Metabolic syndrome and drug discontinuation in schizophrenia: a randomized trial comparing aripiprazole olanzapine and haloperidol.

OBJECTIVE: To determine whether the prescription of aripiprazole, compared with olanzapine and haloperidol, was associated with a lower frequency of metabolic syndrome (MS) and treatment discontinuation at 1 year. METHOD: Patients were randomly assigned to be treated open-label and according to usual clinical practice with either aripiprazole, olanzapine, or haloperidol and followed up for 1 year. RESULTS: Three hundred out-patients with persistent schizophrenia were recruited in 35 mental health services. The intention-to-treat (ITT) analysis found no significant differences in the rate of MS between aripiprazole (37%), olanzapine (47%), and haloperidol (42%). Treatment discontinuation for any cause was higher for aripiprazole (52%) than for olanzapine (33%; OR, 0.41; P = 0.004), or haloperidol (37%; OR, 0.51; P = 0.030). No significant difference was found between olanzapine and haloperidol. Time to discontinuation for any cause was longer for olanzapine than for aripiprazole (HR, 0.55; P < 0.001). No significant differences were found between haloperidol and aripiprazole, or between olanzapine and haloperidol. CONCLUSION: The prescription of aripiprazole did not significantly reduce the rates of MS, but its treatment retention was worse. Aripiprazole cannot be considered the safest and most effective drug for maintenance treatment of schizophrenia in routine care, although it may have a place in antipsychotic therapy.

Lithium use from 2000 to 2010 in Italy: a population-based study.

INTRODUCTION: Lithium is a highly specific and evidence-supported drug for the acute and maintenance treatment of bipolar disorder. METHODS: The purpose of this study was to calculate the prevalence and incidence of lithium use and to investigate the prescribing patterns of other mood-stabilizing agents in lithium users. We analyzed lithium utilization from 2000 to 2010 in a large area in Italy on the basis of dispensing data drawn from the regional administrative database. For each calendar year those who had at least one recorded dispensation of lithium were defined as lithium users. Those who received more than 4 dispensations per year were defined as lithium-treated. RESULTS: Rates of lithium utilization did not change during the observation period, but the amount of drug prescribed increased as a result of longer treatment and higher doses. The prevalence of use showed an initial increase of 8% (2000-2002), followed by a 13% decrease (2002-2006) and a subsequent rise of 11% (2006-2010). The prevalence of treatment grew by 38% during the whole observation period. The proportion of former lithium users who received other drugs or discontinued any treatment increased from 41% in 2002 to 52% in 2006, and then fell to 40% in 2010. CONCLUSION: The initial decline (2002-2006) and the subsequent rise (2006-2010) of lithium use can be explained by a fall and rise of new prescriptions. This finding together with a similar but opposite change in prescriptions of the other mood-stabilizing agents suggests a temporary change in prescribing attitudes which was subsequently reconsidered.

Validation of the Italian version of the Functioning Assessment Short Test (FAST) for bipolar disorder.

Aim. The Functioning Assessment Short Test (FAST) is a useful instrument for the assessment of overall functioning of people with bipolar disorder, showing good psychometric properties. The aim of this study is to validate the Italian version of FAST. Methods. Translation and back-translation of the original FAST Spanish version were performed. Participants with bipolar disorder (n = 132) and healthy controls (n = 132) completed the FAST as a part of an assessment package including the Montgomery-Asberg Depression Rating Scale and the Young Mania Rating Scale. Internal consistency, inter-rater reliability, construct and discriminant validity were assessed. Results. The FAST Italian version showed good internal consistency, inter-rater reliability and discriminant validity. The cut-off discriminating patients from controls was 15, with a sensitivity of 0.79 and a specificity of 0.80. Principal component analysis with oblique rotation showed factor loadings consistent with the a priori structure of the instrument. Conclusions. This study confirmed the psychometric properties of FAST and extended its generalization and validity to the Italian population.

Schizophrenia trial participation: perceived inclusion barriers and beliefs about antipsychotics.

BACKGROUND: Patient recruitment is the universal rate-limiting factor for randomized controlled trials (RCTs) in all medical specialties. This study examined the opinions on perceived inclusion barriers and beliefs about antipsychotics of a group of psychiatrists participating in a pragmatic RCT on antipsychotic drugs in schizophrenia (the GiSAS trial). METHODS: A survey of all clinicians working in the trial recruiting centers was performed exploring factors associated to the respondents' opinions. RESULTS: Of 465 clinicians, 278 (59.8%) responded to the questionnaire. Respondents (n=278) were mainly influenced by clinical and trial-related barriers (89%). Factors such as work setting and antipsychotic prescription choices appeared to be related to perceived inclusion barriers. Most respondents believed in the superiority of SGAs (62.9%), one-third indicating drug company representatives as the most important source of information; this was related to further optimism towards SGAs. CONCLUSIONS: Respondents were affected mainly by system-related barriers, whereas personal barriers were given less weight. The influence of industry-mediated information could have affected opinions on SGAs and the lack of uncertainty about antipsychotics attitudes towards trial participation.

Outcome of patients dropping out from community-based mental health care: a 6-year multiwave follow-up study.

OBJECTIVE: To test three hypotheses: i) is dropping out of community mental health care due to dissatisfaction? ii) Do those who appropriately interrupt mental health care need any more help? iii) Do those who need treatment continue to receive it? METHOD: A cohort from a Community Mental Health Service in Verona, Italy, was followed up for 6 years, interviewing patients at follow-up who are both in contact and not in contact with the service. RESULTS: The main reason for dropping out was service dissatisfaction. Patients still in contact with the service were more often psychotic. Many patients no longer in contact had mild-to-moderate problems, especially anxiety and depression and some social disability. Patients out of contact rarely sought help from other agencies. CONCLUSION: Comprehensive community mental health services seem to offer good continuity of mental health care to patients with psychosis, but dedicate less attention to patients with less severe problems. Some of these patients will go on experiencing a burden of symptoms and disability, over the years.

Predictors of changes in caregiving burden in people with schizophrenia: a 3-year follow-up study in a community mental health service.

OBJECTIVE: The aims of this study were to measure changes over 3-years in caregiving burden and emotional distress in relatives of people with schizophrenia and to identify factors predicting the levels of caregiving burden. METHOD: A cohort of 51 caregivers of patients with schizophrenia attending the South-Verona Community Mental Health Service was assessed over 3-years with the Involvement Evaluation Questionnaire, European Version. Predictors of caregiving burden included both caregivers' and patients' characteristics and patterns of carer-patient interaction. RESULTS: Baseline levels of family burden were high in worrying and urging domains. Fifty-one per cent of caregivers experienced significant emotional distress. Both overall burden and emotional distress improved. Higher patients' psychopathology, higher numbers of patient-rated needs, patients' lower global functioning and patients' poorer quality of life were found to be related to the severity of family burden. The only significant predictor of caregivers' burden at follow-up was the baseline level of caregivers' burden itself. CONCLUSION: A policy addressing the caring burden of informal caregivers beyond patients' symptoms reduction should be considered.