@article{ref1,
title="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",
journal="BMC psychiatry",
year="2013",
author="Cipriani, Andrea and Girlanda, Francesca and Agrimi, Emilia and Barichello, Andrea and Beneduce, Rossella and Bighelli, Irene and Bisoffi, Giulia and Bisogno, Alfredo and Bortolaso, Paola and Boso, Marianna and Calandra, Carmela and Cascone, Liliana and Corbascio, Caterina and Parise, Vincenzo Fricchione and Gardellin, Francesco and Gennaro, Daniele and Hanife, Batul and Lintas, Camilla and Lorusso, Marina and Luchetta, Chiara and Lucii, Claudio and Cernuto, Francesco and Tozzi, Fiorella and Marsilio, Alessandra and Maio, Francesca and Mattei, Chiara and Moretti, Daniele and Appino, Maria Grazia and Nosè, Michela and Occhionero, Guglielmo and Papanti, Duccio and Pecile, Damiano and Purgato, Marianna and Prestia, Davide and Restaino, Francesco and Sciarma, Tiziana and Ruberto, Alessandra and Strizzolo, Stefania and Tamborini, Stefania and Todarello, Orlando and Ziero, Simona and Zotos, Spyridon and Barbui, Corrado",
volume="13",
number="1",
pages="212-212",
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 (http://clinicaltrials.gov/ct2/show/NCT00927550?term=NCT00927550&rank=1).<p /> <p>Language: en</p>",
language="en",
issn="1471-244X",
doi="10.1186/1471-244X-13-212",
url="http://dx.doi.org/10.1186/1471-244X-13-212"
}