Effectiveness of lithium in subjects with treatment-resistant depression and suicide risk: results and lessons of an underpowered randomised clinical trial.

BACKGROUND: As 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. METHODS: We 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. RESULTS: Of 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. CONCLUSIONS: The 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 REGISTRATION: ClinicalTrials.gov identifier: NCT00927550.

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.

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.

Internet addiction disorder: prevalence in an Italian student population.

BACKGROUND: Internet addiction is one of the latest forms of addiction that has attracted the attention of popular media and researchers in these last few years. Several authors think Internet addiction is a separate disorder that merits inclusion in DSM-V. There is considerable controversy about this opinion. AIMS: The aim of this study was to assess the prevalence of Internet addiction in a representative sample of high school students attending secondary institutions in the district of Cremona and to assess any difference concerning variables such as gender, age, place of residence and kind of school attended. METHODS: The Italian version of the Internet Addiction Test (IAT) has been administered to a sample of 2533 students from different kinds of school. The survey also required social and demographic data. RESULTS: The majority of respondents were classified as normal users of the Internet (n = 2386, 94.19%), with 127 (5.01%) moderately addicted and 20 (0.79%) seriously addicted. Significant differences in gender and in kinds of school were found. No statistical differences were revealed in age and urban or rural conditions. CONCLUSIONS: 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.

Effectiveness of different modalities of cognitive remediation on symptomatological, neuropsychological, and functional outcome domains in schizophrenia: a prospective study in a real-world setting.

OBJECTIVES: The efficacy of cognitive remediation interventions in schizophrenia has been demonstrated in several experimental studies. However, the effectiveness of such treatments in the usual setting of care of schizophrenia and a direct comparison of different modalities of interventions have not been systematically analyzed. The aim of the study was to assess the effectiveness of the cognitive subprograms of Integrated Psychological Therapy (IPT-cog) and of a computer-assisted cognitive remediation (CACR) method on symptomatological, neuropsychological and functional outcome measures in schizophrenia. METHODS: Ninety patients with schizophrenia were assigned to IPT-cog, CACR or usual rehabilitative interventions (REHAB) in a naturalistic setting of care. Clinical, neuropsychological, and functional outcome variables were assessed at baseline and after 24 weeks of treatment. RESULTS: Both the IPT-cog and CACR groups improved more than the comparison group with respect to all outcome variables. The more responsive cognitive domains were speed of processing and working memory. The effectiveness of the 2 remediation methods on the outcome dimensions considered was comparable. However, IPT-cog, but not CACR, was more effective than REHAB on speed of processing, and the CACR group had better outcome than both the REHAB and the IPT-cog groups when the Health of the Nation Outcome Scale was considered. Few correlations between neurocognitive and functional outcome changes were found. CONCLUSIONS: The study demonstrates the effectiveness, although nongeneralized, of IPT-cog and CACR in schizophrenia when applied within a psychiatric and psychosocial treatment regimen representative of the usual setting and modality of care, with no evident superiority of any of the methods, and indicates that the changes in functional outcome during treatment are modestly mediated by improvement in specific cognitive domains.