Objective:The purpose of the present study was to evaluate the efficacy and safety of (−)-OSU6162 in doses up to 30 mg b.i.d. in patients suffering from mental fatigue following stroke or traumatic brain injury (TBI).Methods:This 4 + 4 weeks double-blind randomised cross-over study included 30 patients afflicted with mental fatigue following a stroke or head trauma occurring at least 12 months earlier. Efficacy was assessed using the Mental Fatigue Scale (MFS), the Self-rating Scale for Affective Syndromes [Comprehensive Psychopathological Rating Scale (CPRS)], the Frenchay Activity Index (FAI), and a battery of neuropsychological tests. Safety was evaluated by recording spontaneously reported adverse events (AEs).Results:There were significant differences on the patients’ total FAI scores (p = 0.0097), the subscale FAI outdoor scores (p = 0.0243), and on the trail making test (TMT-B) (p = 0.0325) in favour of (−)-OSU6162 treatment. Principal component analysis showed a clear overall positive treatment effect in 10 of 28 patients; those who responded best to treatment had their greatest improvements on the MFS. Reported AEs were mild or moderate in severity and did not differ between the (−)-OSU6162 and the placebo period.Conclusion:The most obvious beneficial effects of (−)-OSU6162 were on the patients’ activity level, illustrated by the improvement on the FAI scale. Moreover, a subgroup of patients showed substantial improvements on the MFS. Based on these observed therapeutic effects, in conjunction with the good tolerability of (−)-OSU6162, this compound may offer promise for treating at least part of the symptomatology in patients suffering from stroke- or TBI-induced mental fatigue.

中文翻译：

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单胺能稳定剂 (−)-OSU6162 对中风或创伤性脑损伤后精神疲劳的影响

目的：本研究的目的是评估 (−)-OSU6162 在中风或创伤性脑损伤 (TBI) 后精神疲劳患者中的疗效和安全性，剂量高达 30 mg bid。方法：这 4 + 4周双盲随机交叉研究包括至少 12 个月前发生中风或头部外伤后遭受精神疲劳的 30 名患者。使用精神疲劳量表 (MFS)、情感综合征自我评定量表 [综合精神病理学评定量表 (CPRS)]、Frenchay 活动指数 (FAI) 和一系列神经心理学测试来评估疗效。通过记录自发报告的不良事件（AE）来评估安全性。结果：患者的总 FAI 评分存在显着差异（p= 0.0097)，子量表 FAI 户外得分 (p= 0.0243)，并在试行测试 (TMT-B) (p= 0.0325) 有利于 (−)-OSU6162 处理。主成分分析显示，28 名患者中有 10 名患者有明显的总体积极治疗效果；那些对治疗反应最好的人在 MFS 上的改善最大。报告的 AE 严重程度为轻度或中度，在 (-)-OSU6162 和安慰剂期之间没有差异。结论：(-)-OSU6162 最明显的有益作用是对患者的活动水平，通过改善固定资产投资规模。此外，一部分患者的 MFS 有显着改善。基于这些观察到的治疗效果，再加上 (-)-OSU6162 的良好耐受性，该化合物可能有望治疗中风或 TBI 诱发的精神疲劳患者的至少部分症状。