A randomised controlled trial of the monoaminergic stabiliser (-)-OSU6162 in treatment of myalgic encephalomyelitis/chronic fatigue syndrome

被引:12
|
作者
Nilsson, Marie Karin Lena [1 ]
Zachrisson, Olof [2 ]
Gottfries, Carl-Gerhard [2 ]
Matousek, Michael [2 ]
Peilot, Birgitta [2 ]
Forsmark, Sara [2 ]
Schuit, Robert Christiaan [3 ]
Carlsson, Maria Lizzie [1 ,2 ]
Kloberg, Angelica [4 ]
Carlsson, Arvid [1 ]
机构
[1] Univ Gothenburg, Dept Clin Neurosci, Inst Neurosci & Physiol, Sahlgrenska Acad, Gothenburg, Sweden
[2] Univ Gothenburg, Gottfries Clin, Inst Neurosci & Physiol, Sahlgrenska Acad, Gothenburg, Sweden
[3] Vrije Univ Amsterdam, Dept Radiol & Nucl Med, Med Ctr, Amsterdam, Netherlands
[4] Carlsson Res AB, Sahlgrenska Sci Pk, Gothenburg, Sweden
来源
ACTA NEUROPSYCHIATRICA | 2018年 / 30卷 / 03期
关键词
(-)-OSU6162; fatigue; monoaminergic stabiliser; myalgic encephalomyelitis; SEROTONIN REUPTAKE INHIBITORS; 5-HT2A SEROTONIN; MENTAL FATIGUE; CROSS-OVER; PLACEBO; RECEPTORS; ANTIDEPRESSANTS; (+)-OSU6162; SYMPTOMS; DISEASE;
D O I
10.1017/neu.2017.35
中图分类号
Q189 [神经科学];
学科分类号
071006 ;
摘要
Objective: The monoaminergic stabiliser (-)-OSU6162 has in previous studies shown promising effects on mental fatigue after stroke and traumatic brain injury. This study investigated the safety and effectiveness of (-)-OSU6162 in patients with myalgic encephalomyelitis/chronic fatigue syndrome. Methods: A total of 62 patients were randomly assigned to placebo or (-)-OSU6162. Primary outcomes were assessment on the mental fatigue scale (MFS) and the clinical global impression of change (CGI-C) scale. Secondary outcomes were results on the FibroFatigue scale (FF), the Beck Depression Inventory (BDI), the pain visual analogue scale and neuropsychological tests. Assessments were performed at baseline, after 1 and 2 weeks of treatment and at follow-up after 6 weeks. Results: MFS and CGI-C showed significant improvements for both treatment groups after treatment but not at follow-up; a similar pattern was seen for FF and BDI. However, significant differences between groups could not be demonstrated. On the other hand, correlation analyses showed a significant correlation between (-)-OSU6162 concentration and change in MFS, FF, and BDI score within the concentration interval 0.1-0.7 mu M. Exploratory subgroup analyses showed a larger treatment effect with (-)-OSU6162 in improving MFS and FF symptoms in patients on antidepressant therapy compared to those without antidepressant treatment. Conclusion: (-)-OSU6162 was found to be safe and well tolerated. When analysing the entire material (-)-OSU6162 was not found to differ significantly from placebo in alleviating fatigue in ME patients but was superior to placebo in counteracting fatigue in a subgroup of ME patients who received concomitant pharmacological treatment for depression.
引用
收藏
页码:148 / 157
页数:10
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