41 research outputs found

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

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    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

    Demographic and clinical determinants of neck pain in idiopathic cervical dystonia.

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    Cervical dystonia is associated with neck pain in a significant proportion of cases, but the mechanisms underlying pain are largely unknown. In this exploratory study, we compared demographic and clinical variables in cervical dystonia patients with and without neck pain from the Italian Dystonia Registry. Univariable and multivariable logistic regression analysis indicated a higher frequency of sensory trick and a lower educational level among patients with pain

    LAST-RD STUDY \u2013 LITHIUM AND STANDARD THERAPY IN RESISTANT DEPRESSION. RANDOMIZED EVALUATION OF THE EFFECTIVENESS OF LITHIUM IN SUBJECTS WITH TREATMENT-RESISTANT DEPRESSION AND SUICIDE RISK. AN INDEPENDENT, PRAGMATIC, MULTICENTRE, PARALLEL-GROUP, SUPERIORITY TRIAL.

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    Introduzione: Nella depressione resistente al trattamento (DRT), le idee autolesive e suicidarie rappresentano sintomi psicopatologici allarmanti. Questi possono portare a gesti autolesivi e tentativi di suicidio e, nel 10 % dei casi, a suicidi completi. Il trattamento conseguente al comportamento suicidario non-fatale \ue8 rilevante per la prevenzione del suicidio, perch\ue9 il rischio di suicidio in seguito a gesti autolesivi \ue8 notevole. Obiettivo: L'obiettivo primario dello Studio LAST \ue8 valutare se il litio \ue8 efficace nel ridurre il rischio di suicidio in soggetti con DRT e rischio di suicidio. Scopi secondari dello studio sono valutare se il litio \ue8 efficace nel migliorare la sintomatologia depressiva e valutare il profilo di tollerabilit\ue0 del litio. Metodi : LAST \ue8 uno studio multicentrico che mira a includere soggetti affetti da depressione resistente al trattamento con una storia di tentativi di suicidio o di gesti autolesivi nei 12 mesi precedenti. I pazienti che soddisfano i criteri di inclusione sono stati assegnati, tramite una procedura di randomizzazione centralizzata, al litio in aggiunta al trattamento farmacologico e non farmacologico standard o al trattamento farmacologico e non farmacologico standard. Risultati: Dei 58 pazienti valutati per l'inclusione, un totale di 56 sono stati arruolati nello studio e randomizzati al trattamento. Di questi, 29 soggetti sono stati assegnati al litio (gruppo sperimentale) e 27 alla terapia standard (gruppo di controllo). Le curve di sopravvivenza hanno evidenziato che il numero di eventi (considerando solo il primo evento) che si sono verificati durante il periodo di follow-up non \ue8 significativamente diverso tra i due gruppi di trattamento (Chi2 = 0.12 , p = 0,726 ). La probabilit\ue0 di sopravvivenza a 12 mesi \ue8 del 75% e 65% nel gruppo litio e nel gruppo terapia standard, rispettivamente. Conclusioni: In questo studio il trattamento con litio non \ue8 associato ad un minor rischio di suicidio e gesti autolesivi in soggetti adulti con depressione resistente al trattamento a rischio suicidario.Background: In treatment-resistant depression (TRD), self-harm and suicide ideas represent alarming psychopathological symptoms. These may lead to self-harm and suicide attempts and, in up to 10% of cases, to completed suicides. The intervention following non-fatal suicidal behavior is relevant to suicide prevention, because the risk of suicide following deliberate self-harm is considerable. Objective: The primary aim of the LAST study is to assess whether lithium is effective in reducing the risk of suicidal behavior in subjects with TRD and suicide risk. Secondary aims of the study are to assess whether lithium is effective in improving depressive symptomatology and to evaluate the tolerability profile of lithium. Methods: LAST is a multicentre trial that aimed to include subjects affected by treatment-resistant depression with a history of attempted suicide or deliberate self-harm in the previous 12 months. Patients meeting eligibility criteria were allocated, through a centralized randomization procedure, to lithium plus usual pharmacological and non pharmacological treatment or to usual pharmacological and non pharmacological treatment. Results: Of 58 patients screened for inclusion, a total of 56 were enrolled in the study and randomly assigned to treatment. Of them, 29 subjects were allocated to lithium (experimental group) and 27 were assigned to standard therapy (control group). Survival curves highlighted that the number of events (considering first event only) occurred during the follow-up period was not significantly different between the two treatment groups (Chi2=0.12, p=0.726). The survival probability at 12 month was 75% and 65% in the lithium and standard therapy group, respectively. Conclusions: In this study lithium treatment was not associated with lower risk of completed suicide and deliberate self-harm in adults affected by treatment-resistant depression with suicide risk. Funding: LAST has been approved and financially supported by the Agenzia Italiana del Farmaco (AIFA), Cod: FARM77Z3BL

