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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.


ABSTRACT: 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.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.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.ClinicalTrials.gov identifier: NCT00927550.

SUBMITTER: Cipriani A 

PROVIDER: S-EPMC3751729 | biostudies-literature | 2013 Aug

REPOSITORIES: biostudies-literature

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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.

Cipriani Andrea A   Girlanda Francesca F   Agrimi Emilia E   Barichello Andrea A   Beneduce Rossella R   Bighelli Irene I   Bisoffi Giulia G   Bisogno Alfredo A   Bortolaso Paola P   Boso Marianna M   Calandra Carmela C   Cascone Liliana L   Corbascio Caterina C   Parise Vincenzo Fricchione VF   Gardellin Francesco F   Gennaro Daniele D   Hanife Batul B   Lintas Camilla C   Lorusso Marina M   Luchetta Chiara C   Lucii Claudio C   Cernuto Francesco F   Tozzi Fiorella F   Marsilio Alessandra A   Maio Francesca F   Mattei Chiara C   Moretti Daniele D   Appino Maria Grazia MG   Nosè Michela M   Occhionero Guglielmo G   Papanti Duccio D   Pecile Damiano D   Purgato Marianna M   Prestia Davide D   Restaino Francesco F   Sciarma Tiziana T   Ruberto Alessandra A   Strizzolo Stefania S   Tamborini Stefania S   Todarello Orlando O   Ziero Simona S   Zotos Spyridon S   Barbui Corrado C  

BMC psychiatry 20130813


<h4>Background</h4>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  ...[more]

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