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Acta Neuropsychiatr. 2018 Jun;30(3):148-157. doi: 10.1017/neu.2017.35. Epub 2017 Dec 7.

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

Author information

1
1Department of Clinical Neuroscience,Institute of Neuroscience and Physiology,Sahlgrenska Academy,University of Gothenburg,Gothenburg,Sweden.
2
2Gottfries Clinic, affiliated with Institute of Neuroscience and Physiology,Sahlgrenska Academy,University of Gothenburg,Gothenburg,Sweden.
3
3Department of Radiology and Nuclear Medicine,VU University Medical Centre,Amsterdam,The Netherlands.
4
4A Carlsson Research AB,Sahlgrenska Science Park,Gothenburg,Sweden.

Abstract

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 µM. 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.

KEYWORDS:

(−)-OSU6162; fatigue; monoaminergic stabiliser; myalgic encephalomyelitis

PMID:
29212562
DOI:
10.1017/neu.2017.35
[Indexed for MEDLINE]

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