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Effect of the monoaminergic stabiliser (−)-OSU6162 on mental fatigue following stroke or traumatic brain injury

Published online by Cambridge University Press:  18 May 2020

Marie K.L. Nilsson Open the ORCID record for Marie K.L. Nilsson [Opens in a new window] ,
Birgitta Johansson ,
Maria L. Carlsson ,
Robert C. Schuit  and
Lars Rönnbäck
Marie K.L. Nilsson*
Affiliation:
Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
Birgitta Johansson
Affiliation:
Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
Maria L. Carlsson
Affiliation:
Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
Robert C. Schuit
Affiliation:
Department of Radiology and Nuclear Medicine, Amsterdam UMC, location VUmc, Amsterdam, The Netherlands
Lars Rönnbäck
Affiliation:
Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
*
Author for correspondence: Marie K.L. Nilsson, Email: [email protected]
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Abstract

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.

Keywords

drug therapybrain injuriesstrokemental fatiguelife quality
Type
Original Article
Information
Acta Neuropsychiatrica , Volume 32 , Issue 6 , December 2020 , pp. 303 - 312
Copyright
© Scandinavian College of Neuropsychopharmacology 2020

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Footnotes

In memory of Nobel Prize Winner Arvid Carlsson and senior doctor Elisabeth Nordquist Brandt, MD. Arvid Carlsson devoted his last 10 years almost entirely to the further exploration and development of (−)-OSU6162, which included this and other clinical studies as well as preclinical research. Elisabeth Nordquist Brandt was deeply engaged in the clinical development of (−)-OSU6162; in the present study, she was responsible for the clinical aspects involving the stroke patients.

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