1,720,973 research outputs found
Lithium and Standard Therapy in Resistant Depression. Randomized evaluation of the effectiveness of lithium in subjects with treatment resistant depression and suicide risk
No full textBackground: It has been estimated that under ordinary circumstances up to 30-40% of patients with unipolar depression do not respond well to initial antidepressant treatment and fail to make a satisfactory improvement. International guidelines define treatment-resistant depression (TRD) as failure to respond to two or more antidepressants given sequentially at an adequate dose for an adequate time. In 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. In this difficult-to-treat patient population data on therapeutic interventions following non-fatal suicidal behavior are very scant. On the basis of the evidence collected so far it has been highlighted that lithium could have a beneficial effect to prevent deliberate self-harm, but currently there are not randomized clinical trials assessing the efficacy of lithium to reduce deliberate self-harm and suicide in patients with TRD. 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 aims to involve 60-70 Italian psychiatric services. It will 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 will be allocated, through a centralized randomization procedure, to lithium plus usual pharmacological and non pharmacological treatment or to usual pharmacological and non pharmacological treatment. After random allocation subjects will be followed over a period of 12 months and they will be evaluated at baseline and each month on pharmacological therapy, deaths and deliberate self-harm. Additional information about severity of illness will be collected at 3, 6 and 12 months. The composite primary outcome is constituted by suicide completion and acts of deliberate self-harm during the follow-up period. An independent adjudicating committee, blind to treatment allocation, will review all events that might be classified as primary outcome
LAST-RD STUDY – 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.
No full textIntroduzione: 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 è rilevante per la prevenzione del suicidio, perché il rischio di suicidio in seguito a gesti autolesivi è notevole.
Obiettivo: L'obiettivo primario dello Studio LAST è valutare se il litio è efficace nel ridurre il rischio di suicidio in soggetti con DRT e rischio di suicidio. Scopi secondari dello studio sono valutare se il litio è efficace nel migliorare la sintomatologia depressiva e valutare il profilo di tollerabilità del litio.
Metodi : LAST è 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 è significativamente diverso tra i due gruppi di trattamento (Chi2 = 0.12 , p = 0,726 ). La probabilità di sopravvivenza a 12 mesi è del 75% e 65% nel gruppo litio e nel gruppo terapia standard, rispettivamente.
Conclusioni: In questo studio il trattamento con litio non è 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
Gravidanza e contesti psicopatologici. Dalla teoria agli strumenti di intervento
No full textUn testo di pratica clinica, rivolto a medici, ostetriche, operatori socio-sanitari, psicologi. Illustra le diverse situazioni problematiche della gravidanza e del puerperio (PTSD, ansia, depressione, sessualità, diagnosi prenatale, parto, IVG, morte endouterina, vulnerabilità psicopatologica, prematurità) e i modelli, protocolli e suggerimenti specifici per ciascun contesto
Rigour of development of clinical practice guidelines for the pharmacological treatment of bipolar disorder: systematic review
No full textBackground: 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
Risvolti psicologici dell’interruzione volontaria di gravidanza: report di una ricerca empirica preliminare
No full textThe present study aims to increase knowledge about psychological repercussions due to antenatal death. First they’ll come to describe two types of pregnancy interruption happened in a spontaneous way, that is the stillbirth and the miscarriage; subsequently it will come discussed the abortion. Relatively this last thematic, it will be presented an empirical research on a total of 21 subjects, oriented to deepen the impact at a psycho physiological level of the decision to abort. At this purpose, three tests have been administer: - Beck Depression Inventory (BDI) - Symptom Check List Revised (SCL-90-R) - Satisfaction Profile (SAT-P). The administration have been made in two times: 1) the operation day 2) a month after that. Conclusions are generally concordant with previous studies, that support than the abortion doesn’t induce severe psychological and psychiatric consequences, nor in short and long terms. Intrinsic purpose of the treatment is also to pick and evidence the different blends that characterized the answers to three interruption types of pregnancy above-citeds and compare them
Guideline implementation strategies for specialist mental healthcare.
No full textPURPOSE OF REVIEW: Clinical practice guidelines in mental healthcare are viewed as an essential asset if appropriately developed and implemented. The purpose of this article was to review the existing literature on how guidelines should be implemented to optimize their impact on provider performance and patient outcomes in specialist mental healthcare settings.
RECENT FINDINGS: Findings from recent studies suggest a trend toward an improvement in process and patient outcomes following guideline implementation. However, studies are heterogeneous in terms of design, implementation strategies and outcome measures, making it very difficult to draw firm conclusions about which implementation strategy is effective in different healthcare contexts.
SUMMARY: Current knowledge about how guidelines should be implemented is still sparse and inconclusive in mental healthcare. Future studies should attempt to employ more rigorous designs, including random allocation of patients or clusters of patients, to shed further light on this compelling issue. Research on guideline implementation strategies should additionally take into account potential barriers to knowledge translation, which can heavily influence the implementability of treatment recommendation
Superiority, equivalence or non-inferiority?
