Cost-utility analysis of transcranial direct current stimulation (tDCS) in non-treatment-resistant depression: the DISCO randomised controlled study protocol. Issue 1 (13th January 2020)

• Record Type: Journal Article
• Authors: Sauvaget, Anne; Lagalice, Lydie; Schirr-Bonnans, Solène; Volteau, Christelle; Péré, Morgane; Dert, Cécile; Rivalland, Annabelle; Tessier, Fabienne; Lepage, Adeline; Tostivint, Agathe; Deschamps, Thibault; Thomas-Ollivier, Véronique; Robin, Alison; Pineau, Noémie; Cabelguen, Clémence; Bukowski, Nicolas; Guitteny, Marie; Beslot, Auxane; Simons, Luc; Network, HUGOPSY; Vanelle, Jean-Marie; D'Urso, Giordano; Bulteau, Samuel; Riche, Valéry-Pierre
• Other Names: author non-byline.; Gohier Bénédicte author non-byline.; Rozet Marine author non-byline.; Bennabi Djamila author non-byline.; Haffen Emmanuel author non-byline.; Daudet Christophe author non-byline.; Samalin Ludovic author non-byline.; Llorca Pierre-Michel author non-byline.; Trojak Benoît author non-byline.; Chauvet-Gélinier Jean-Christophe author non-byline.; Poulet Emmanuel author non-byline.; Magnin Charline author non-byline.; Mouchabac Stéphane author non-byline.; Germaneau Ghina Harika author non-byline.; Jaafari Nemat author non-byline.; Drapier Dominique author non-byline.; Batail Jean-Marie author non-byline.; Rotharmel Maud author non-byline.; Berjamin Caroline author non-byline.; El Hage Wissam author non-byline.; Desmidt Thomas author non-byline.
• Is Part Of: BMJ open. Volume 10:Issue 1(2020)
• Publication Date: 2020-01-13
• Subjects: depression & mood disorders -- treatment -- tDCS -- cost-utility -- quality of life -- study protocol; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2019-033376
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: Depression is among the most widespread psychiatric disorders in France. Psychiatric disorders are associated with considerable social costs, amounting to €22.6 billion for treatment and psychotropic medication in 2011. Treatment as usual (TAU), mainly consisting of pharmacotherapy and psychotherapy, is effective for only a third of patients and in most cases fails to prevent treatment resistance and chronicity. Transcranial direct current stimulation (tDCS) consists in a non-invasive and painless application of low-intensity electric current to the cerebral cortex through the scalp. Having proved effective in depressed patients, it could be used in combination with TAU to great advantage. The objective is to compare, for the first time ever, the cost-utility of tDCS-TAU and of TAU alone for the treatment of a depressive episode that has been refractory to one or two drug treatments. Methods and analysis: This paper, based on the DISCO study protocol, focuses on the design of a prospective, randomised, controlled, open-label multicentre economic study to be conducted in France. It will include 214 patients with unipolar or bipolar depression, assigning them to two parallel arms: group A (tDCS-TAU) and group B (TAU alone). The primary outcome is the incremental cost-effectiveness ratio, that is, the ratio of the difference in cost between each strategy to the difference in their effects. Their effects will be expressed as numbers of quality-adjusted life-years, determined through administration of the EuroQol Five-Dimension questionnaire over a 12-month period to patients (EQ-5D-5L). Expected benefits are the reduction of treatment resistance and suicidal ideation as well as social and professional costs of depression. Should depression-related costs fall significantly, tDCS might be considered an efficient treatment for depression. Ethics and dissemination: This protocol has been approved by a French ethics committee, the CPP-–Est IV (Comité de Protection des Personnes–Strasbourg). Data are to be published in peer-reviewed medical journals. Trial registration number: RCB 2018-A00474-51; NCT03758105