Assessment of Bupropion on Cognitive Function and Behaviour in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Cognitive and executive functions after the first dose and the 14-day treatment.Subjective feelings after the first dose and the 14-day treatment : ARCI, Norris and POMS scales.
研究概览
简要总结
To evaluate the effects of a 14-day repeated dose of 150 mg bupropion (therapeutic dose) on cognitive and executive functions, behaviour and subjective feelings, after sleep deprivation in 12 healthy male subjects.
详细描述
The aim of this controlled double-blind randomized 3-session cross-over designed study is to evaluate the effects of a single dose of 150 mg and a 14-day repeated dose of 300 mg bupropion (therapeutic dose) on cognitive and executive functions, behaviour and subjective feelings, and some physical parameters after sleep deprivation in 12 trained healthy volunteers (18-35 years old).
Cognitive and executive functions were assessed by reaction times, critical flicker fusion test, Stroop test, digit symbol substitution test, span test and short term recal of pictures, tapping and tracking tests.
Behaviour and subjective effects explored were :
- feelings frequently experienced with psychotropic drugs assessed by ARCI,
- some mood states as tension, depression, anger, vigor, fatigue and confusion assessed by both POMS and Norris visual analogic scales,
- sleep assessed by LSEQ,
- feeding behaviour assessed by food intake during a meal test and self-ratings of appetite and satiety,
Physical parameters were :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI between 20.0 and 25.00
- •no smoker
排除标准
- 未提供
结局指标
主要结局
Cognitive and executive functions after the first dose and the 14-day treatment.Subjective feelings after the first dose and the 14-day treatment : ARCI, Norris and POMS scales.
次要结局
- Sleep questionnaire after the 14-day treatment. Energy intake after the 14-day treatment. Blood pressure after one dose and the 14-day treatment