Italian Psychiatric Services Research Articles

Tolerability of vortioxetine compared to selective serotonin reuptake inhibitors in older adults with major depressive disorder (VESPA): a randomised, assessor-blinded and statistician-blinded, multicentre, superiority trial

Major depressive disorder (MDD) is prevalent and disabling among older adults. Standing on its tolerability profile, vortioxetine might be a promising alternative to selective serotonin reuptake inhibitors (SSRIs) in such a vulnerable population. We conducted a randomised, assessor- and statistician-blinded, superiority trial including older adults with MDD. The study was conducted between 02/02/2019 and 02/22/2023 in 11 Italian Psychiatric Services. Participants were randomised to vortioxetine or one of the SSRIs, selected according to common practice. Treatment discontinuation due to adverse events after six months was the primary outcome, for which we aimed to detect a 12% difference in favour of vortioxetine. The study was registered in the online repository clinicaltrials.gov (NCT03779789). The intention-to-treat population included 179 individuals randomised to vortioxetine and 178 to SSRIs. Mean age was 73.7 years (standard deviation 6.1), and 264 participants (69%) were female. Of those on vortioxetine, 78 (44%) discontinued the treatment due to adverse events at six months, compared to 59 (33%) of those on SSRIs (odds ratio 1.56; 95% confidence interval 1.01-2.39). Adjusted and per-protocol analyses confirmed point estimates in favour of SSRIs, but without a significant difference. With the exception of the unadjusted survival analysis showing SSRIs to outperform vortioxetine, secondary outcomes provided results consistent with a lack of substantial safety and tolerability differences between the two arms. Overall, no significant differences emerged in terms of response rates, depressive symptoms and quality of life, while SSRIs outperformed vortioxetine in terms of cognitive performance. As opposed to what was previously hypothesised, vortioxetine did not show a better tolerability profile compared to SSRIs in older adults with MDD in this study. Additionally, hypothetical advantages of vortioxetine on depression-related cognitive symptoms might be questioned. The study's statistical power and highly pragmatic design allow for generalisability to real-world practice. The study was funded by the Italian Medicines Agency within the "2016 Call for Independent Drug Research".

The Italian psychiatric services organization during the COVID-19 pandemic

The Italian psychiatric services organization during the COVID-19 pandemic

Psychiatric rehabilitation patterns in Italy: Results from the Italian Society of Psychosocial Rehabilitation (SIRP) survey.

Psychiatric rehabilitation can be considered a bidirectional technique, designed to allow patients to achieve their personal target, focusing on the individuals' strengths and challenges related to these targets and also on the community organizations in which they will live them out. Unfortunately, psychiatric rehabilitation is too often not considered a first line treatment. Moreover, rehabilitation has been confused with a generic and rough practice, consisting of extemporary actions and aimless entertainments designed to fill "the time passing". The aim of this study was to increase the knowledge and awareness about the state of the art of different systems of management and funding of psychosocial rehabilitation in the Italian "real-world" rehabilitative settings, using a specifically developed questionnaire. The data obtained are positive for some aspects of the rehabilitation interventions, in particular for the use of validated tools for the evaluation and revision of projects and for the trend to work on a team, even though the scarcity of evidence-based rehabilitation interventions applied in Italian psychiatric services is less encouraging. This survey presents, at least partially, the "real-world" of rehabilitation in Italy so that we can lay the foundations for the definition of an updated, validated and shared network of what is implemented in the context of psychiatric rehabilitation.

Spazi della psichiatria tra passato e presente. Imparare a riflettere sulle srtorie di cura che raccontano

In our perspective, a reflection on education and caring in the psychiatric services cannot ignore their past, where spaces and times of care were completely different from those that characterize the healthcare system today. Many signs, traces, implicit and explicit fragments of that past can be found in current services. According to an “archeological” approach, we believe that those spaces have not been completely overcome and somehow, they are still part of our way of caring in psychiatric services. Hence, what traces of the past are left in those services? How and where can we find them? What should we preserve from the past and what should we overcome? In our work, we will try to find some of the traces and stories that could have contributed to shaping education and care in present day Italian psychiatric services. These developed as isolated spaces and places of confinement and oppression and are transforming into open places and healing spaces, aimed at promoting mental health.

Prevalence and correlates of QTc prolongation in Italian psychiatric care: cross-sectional multicentre study.

