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

Published online by Cambridge University Press:  07 December 2017

Marie Karin Lena Nilsson Open the ORCID record for Marie Karin Lena Nilsson [Opens in a new window] ,
Olof Zachrisson ,
Carl-Gerhard Gottfries ,
Michael Matousek ,
Birgitta Peilot ,
Sara Forsmark ,
Robert Christiaan Schuit ,
Maria Lizzie Carlsson ,
Angelica Kloberg  and
Arvid Carlsson
Marie Karin Lena Nilsson*
Affiliation:
Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
Olof Zachrisson
Affiliation:
Gottfries Clinic, affiliated with Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
Carl-Gerhard Gottfries
Affiliation:
Gottfries Clinic, affiliated with Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
Michael Matousek
Affiliation:
Gottfries Clinic, affiliated with Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
Birgitta Peilot
Affiliation:
Gottfries Clinic, affiliated with Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
Sara Forsmark
Affiliation:
Gottfries Clinic, affiliated with Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
Robert Christiaan Schuit
Affiliation:
Department of Radiology and Nuclear Medicine, VU University Medical Centre, Amsterdam, The Netherlands
Maria Lizzie Carlsson
Affiliation:
Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden Gottfries Clinic, affiliated with Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
Angelica Kloberg
Affiliation:
A Carlsson Research AB, Sahlgrenska Science Park, Gothenburg, Sweden
Arvid Carlsson
Affiliation:
Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
*
Marie KL Nilsson, Institute of Neuroscience and Phyisology, The Sahlgrenska Academy at University of Gothenburg/ Sahlgrenska Science Park, Medicinaregatan 8 A, 413 90 Gothenburg, Sweden. Tel: +46 31 741 1795; E-mail: [email protected]
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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

(−)-OSU6162fatiguemonoaminergic stabilisermyalgic encephalomyelitis
Type
Original Article
Information
Acta Neuropsychiatrica , Volume 30 , Issue 3 , June 2018 , pp. 148 - 157
Copyright
© Scandinavian College of Neuropsychopharmacology 2017 

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