Cost-Utility Analysis of Curative and Maintenance Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment-Resistant Unipolar Depression: A Randomized Controlled Trial Protocol - Archive ouverte HAL Accéder directement au contenu
Article Dans Une Revue Trials Année : 2020

Cost-Utility Analysis of Curative and Maintenance Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment-Resistant Unipolar Depression: A Randomized Controlled Trial Protocol

Résumé

BACKGROUND: Depression is a debilitating and costly disease for our society, especially in the case of treatment-resistant depression (TRD). Repetitive transcranial magnetic stimulation (rTMS) is an effective adjuvant therapy in treatment-resistant unipolar and non-psychotic depression. It can be applied according to two therapeutic strategies after an initial rTMS cure: a further rTMS cure can be performed at the first sign of relapse or recurrence, or systematic maintenance rTMS (M-rTMS) can be proposed. TMS adjuvant to treatment as usual (TAU) could improve long-term prognosis. However, no controlled study has yet compared the cost-effectiveness of these two additional rTMS therapeutic strategies versus TAU alone. METHODS/DESIGN: This paper focuses on the design of a health-economic, prospective, randomized, double-blind, multicenter study with three parallel arms carried out in France. This study assesses the cost-effectiveness of the adjunctive and maintenance low frequency rTMS on the right dorsolateral prefrontal cortex versus TAU alone. A total of 318 patients suffering from a current TRD will be enrolled. The primary endpoint is to investigate the incremental cost-effectiveness ratio (ICER) (ratio costs / quality-adjusted life-years [QALY] measured by the Euroqol Five Dimension Questionnaire) over 12\,months in a population of patients assigned to one of three arms: systematic M-rTMS for responders (arm A); additional new rTMS cure in case of mood deterioration among responders (arm B); and a placebo arm (arm C) in which responders are allocated in two subgroups: sham systematic M-rTMS and supplementary rTMS course in case of mood deterioration. ICER and QALYs will be compared between arm A or B versus arm C. The secondary endpoints in each three arms will be: ICER at 24\,months; the cost-utility ratio analysis at 12 and 24\,months; 5-year budget impact analysis; and prognosis factors of rTMS. The following criteria will be compared between arm A or B and arm C: rates of responders; remission and disease-free survival; clinical evolution; tolerance; observance; treatment modifications; hospitalization; suicide attempts; work stoppage; marital / professional statues; and quality of life at 12 and 24\,months. DISCUSSION: The purpose of our study is to check the cost-effectiveness of rTMS and we will discuss its economic impact over time. In the case of significant decrease in the depression costs and expenditures associated with a good long-term prognosis (sustained response and remission) and tolerance, rTMS could be considered as an efficient treatment within the armamentarium for resistant unipolar depression. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03701724. Registered on 10 October 2018. Protocol Amendment Version 2.0 accepted on 29 June 2019.
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hal-03159452 , version 1 (09-12-2023)

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Samuel Bulteau, Andrew Laurin, Christelle Volteau, Cécile Dert, Lydie Lagalice, et al.. Cost-Utility Analysis of Curative and Maintenance Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment-Resistant Unipolar Depression: A Randomized Controlled Trial Protocol. Trials, 2020, 21 (1), pp.312. ⟨10.1186/s13063-020-04255-9⟩. ⟨hal-03159452⟩
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