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

Corrado Barbui^1,10  Spyridon Zotos⁸  Simona Ziero^1,11  Orlando Todarello^1,13  Stefania Tamborini⁷  Stefania Strizzolo^1,14  Alessandra Ruberto^2,20  Tiziana Sciarma^1,19  Francesco Restaino^2,21  Davide Prestia⁴  Marianna Purgato^1,10  Damiano Pecile^1,10  Duccio Papanti^2,22  Guglielmo Occhionero^1,11  Michela Nosè^1,10  Maria Grazia Appino^1,15  Daniele Moretti^1,15  Chiara Mattei⁴  Francesca Maio²  Alessandra Marsilio⁸  Fiorella Tozzi^1,12  Francesco Cernuto^1,12  Claudio Lucii^1,12  Chiara Luchetta^2,22  Marina Lorusso^1,13  Camilla Lintas⁶  Batul Hanife^1,10  Daniele Gennaro^1,17  Francesco Gardellin^1,14  Vincenzo Fricchione Parise¹  Caterina Corbascio²  Liliana Cascone^1,16  Carmela Calandra⁵  Marianna Boso³  Paola Bortolaso⁹  Alfredo Bisogno^1,16  Giulia Bisoffi^1,18  Irene Bighelli^1,10  Rossella Beneduce^2,23  Andrea Barichello^1,10  Emilia Agrimi⁷  Francesca Girlanda^1,10  Andrea Cipriani^1,10 

[1] Asl Avellino (Regione Campania), U.O.C. di Salute Mentale di Avellino, Avellino, Italy;Dipartimento di Salute Mentale, Asl AT, Asti, 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;Clinica Psichiatrica dell’Università di Genova, Genova, Italy;Azienda Ospedaliero Universitaria, "Policlinico-Vittorio Emanuele", Catania, Italy;1° Servizio autonomo di Psichiatria, Ulss 20, Verona, Italy;Servizio Psichiatrico di Diagnosi e Cura, Istituti Ospitalieri di Cremona, Cremona, Italy;Dipartimento di Salute Mentale, Ulss 18, Rovigo, Italy;Servizio Psichiatrico di Diagnosi e Cura Cittiglio, Psichiatria del presidio del Verbano, Ospedale di Circolo e Fondazione Macchi, Varese, 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, Verona, 10 – 37134, Italy;S.O.C Psichiatria Asti Centro-Nord, Asl AT, Asti, Italy;Azienda Usl 7, UFSMA Zona Altavaldelsa, Colle Val D’Elsa, Siena, Italy;Università di Bari, Bari, Italy;Dipartimento di Salute Mentale, Ulss 6, Vicenza, 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;Azienda Ospedaliera SS Antonio e Biagio, Alessandria, Italy;Ufficio Supporto alla Ricerca e Biostatistica, Azienda Ospedaliera di Verona, Verona, Italy;Dipartimento di Medicina Clinica e Sperimentale, Sezione di Psichiatria, Psicologia Clinica e Riabilitazione Psichiatrica, Perugia, Italy;Azienda Sanitaria Regionale del Molise, Servizio Psichiatrico di Diagnosi e Cura, Ospedale di Termoli, Termoli, Italy;Azienda Ospedaliera G. Salvini, U.O.P. n°62, Garbagnate Milanese, Italy;Dipartimento di Salute Mentale, Azienda per i Servizi Sanitari n°1 Triestina, Trieste, Regione FVG, Italy;IRCCS "Centro San Giovanni di Dio" FBF, Brescia, Italy

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

Others  :  1123981
DOI  :  10.1186/1471-244X-13-212

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

【 摘 要 】

Background

Data 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/Design

We 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.

Discussion

The 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 registration

ClinicalTrials.gov identifier: NCT00927550

【 授权许可】

   
2013 Cipriani et al.; licensee BioMed Central Ltd.

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