs after the last administration)
研究者
Jun Soo Kwon
Professor
Seoul National University Hospital
研究点 (1)
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