Effectiveness of lithium in subjects with treatment-resistant depression and suicide risk: a protocol for a randomised, independent, pragmatic, multicentre, parallel-group, superiority clinical trial

BMC Psychiatry

Study Protocol

Camilla Lintas¹  Vincenzo Fricchione Parise²  Francesco Restaino³  Daniele Gennaro⁴  Carmela Calandra⁵  Alessandra Ruberto⁶  Claudio Lucii⁷  Fiorella Tozzi⁷  Francesco Cernuto⁷  Chiara Mattei⁸  Davide Prestia⁸  Tiziana Sciarma⁹  Francesca Maio^1,10  Caterina Corbascio^1,10  Chiara Luchetta^1,11  Duccio Papanti^1,11  Daniele Moretti^1,12  Maria Grazia Appino^1,12  Alfredo Bisogno^1,13  Liliana Cascone^1,13  Spyridon Zotos^1,14  Alessandra Marsilio^1,14  Stefania Strizzolo^1,15  Francesco Gardellin^1,15  Andrea Cipriani^1,16  Francesca Girlanda^1,16  Marianna Purgato^1,16  Corrado Barbui^1,16  Andrea Barichello^1,16  Irene Bighelli^1,16  Michela Nosè^1,16  Damiano Pecile^1,16  Batul Hanife^1,16  Marianna Boso^1,17  Rossella Beneduce^1,18  Simona Ziero^1,19  Guglielmo Occhionero^1,19  Paola Bortolaso^2,20  Emilia Agrimi^2,21  Stefania Tamborini^2,21  Giulia Bisoffi^2,22  Orlando Todarello^2,23  Marina Lorusso^2,23 

[1] 1° Servizio autonomo di Psichiatria, Ulss 20, Verona, Italy;Asl Avellino (Regione Campania), U.O.C. di Salute Mentale di Avellino, Avellino, Italy;Azienda Ospedaliera G. Salvini, U.O.P. n°62, Garbagnate Milanese, Italy;Azienda Ospedaliera SS Antonio e Biagio, Alessandria, Italy;Azienda Ospedaliero Universitaria, "Policlinico-Vittorio Emanuele", Catania, Italy;Azienda Sanitaria Regionale del Molise, Servizio Psichiatrico di Diagnosi e Cura, Ospedale di Termoli, Termoli, Italy;Azienda Usl 7, UFSMA Zona Altavaldelsa, Colle Val D’Elsa, Siena, Italy;Clinica Psichiatrica dell’Università di Genova, Genova, Italy;Dipartimento di Medicina Clinica e Sperimentale, Sezione di Psichiatria, Psicologia Clinica e Riabilitazione Psichiatrica, Perugia, Italy;Dipartimento di Salute Mentale, Asl AT, Asti, Italy;Dipartimento di Salute Mentale, Azienda per i Servizi Sanitari n°1 Triestina, Trieste, Regione FVG, Italy;Dipartimento di Salute Mentale, Centro di Salute Mentale di Finale Ligure, Asl n°2, Savona, Italy;Dipartimento di Salute Mentale, UO Salute Mentale Cava de'Tirreni - Costa d'Amalfi, ASL Salerno, Italy;Dipartimento di Salute Mentale, Ulss 18, Rovigo, Italy;Dipartimento di Salute Mentale, Ulss 6, Vicenza, Italy;Dipartimento di Sanità Pubblica e Medicina di Comunità, Sezione di Psichiatria e Sezione di Psicologia Clinica, Università di Verona, Policlinico “G.B. Rossi” Piazzale L.A. Scuro, 10 – 37134, Verona, Italy;Dipartimento di Scienze Applicate e Psicocomportamentali, Sezione di Psichiatria, Università di Pavia e Centro Psico-Sociale di Pavia, Azienda Ospedaliera di Pavia, Pavia, Italy;IRCCS "Centro San Giovanni di Dio" FBF, Brescia, Italy;S.O.C Psichiatria Asti Centro-Nord, Asl AT, Asti, Italy;Servizio Psichiatrico di Diagnosi e Cura Cittiglio, Psichiatria del presidio del Verbano, Ospedale di Circolo e Fondazione Macchi, Varese, Italy;Servizio Psichiatrico di Diagnosi e Cura, Istituti Ospitalieri di Cremona, Cremona, Italy;Ufficio Supporto alla Ricerca e Biostatistica, Azienda Ospedaliera di Verona, Verona, Italy;Università di Bari, Bari, Italy;

关键词: Randomised controlled trial;    Lithium;    Suicide;    Deliberate self harm;    Mortality;    Depression;    Treatment resistant;    Antidepressant;   

DOI  :  10.1186/1471-244X-13-212

 received in 2013-02-04, accepted in 2013-08-07,  发布年份 2013

来源: Springer

【 摘 要 】

BackgroundData on therapeutic interventions following deliberate self harm (DSH) in patients with treatment-resistant depression (TRD) are very scant and there is no unanimous consensus on the best pharmacological option for these patients. There is some evidence that lithium treatment might be effective in reducing the risk of completed suicide in adult patients with unipolar affective disorders, however no clear cut results have been found so far. The primary aim of the present study is to assess whether adding lithium to standard therapy is an effective treatment strategy to reduce the risk of suicidal behaviour in long term treatment of people with TRD and previous history of DSH.Methods/DesignWe will carry out a randomised, parallel group, assessor-blinded superiority clinical trial. Adults with a diagnosis of major depression, an episode of DSH in the previous 12 months and inadequate response to at least two antidepressants given sequentially at an adequate dose for an adequate time for the current depressive episode will be allocated to add lithium to current therapy (intervention arm) or not (control arm). Following randomisation, treatment is to be taken daily for 1 year unless some clear reason to stop develops. Suicide completion and acts of DSH during the 12 months of follow-up will constitute the composite primary outcome. To preserve outcome assessor blindness, an independent adjudicating committee, blind to treatment allocation, will anonymously review all outcome events.DiscussionThe results of this study should indicate whether lithium treatment is associated with lower risk of completed suicide and DSH in adult patients with treatment resistant unipolar depression, who recently attempted suicide.Trial registrationClinicalTrials.gov identifier: NCT00927550

【 授权许可】

CC BY   
© Cipriani et al.; licensee BioMed Central Ltd. 2013