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

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.

• Authors: Marie Karin Lena Nilsson, Olof Zachrisson, Carl-Gerhard Gottfries, Michael Matousek, Birgitta Peilot, Sara Forsmark, Robert Christiaan Schuit, Maria Lizzie Carlsson, Angelica Kloberg, Arvid Carlsson
• Journal: Acta neuropsychiatrica (Acta Neuropsychiatr) Vol. 30 Issue 3 Pg. 148-157 (Jun 2018) ISSN: 1601-5215 [Electronic] England
• PMID: 29212562 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Antidepressive Agents
• Dopamine Agents
• Piperidines
• OSU 6162

Topics

• Adult
• Antidepressive Agents (pharmacology)
• Combined Modality Therapy
• Depression (drug therapy, physiopathology)
• Dopamine Agents (administration & dosage, pharmacology)
• Dose-Response Relationship, Drug
• Fatigue Syndrome, Chronic (drug therapy, physiopathology)
• Female
• Follow-Up Studies
• Humans
• Male
• Mental Fatigue (drug therapy, physiopathology)
• Middle Aged
• Outcome Assessment, Health Care (methods)
• Piperidines (administration & dosage, pharmacology)