No full textOne of the most important critical decision to be taken when designing a randomized controlled trial (RCT) in clinical psychopharmacology is the choice of the comparator. This choice is crucial because it affects many issues related to both internal and external validity. The aim of a RCT may be to establish efficacy in absolute terms, against an inert treatment (usually a placebo), or to establish efficacy with respect to another treatment (also known as comparator), a trial may be designed to demonstrate that the new drug is superior to the control intervention or, by contrast, that the new drug is similar to the control intervention in terms of, say, symptoms' reduction. Three kinds of RCTs may be designed: Superiority trials, Equivalence studies, Non-inferiority studies
The evidence-practice gap in specialist mental healthcare: systematic review and meta-analysis of guideline implementation studies
No full textBACKGROUND: Clinical practice guidelines are not easily implemented, leading to a gap between research synthesis and their use in routine care. AIMS: To summarise the evidence relating to the impact of guideline implementation on provider performance and patient outcomes in mental healthcare settings, and to explore the performance of different strategies for guideline implementation. METHOD: A systematic review of randomised controlled trials, controlled clinical trials and before-and-after studies comparing guideline implementation strategies v. usual care, and different guideline implementation strategies, in patients with severe mental illness. RESULTS: In total, 19 studies met our inclusion criteria. The studies did not show a consistent positive effect of guideline implementation on provider performance, but a more consistent small to modest positive effect on patient outcomes. CONCLUSIONS: Guideline implementation does not seem to have an impact on provider performance, nonetheless it may influence patient outcomes positively
Efficacia del litio nella depressione resistente con rischio suicidario. Studio indipendente, pragmatico, multicentrico, di superiorità
No full textBackground: Le linee guida internazionali definiscono “depressione resistente” un quadro clinico di depressione maggiore che non risponde ad almeno due antidepressivi dati sequenzialmente a dosaggio adeguato e per un adeguato periodo di tempo. Nella depressione resistente il riferimento a idee autolesive è piuttosto frequente, fino ad arrivare al suicidio compiuto in circa il 10% dei casi. I dati presenti in letteratura mostrano un effetto benefico del litio nel ridurre i comportamenti autolesivi, ma non sono stati condotti finora trial clinici randomizzati che valutino l’efficacia del litio nel ridurre i gesti auto lesivi e il suicidio in pazienti con depressione resistente.
Metodi: Lo studio LAST è uno studio clinico controllato e randomizzato che prevede di assegnare i soggetti a due opzioni di trattamento: 1) terapia standard con litio versus 2) terapia standard (senza litio). I pazienti verranno seguiti per 12 mesi dopo la randomizzazione e valutati ad ogni mese relativamente all’occorrenza di qualsiasi gesto auto lesivo e al trattamento farmacologico. Un gruppo di lavoro indipendente dal LAST (Independent Adjudicating Committee), in cieco rispetto alla allocazione dei trattamenti, avrà il compito di revisionare tutti gli eventi che potrebbero essere classificati come indicatore di esito primario.
Risultati: Lo studio LAST è una sperimentazione pragmatica, disegnata all’interno della normativa nazionale sulle sperimentazioni finalizzate al miglioramento della pratica clinica quale parte integrante dell'assistenza sanitaria, secondo il Decreto Ministeriale 17/12/2004. Il contratto con l’AIFA per l’esecuzione del progetto di ricerca è stato firmato il 16 gennaio 2009. Il primo Investigators’ Meeting dello studio si è svolto il 6 aprile 2009 ed ha coinvolto gli operatori di oltre 75 Servizi. Alla riunione è stato presentato e discusso il protocollo di studio e sono state delineate le modalità di svolgimento del progetto. Ad oggi, 70 Servizi Psichiatrici Territoriali distribuiti su tutto il territorio nazionale hanno aderito allo studio, che ha ottenuto l’approvazione del Comitato Etico del centro coordinatore il 6 maggio 2009. Le pratiche per i comitati etici dei centri satellite sono state attivate da giugno 2009 in 23 centri, e in 3 centri lo studio è stato già approvato. Inoltre il progetto è stato valutato positivamente per l’accreditamento ECM dalla Regione Veneto.
Discussione: Lo studio LAST si propone, come risultato centrale, di formare gli operatori dei servizi psichiatrici italiani ad affrontare in maniera scientificamente corretta alcune importanti questioni di rilevanza clinica. In questa ottica il criterio della multicentricità diviene il requisito fondamentale anche come elemento di condivisione di un nuovo approccio per affrontare situazioni cliniche ancora “incerte”, dove all’assenza di evidenze si possa rispondere con la pragmaticità del disegno di studio e la semplicità della randomizzazione
- …
