A randomised controlled trial of the monoaminergic stabiliser (-)-OSU6162 in treatment of myalgic encephalomyelitis/chronic fatigue syndrome
| Autor: | Michael Matousek, Sara Forsmark, Olof Zachrisson, Angélica Kloberg, Robert C. Schuit, Marie Nilsson, Carl-Gerhard Gottfries, Maria L. Carlsson, Birgitta Peilot, Arvid Carlsson |
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| Přispěvatelé: | Radiology and nuclear medicine |
| Rok vydání: | 2017 |
| Předmět: |
Adult
Male medicine.medical_specialty Dopamine Agents Placebo law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Piperidines law Internal medicine Outcome Assessment Health Care medicine Chronic fatigue syndrome Humans Stroke Biological Psychiatry Depression (differential diagnoses) Fatigue Syndrome Chronic Dose-Response Relationship Drug business.industry Depression Beck Depression Inventory Middle Aged medicine.disease Mental Fatigue Combined Modality Therapy Antidepressive Agents 030227 psychiatry Psychiatry and Mental health Concomitant Clinical Global Impression Female business 030217 neurology & neurosurgery Follow-Up Studies |
| Zdroj: | Acta Neuropsychiatrica, 148-157. Cambridge University Press STARTPAGE=148;ENDPAGE=157;ISSN=0924-2708;TITLE=Acta Neuropsychiatrica Nilsson, M K L, Zachrisson, O, Gottfries, C G, Matousek, M, Peilot, B, Forsmark, S, Schuit, R C, Carlsson, M L, Kloberg, A & Carlsson, A 2018, ' A randomised controlled trial of the monoaminergic stabiliser (−)-OSU6162 in treatment of myalgic encephalomyelitis/chronic fatigue syndrome ', Acta Neuropsychiatrica, pp. 148-157 . https://doi.org/10.1017/neu.2017.35 |
| ISSN: | 1601-5215 0924-2708 |
| DOI: | 10.1017/neu.2017.35 |
| Popis: | ObjectiveThe 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.MethodsA 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.ResultsMFS 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. |
| Databáze: | OpenAIRE |
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