Article Text
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
- depression & mood disorders
- treatment
- tDCS
- cost-utility
- quality of life
- study protocol
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Footnotes
Twitter @Fabienne TESSIER
Collaborators DISCO investigators group: Bénédicte Gohier (Department of Psychiatry and Addictology, Angers University Hospital, University, UPRES EA 4638, University of Angers, 49100 Angers), Marine Rozet (Department of Psychiatry and Addictology, Angers University Hospital, University, UPRES EA 4638, University of Angers, 49100 Angers), Djamila Bennabi (Service de Psychiatrie, CIC-1431 INSERM, CHU de Besançon, F-25000 Besançon, France ; laboratoire de Neurosciences, Université Bourgogne Franche-Comté, F-25000 Besançon, France), Emmanuel Haffen (Service de Psychiatrie, CIC-1431 INSERM, CHU de Besançon, F-25000 Besançon, France ; laboratoire de Neurosciences, Université Bourgogne Franche-Comté, F-25000 Besançon, France), Christophe Daudet (Clinique Mirambeau 22 Avenue De Maignon, 64600 Anglet, France), Ludovic Samalin (CHU Clermont-Ferrand, Department of Psychiatry, University of Clermont Auvergne, EA 7280, Clermont-Ferrand, France; Fondation Fondamental, Créteil, France), Pierre-Michel Llorca (CHU Clermont-Ferrand, Department of Psychiatry, University of Clermont Auvergne, EA 7280, Clermont-Ferrand, France; Fondation Fondamental, Créteil, France), Benoît Trojak (University Hospital of Dijon, Department of Psychiatry and Addictology, 21079 Dijon, France), Jean-Christophe Chauvet-Gélinier (Psychiatry unit, department of neurosciences, university hospital, CHU de Le Bocage, Bâtiment Marion, 14, rue Gaffarel, 21000 Dijon, France; Inserm LNC-UMR 1231, 21000 Dijon, France), Emmanuel Poulet (INSERM, U1028; CNRS, UMR5292; Lyon Neuroscience Research Center, Psychiatric Disorders: from Resistance to Response Team, Lyon, F-69000, France; University Lyon 1, Villeurbanne, F-69000, France; Department of Emergency Psychiatry, University Hospital Edouard Herriot, Hospices civils de Lyon, Lyon, France), Charline Magnin (INSERM, U1028; CNRS, UMR5292; Lyon Neuroscience Research Center, Psychiatric Disorders: from Resistance to Response Team, Lyon, F-69000, France; University Lyon 1, Villeurbanne, F-69000, France; Department of Emergency Psychiatry, University Hospital Edouard Herriot, Hospices civils de Lyon, Lyon, France), Stéphane Mouchabac (Sorbonne Universités, département de psychiatrie adulte et de psychologie médicale, AP-HP, hôpital Saint-Antoine, Paris, France), Ghina Harika Germaneau (Université de Poitiers, Unité de recherche clinique intersectorielle en psychiatrie à vocation régionale Pierre Deniker du Centre Hospitalier Henri Laborit F-86022 France ; Groupement De Recherche CNRS 3557), Nemat Jaafari (Université de Poitiers, Unité de recherche clinique intersectorielle en psychiatrie à vocation régionale Pierre Deniker du Centre Hospitalier Henri Laborit F-86022 France; Groupement De Recherche CNRS 3557), Dominique Drapier (Centre Hospitalier Guillaume Régnier, 108 avenue général leclerc 35 703 Rennes ; EA 4712 Comportements et noyaux gris centraux, Université Rennes 1, France), Jean-Marie Batail (Centre Hospitalier Guillaume Régnier, 108 avenue général leclerc 35 703 Rennes ; EA 4712 Comportements et noyaux gris centraux, Université Rennes 1, France), Maud Rotharmel (Service Hospitalo-Universitaire, Centre Hospitalier du Rouvray, 4, rue Paul Eluard, 76300 Sotteville-lès-Rouen, France), Caroline Berjamin (Service Hospitalo-Universitaire, Centre Hospitalier du Rouvray, 4, rue Paul Eluard, 76300 Sotteville-lès-Rouen, France), El-Hage Wissam (CHRU de Tours, Pôle de Psychiatrie, Tours, France ; UMR 1253, iBrain, Université de Tours, Inserm, Tours, France ; CIC 1415, Centre d’Investigation Clinique, Inserm, CHRU de Tours, Tours, France), Desmidt Thomas (CHRU de Tours, Pôle de Psychiatrie, Tours, France ; UMR 1253, iBrain, Université de Tours, Inserm, Tours, France).
Contributors AS, CV, SS-B, MP, AT, SB, J-MV, V-PR and MG designed the study and developed its protocol. AS is the study coordinator. AS, LL, GD'U, V-PR and SCB wrote the first version of the manuscript. AS, SB, CC, NB, MG, AB, LS, the HUGOPSY network, the DISCO investigators group are investigators and responsible for enrolment, determining treatment indications and data collection. All the authors (AS, LL, SS-B, CV, MP, CD, AR, FT, AL, AT, TD, VT-O, AR, NP, CC, NB, MG, AB, LS, BG, MR, DB, EH, CD, LS, P-ML, BT, J-CC-G, EP, CM, SM, NJ, GHG, DD, J-MB, MR, CB, E-HW, TD, J-MV, GD'U, V-PR) are involved in the data acquisition. CD is the project manager, helped with general organisation and sought ethical and regulatory approval. FT and AR are projects manager assistants. FT, AR, AP, AL, AR and LL contributed to tDCS administration and treatment planning. V-PR, MP and CV are responsible for calculating statistical power and performing statistical analyses. FT, LL, TD, VT-O, NP and AB are in charge of planning, randomisation and completion of electronic case report forms. All the authors read the draft critically, and approved the final version. All the authors agreed to be accountable for all aspects of the work.
Funding This work was supported by the French Ministry of Health (project PRME-17-0097).
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval This study has been approved by a French ethics committee, the CPP–Est IV (Comité de Protection des Personnes–Strasbourg) (RCB no. 2018-A00474-51; ERB no. 18/75) and designed in accordance with the Declaration of Helsinki (final 2004 version) and French legislation (articles L1121-160 and L1126-7 of the French public health code).
Provenance and peer review Not commissioned; externally peer reviewed.