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Open Access Study protocol

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

Andrea Cipriani1*, Francesca Girlanda1, Emilia Agrimi2, Andrea Barichello1, Rossella Beneduce3, Irene Bighelli1, Giulia Bisoffi4, Alfredo Bisogno5, Paola Bortolaso6, Marianna Boso7, Carmela Calandra8, Liliana Cascone5, Caterina Corbascio9, Vincenzo Fricchione Parise10, Francesco Gardellin11, Daniele Gennaro12, Batul Hanife1, Camilla Lintas13, Marina Lorusso14, Chiara Luchetta15, Claudio Lucii16, Francesco Cernuto16, Fiorella Tozzi16, Alessandra Marsilio17, Francesca Maio9, Chiara Mattei18, Daniele Moretti19, Maria Grazia Appino19, Michela Nosè1, Guglielmo Occhionero20, Duccio Papanti15, Damiano Pecile1, Marianna Purgato1, Davide Prestia18, Francesco Restaino21, Tiziana Sciarma22, Alessandra Ruberto23, Stefania Strizzolo11, Stefania Tamborini2, Orlando Todarello14, Simona Ziero20, Spyridon Zotos17 and Corrado Barbui1

Author Affiliations

1 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

2 Servizio Psichiatrico di Diagnosi e Cura, Istituti Ospitalieri di Cremona, Cremona, Italy

3 IRCCS "Centro San Giovanni di Dio" FBF, Brescia, Italy

4 Ufficio Supporto alla Ricerca e Biostatistica, Azienda Ospedaliera di Verona, Verona, Italy

5 Dipartimento di Salute Mentale, UO Salute Mentale Cava de'Tirreni - Costa d'Amalfi, ASL Salerno, Italy

6 Servizio Psichiatrico di Diagnosi e Cura Cittiglio, Psichiatria del presidio del Verbano, Ospedale di Circolo e Fondazione Macchi, Varese, Italy

7 Dipartimento di Scienze Applicate e Psicocomportamentali, Sezione di Psichiatria, Università di Pavia e Centro Psico-Sociale di Pavia, Azienda Ospedaliera di Pavia, Pavia, Italy

8 Azienda Ospedaliero Universitaria, "Policlinico-Vittorio Emanuele", Catania, Italy

9 Dipartimento di Salute Mentale, Asl AT, Asti, Italy

10 Asl Avellino (Regione Campania), U.O.C. di Salute Mentale di Avellino, Avellino, Italy

11 Dipartimento di Salute Mentale, Ulss 6, Vicenza, Italy

12 Azienda Ospedaliera SS Antonio e Biagio, Alessandria, Italy

13 1° Servizio autonomo di Psichiatria, Ulss 20, Verona, Italy

14 Università di Bari, Bari, Italy

15 Dipartimento di Salute Mentale, Azienda per i Servizi Sanitari n°1 Triestina, Trieste, Regione FVG, Italy

16 Azienda Usl 7, UFSMA Zona Altavaldelsa, Colle Val D’Elsa, Siena, Italy

17 Dipartimento di Salute Mentale, Ulss 18, Rovigo, Italy

18 Clinica Psichiatrica dell’Università di Genova, Genova, Italy

19 Dipartimento di Salute Mentale, Centro di Salute Mentale di Finale Ligure, Asl n°2, Savona, Italy

20 S.O.C Psichiatria Asti Centro-Nord, Asl AT, Asti, Italy

21 Azienda Ospedaliera G. Salvini, U.O.P. n°62, Garbagnate Milanese, Italy

22 Dipartimento di Medicina Clinica e Sperimentale, Sezione di Psichiatria, Psicologia Clinica e Riabilitazione Psichiatrica, Perugia, Italy

23 Azienda Sanitaria Regionale del Molise, Servizio Psichiatrico di Diagnosi e Cura, Ospedale di Termoli, Termoli, Italy

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BMC Psychiatry 2013, 13:212  doi:10.1186/1471-244X-13-212

Published: 13 August 2013

Abstract

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

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