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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

The aim of the present study was to retrospectively review the charts of obsessive-compulsive disorder (OCD) patients who responded to the addition of an antipsychotic to the seroronin reuptake inhibitor (SRI), and who subsequently discontinued the antipsychotic, in order to evaluate whether antipsychotic discontinuation resulted in a relapse of the disorder. Charts of patients with a principal diagnosis of OCD (DSM-IV) treated with pharmacotherapy were reviewed in order to select patients who: (i) did not respond to a trial with a first-line drug (clomipramine or a selective SRI); (ii) received an antipsychotic at low doses (haloperidol, pimozide, risperidone or olanzapine) in order to potentiate the SRI; (iii) responded to this augmentation strategy; and (iv) discontinued the antipsychotic drug for any reason while continuing the SRI at the same dose. Relapse was defined as a worsening of Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score >/= 35% with respect to last evaluation before antipsychotic discontinuation or, for patients with a Y-BOCS < 16 at the end of the combination period, as a Y-BOCS total score >/= 16 at any time after antipsychotic discontinuation. According to our definition of relapse, 15 patients out of 18 (83.3%) relapsed after antipsychotic discontinuation, with a mean worsening of symptoms of 6.6 +/- 1.7 points in the Y-BOCS total score. Thirteen patients out of the 15 who relapsed did so by week 8 after discontinuation. Two subjects relapsed at the end of the 1-year study. Although retrospective, our study provides initial evidence that antipsychotic augmentation has to be maintained for patients who respond to this strategy, because the vast majority of subjects who discontinue the antipsychotic relapse within 2 months.