Stille G, Herberg K W
Fortschr Med. 1989 Jan 20;107(2):75-8.
Forty-eight healthy volunteers aged between 18 and 61 years, 24 men, 24 women, received dosulepin (Idom) or placebo in a randomized fashion over a period of 16 days. The study was designed as a double-blind, placebo controlled parallel trial. The single daily dose of 75 mg was given in the evening. In order to assess driving ability under medication, the following parameters were examined before the study and on days 3, 10 and 17: visual orientation, concentration stress toleration while performing reaction tasks, eye-hand coordination, vigilance, accuracy and speed of reaction, and sense of wellbeing. Apart from a mild loss of concentration and decrease in the sense of wellbeing, none of the other parameters showed any significant changes as compared with placebo. The results are in good agreement with those of earlier relevant trials with other antidepressants. The results of the present study form the basis for an assessment of the driving ability of the individual patient receiving dosulepin.
48名年龄在18至61岁之间的健康志愿者,其中男性24名,女性24名,在16天的时间里随机接受了多塞平(Idom)或安慰剂治疗。该研究设计为双盲、安慰剂对照平行试验。每日单次剂量75毫克于晚上服用。为了评估服药状态下的驾驶能力,在研究前以及第3天、第10天和第17天对以下参数进行了检查:视觉定向、执行反应任务时的注意力集中程度、耐压力能力、眼手协调能力、警觉性、反应准确性和速度以及幸福感。除了轻微的注意力不集中和幸福感下降外,与安慰剂相比,其他参数均未显示出任何显著变化。这些结果与早期使用其他抗抑郁药进行的相关试验结果高度一致。本研究结果为评估接受多塞平治疗的个体患者的驾驶能力奠定了基础。