Our study has confirmed the general use of the Internet among youngest people, the emergence of Internet addiction and the male preponderance of this phenomenon.
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
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
Cognitive deficits are a core feature of schizophrenia and the need for a simple and reliable method for assessment of cognitive functions in schizophrenia is well recognized. The Schizophrenia Cognition Rating Scale (SCoRS) has proved to be a valid measure of neurocognitive performance and to correlate with the psychosocial functioning of schizophrenic patients. Aim of the present study was to investigate the correlations among global ratings of the Italian version of the SCoRS and measures of cognitive performance, symptoms severity and psychosocial functioning in schizophrenic subjects. We intended also to test the SCoRS sensitiviity to change over time, in relation also to changes of the above mentioned clinical, neurocognitive and outcome parameters. Forty-eight patients with schizophrenia (29 males, 19 female; mean age 39.1 years) were assessed at baseline and after three months of usual outpatient treatment according to the Italian community assertive treatment program, with the following instruments:1)SCoRS;2)comprehensive neuropsychological battery;3)the Positive And Negative Syndrome Scale and the Clinical Global Impression;4)the Global Assessment of Functioning, the Health of the Nation Outcome Scale, the Camberwell Assessment of Needs scale.At baseline, SCoRS global ratings significantly correlated with the composite scores of cognitive performance, with positive, negative and total PANSS scores and with all measures of psychosocial functioning. Conversely, SCoRS global ratings did not change significantly over the 3-month follow up and the changes from baseline did not significantly correlate with the changes of neurocognitive, clinical and functional assessments over the same time period.
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