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Tolerability and efficacy of the monoaminergic stabilizer (-)-OSU6162 (PNU-96391A) in Huntington's disease: A double-blind cross-over study

Journal article
Authors A. Kloberg
Radu Constantinescu
Marie Nilsson
Maria L. Carlsson
Arvid Carlsson
Jan Wahlström
Sara Haghighi
Published in Acta Neuropsychiatrica
Volume 26
Issue 5
Pages 298-306
ISSN 0924-2708
Publisher Cambridge University Press
Publication year 2014
Published at Institute of Biomedicine, Department of Medical and Clinical Genetics
Institute of Neuroscience and Physiology
Institute of Neuroscience and Physiology, Department of Clinical Neuroscience and Rehabilitation
Pages 298-306
Language en
Links dx.doi.org/10.1017/neu.2014.16
Keywords depression, huntington's disease, monoaminergic stabilizer, vitality, 3 [3 (methylsulfonyl)phenyl] 1 propylpiperidine, absence of side effects, adult, Article, Beck Depression Inventory, clinical article, cognition, controlled study, crossover procedure, double blind procedure, drug efficacy, drug tolerability, female, human, Huntington chorea, male, mental function, mood, motor performance, quality of life, randomized controlled trial, rating scale, Short Form 36, social status, symptomatology
Subject categories Clinical Medicine

Abstract

Objective To evaluate the safety (primary objective) and efficacy (secondary objective) of (-)-OSU6162 in Huntington's disease (HD). Methods In a double-blind, cross-over trial, patients with HD were randomly assigned to start treatment on either (-)-OSU6162 or placebo. After 4 weeks, those patients who initially received active drug were switched to placebo for another 4 weeks, and vice versa. During the first week the (-)-OSU6162 dose was 15 mg twice daily, during the second week 30 mg twice daily, and during the last 2 weeks 45 mg twice daily. Motor, cognitive, mental and social functions were rated by the clinical investigator or by self-assessment, using established rating scales. Results Fifteen patients fulfilling inclusion and exclusion criteria completed the study. (-)-OSU6162 was well tolerated by all patients and no adverse effects were observed. (-)-OSU6162 treatment significantly improved the Short Form 36 Vitality score, mainly due to an improvement of the individual item 'worn-out' (VT3). In addition, an improvement of depressive symptoms was found using Beck Depression Inventory. In contrast to a general trend of improvement in several non-motor variables only small and non-significant differences between (-)-OSU6162 and placebo were found regarding motor functions. Conclusions (-)-OSU6162 offers promise for the treatment of HD, as a drug with good tolerability, capable of improving the patients' experienced non-motor functions such as energy and mood and thus alleviating symptoms of great importance for their quality of life. © © Scandinavian College of Neuropsychopharmacology 2014.

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