1. Efficacy of patient education and duloxetine, alone and in combination, for patients with multisystem functional somatic disorder: Study protocol for the EDULOX trial.
- Author
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Jespersen CP, Pedersen HF, Kleinstäuber M, Fink P, Wellnitz KB, Ørnbøl E, Schröder A, Agger JL, Vase L, Finnerup NB, and Gormsen LK
- Subjects
- Adult, Female, Humans, Male, Middle Aged, Antidepressive Agents therapeutic use, Antidepressive Agents administration & dosage, Anxiety drug therapy, Combined Modality Therapy, Quality of Life, Randomized Controlled Trials as Topic, Depression drug therapy, Duloxetine Hydrochloride therapeutic use, Duloxetine Hydrochloride administration & dosage, Patient Education as Topic methods
- Abstract
Background: Multisystem functional somatic disorder is characterized by specific patterns of persistent physical symptoms with a complex biopsychosocial etiology. The disorder can lead to disability and personal suffering. Current treatment options require specialized settings, therefore patients often wait a long time to receive specific treatment. Patient education is considered important in most treatment programs, but has only been investigated sparsely as a stand-alone treatment. Pharmacological treatment is limited to tricyclic antidepressants in low doses with no antidepressant properties. Duloxetine has been found effective in single organ functional disorders. As a treatment for multisystem functional somatic disorder, duloxetine could reduce symptoms and treat comorbid anxiety and depression. It may furthermore enhance the effect of patient education through a hypothesized effect on cognitive functioning. The purpose of the EDULOX trial is to study psycho-EDUcation and duLOXetine alone and in combination., Methods: This is a nested study design. The parent trial "EDULOX1" (n = 424) will compare a patient education program with enhanced usual care in an open-labelled, randomized controlled trial. In addition to this, eligible participants will furthermore receive either duloxetine or active placebo in the nested, double-blinded, randomized controlled trial, "EDULOX2" (n = 212). Patient and clinician reported outcomes will be collected through questionnaires., Conclusion: The EDULOX trial may establish evidence for treatments applicable for the majority of patients with multisystem functional somatic disorder. If effective, duloxetine would be a more tolerable pharmacological treatment option that can target comorbid depression and anxiety, and potentially boost the effect of patient education. Trial registration number The study is registered at www., Clinicaltrials: gov (NCT06232473) and the internal list of research projects at the Region of Central Denmark (Case number 1-16-02-305-23). Approval from the Danish Medical Research Ethics Committees (Case number: 2212291) and the Danish Medicines Agency was obtained under EudraCT Number: 2022-002780-30 and Sponsor's Protocol Code Number: 9515., Competing Interests: Declaration of competing interest NBF has received consultancy fees from PharmNovo, Vertex, NeuroPN, Saniona, Nanobiotix, and Neurvati, and has undertaken consultancy work for Aarhus University with remunerated work for Biogen, Merz, and Confo Therapeutics. She has received grants from IMI2PainCare an EU IMI 2 (Innovative medicines initiative) public-private consortium and the companies involved are: Grunenthal, Bayer, Eli Lilly, Esteve, and Teva, outside the submitted work. All other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
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