BackgroundAs lithium treatment might be effective in reducing the risk of deliberate self-harm (DSH) in adult patients with unipolar affective disorders, we designed a pragmatic randomised trial to assess its efficacy in more than 200 patients with treatment-resistant depression. However, we randomised 56 patients only. The aim of this report is therefore twofold: first, to disseminate the results of this underpowered study which may be incorporated into future meta-analytical reviews; second, to analyse some critical aspects of the study which might explain failure to reach the target sample size.MethodsWe carried 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 were allocated to add lithium to usual care (intervention arm) versus usual care alone (control arm). Suicide completion and acts of DSH during the 12 months of follow-up constituted the composite primary outcome.ResultsOf 58 patients screened for inclusion, 29 were allocated to lithium plus usual care and 27 were assigned to usual care without lithium. Six patients in the lithium plus usual care group and seven in the usual care group committed acts of DSH during the follow-up phase. The survival probability did not differ between the two treatment arms (Chi2 = 0.17, p =0.676). With regard to changes in the severity of depressive symptomatology from baseline to endpoint, no significant differences were detected.ConclusionsThe present study failed to achieve the minimum sample size needed to detect a clinically meaningful difference between the two treatment arms. Consequently, the finding that lithium, in addition to usual care, did not exert a positive effect in terms of reduction of DSH after 12 months of follow-up is likely due to the lack of sufficient statistical power to detect a difference, if a difference existed. The dissemination of the results of this underpowered study will inform future meta-analytical reviews on lithium and suicide-related outcomes.Trial registrationClinicalTrials.gov identifier: NCT00927550

ObjectivesThe objective of this study was to investigate the role that psychopathological dimensions as overt aggression and impulsivity play in determining suicide risk in benign chronic pain patients (CPPs). Furthermore we investigated the possible protective/risk factors which promote these negative feelings, analyzing the relationship between CPPs and their caregivers.MethodsWe enrolled a total of 208 patients, divided into CPPs and controls affected by internistic diseases. Assessment included collection of sociodemographic and health care data, pain characteristics, administration of visual analog scale (VAS), Modified Overt Aggression Scale (MOAS), Barratt Impulsiveness Scale Version 11 (BIS), Hamilton Depression Rating Scale (HDRS), and a caregiver self-administered questionnaire. All variables were statistically analyzed.ResultsA significant difference of VAS, MOAS-total/verbal/auto-aggression, HDRS-total/suicide mean scores between the groups were found. BIS mean score was higher in CPPs misusing analgesics. In CPPs a correlation between MOAS-total/verbal/auto-aggression with BIS mean score, MOAS with HDRS-suicide mean score and BIS with HDRS-suicide mean scores were found. The MOAS and BIS mean scores were significantly higher when caregivers were not supportive.ConclusionIn CPPs, aggression and impulsivity could increase the risk of suicide. Moreover, impulsivity, overt aggression and pain could be interrelated by a common biological core. Our study supports the importance of a multidisciplinary approach in the CPPs management and the necessity to supervise caregivers, which may become risk/protective factors for the development of feelings interfering with the treatment and rehabilitation of CPPs.

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