    Rigour of development of clinical practice guidelines for the pharmacological treatment of bipolar disorder: systematic review

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    Background: There is art increasing concern about the quality of clinical practice guidelines. Because no information is available on the rigour of development of clinical practice guidelines for bipolar disorder, we carried out a systematic review of those focusing on its pharmacological treatment. Methods: We searched the National Guideline Clearinghouse, MEDLINE, EMBASE, PsychINFO and CINHAL for guidelines published from 2003 to 2014. The quality of each guideline was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II). Results: Fourteen guidelines were appraised. The overall quality of included guidelines varied considerably, both within and across AGREE II domains. Overall, six guidelines were rated as "recommended", two "recommended with modifications", and six were not recommended according to AGREE 11 ratings. The mean score for rigour of development was 46.8% of the maximum possible score, with no guidelines scoring the maximum score in this domain. Guidelines with lower editorial independence scores also had lower rigour of development scores, whereas those with higher-quality domain scores scored high in both domains. Limitations: As current appraisal focused on guidelines for the pharmacological treatment of bipolar disorder, it will be important to critically assess the rigour of development of other guidelines for bipolar and other psychiatric disorders. Conclusions: Health care providers, policy makers, physicians and patients alike need to be aware of the variability in guideline quality and identify the high-quality guidelines that meet their needs. (C) 2014 Elsevier B.V All rights reserved

    Implementation of treatment guidelines for specialist mental health care of severely mentally ill patients

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    This is a protocol for a systematic review. The review aims to examine the efficacy of guideline implementation strategies in improving process outcomes (performance of healthcare providers) and patient outcomes, and to explore the performance of different strategies for guideline implementation. Studies examining any active or passive guideline implementation strategy for the treatment of adults with severe mental disorders, namely schizophrenia, psychosis, bipolar disorder, and severe depression will be included. The review will include RCTs regardless of the randomisation level (patient, or health care provider), controlled clinical trials (CCT), controlled "before and after" (CBA) studies and observational studies

    Implementation of treatment guidelines for specialist mental health care of severely mentally ill patients

    No full text
    This is a protocol for a systematic review. The review aims to examine the efficacy of guideline implementation strategies in improving process outcomes (performance of healthcare providers) and patient outcomes, and to explore the performance of different strategies for guideline implementation. Studies examining any active or passive guideline implementation strategy for the treatment of adults with severe mental disorders, namely schizophrenia, psychosis, bipolar disorder, and severe depression will be included. The review will include RCTs regardless of the randomisation level (patient, or health care provider), controlled clinical trials (CCT), controlled "before and after" (CBA) studies and observational studies

    COGNITIVE PROCESSING OF SENSORY STIMULI IN CERVICAL DYSTONIA

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    Objective: Investigation of spatial and temporal recognition in Cervical Dystonia (CD). Methods: Four neuropsychological tasks, based on perception in time and space domains of visual and acoustic stimuli, were given to twenty-two CD patients and twenty-two age-matched healthy controls (C). Repeated measure ANOVA was run on group (CD, C), either pooling type of task (spatial, temporal) and type of stimuli (visual, acoustic) factors coming from all tasks either investigating single tasks. Results: In pooled analysis we found that CD were less accurate than C (F¼6.080, p¼0.018). In particular CD were worse in spatial-acoustic task (F¼5.839, p¼0.020). Significant differences were detected, evaluating reaction times, in spatial-visual task as well as in temporal-visual tasks. By considering a congruent, incongruent (opposite) or uninformative directional cue before actual stimuli, an interaction involving groups and congruency level was also found (F¼4.540, p¼0.016). This was caused by reaction times decreasing in CD during incongruent condition. C were faster than CD in temporal-visual task (F¼4.852, p¼0.035). Conclusions: This study demonstrate that CD show spatial and temporal higher cognitive impairment when processing visual and acoustic stimuli suggesting that specific neural-rehabilitative treatment should be conceived to compensate for these perceptual deficits
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