In recent years several warnings have been issued by regulatory authorities on the risk of electrocardiogram abnormalities in individuals exposed to psychotropic drugs. As a consequence of these warnings, monitoring of the QT interval corrected for heart rate (QTc) has become increasingly common. This study was conducted to measure the frequency of QTc prolongation in unselected psychiatric patients, and to document the associated factors using a cross-sectional approach. The study was carried out in 35 Italian psychiatric services that are part of the STAR (Servizi Territoriali Associati per la Ricerca) Network, a research group established to produce scientific knowledge by collecting data under ordinary circumstances. During a three-month period, a consecutive unselected series of both in- and out-patients were enrolled if they performed an ECG during the recruitment period and were receiving psychotropic drugs on the day ECG was recorded. During the recruitment period a total of 2411 patients were included in the study. The prevalence of QTc prolongation ranged from 14.7% (men) and 18.6% (women) for the cut-off of 450 ms, to 1.26% (men) and 1.01% (women) for the cut-off of 500 ms. In the multivariate model conducted in the whole sample of patients exposed to psychotropic drugs, female sex, age, heart rate, alcohol and/or substance abuse, cardiovascular diseases and cardiovascular drug treatment, and drug overdose were significantly associated with QTc prolongation. In patients exposed to antipsychotic drugs, polypharmacy was positively associated with QTc prolongation, whereas use of aripiprazole decreased the risk. In patients exposed to antidepressant drugs, use of citalopram, citalopram dose and use of haloperidol in addition to antidepressant drugs, were all positively associated with QTc prolongation. The confirmation of a link between antipsychotic polypharmacy and QTc prolongation supports the current guidelines that recommend avoiding the concurrent use of two or more antipsychotic drugs, and the confirmation of a link between citalopram and QTc prolongation supports the need for routine QTc monitoring. The relatively low proportion of patients with QTc prolongation not only suggests compliance with current safety warnings issued by regulatory authorities, but also casts some doubts on the clinical relevance of QTc prolongation related to some psychotropic drugs.

Special Section: A Memorial Tribute: The VADO Approach in Psychiatric Rehabilitation: A Randomized Controlled Trial

1778 T he results of a recent study of a representative sample of Italian psychiatric services have shown that only 35 percent of patients with schizophrenia who live with their own family are in a psychosocial rehabilitation program and that only 66 percent of these programs ask clients to define their personal goals (1). The most important likely causes are the psychodynamic orientation of many rehabilitation managers, the scarcity of mental health workers trained to teach social and work skills, and the absence of a structured framework to guide rehabilitation practice (2). In 1998 the rehabilitation unit of the Fatebenefratelli Institute of Brescia (Italy), in collaboration with the Italian National Institute of Health and the Institute of Psychiatry of the University of Naples, published a short handbook for the planning and evaluation of rehabilitative interventions in psychiatric centers. The handbook was called VADO—Valutazione delle Abilita e Definizione degli Obiettivi (in English, Skills Assessment and Definition of Goals) (3). It was inspired by the Boston Rehabilitation Center’s approach (4), which identifies patients’ skill deficits and strengths and plans rehabilitative interventions strictly related to patients’ goals. The efficacy of the VADO approach was assessed with a multicenter partially randomized controlled The VADO Approach in Psychiatric Rehabilitation: A Randomized Controlled Trial

Organization of Care and Prevention of Dropout and Burnout in a Psychiatric Team

The closing of access to the psychiatric hospital is the most prominent condition under which Italian psychiatric services must operate because in such a situation they have no back alleys or places to hide their own failures in treatment, care, and rehabilitation. Hence, a solution has to be found for all patients, without selection or with selections that are only relative, i.e., that distinguish among approaches and preferred facilities for various situations, not selections from among patients who can be taken into care and those for whom there is nothing else to do other than deposit them somewhere. This is a condition unknown abroad, and no technique provides for such a situation. Therefore, it is necessary to invent something different; to find out how to work together effectively, today; to avoid reverting tomorrow to psychiatric hospitals, merely changing their name (for example, long stay hospitals or rehabilitation hospitals). In this sense, mental disorders acquire importance not because they are more interesting than neurotic and other types of disorders, but because they are the kind of disorders that can lead to chronicity and disability, which, in turn, reopens the question of the psychiatric hospital. There is, above all, a historical specificity to every psychiatric service. Actually, the psychotic condition and individual and family dynamics are more or less the same everywhere, in every country. Even the principal techniques are now known and relatively widespread among the diverse

Outcome of discharged psychiatric patients after short inpatient treatment: an Italian collaborative study.

This paper presents the results of an Italian multicentre study on the 6-month outcome of psychiatric patients discharged after short-term in-patient treatment from 21 general hospital psychiatric units. Two outcome measures were used: relapses (defined as readmissions for psychiatric treatment or suicide) and community tenure. The data showed, on average, a fairly high relapse rate (43% in 6 months) combined with a good community tenure. The findings are discussed in the light of the heterogeneity in patterns of care provision observed in Italian psychiatric services after the changes introduced by the 1978 Mental Health Act, reported in a previous paper.

A critical appraisal of papers describing Italian psychiatric services.

A critical appraisal of papers describing Italian psychiatric services.

Patterns of care in Italian psychiatric services and psychosocial outcome of schizophrenic patients. A three-year prospective study

Summary141 patients with an ICD-9 diagnosis of schizophrenic psychosis were followed up prospectively for 3 years in 7 Italian centres, representative of the different degrees of application of the psychiatric reform law (Law 180) passed in 1978. It was agreed that each centre would treat the patients according to its routine, and that all contacts with the patients and each intervention performed would be carefully recorded in an ad hoc schedule. The baseline evaluation of psychosocial adjustment was performed by the Disability Assessment Schedule (DAS), and this assessment was then repeated every 6 months during the follow-up period. At the end of this period, the rating on the DAS section 5 was taken as a global measure of patients’ psychosocial outcome. On a stepwise logistic regression analysis, 2 variables were found to be significantly predictive of psychosocial outcome, that is the use of social and/or vocational skills training (associated with a favourable outcome) and the number of days/year of full hospitalization (associated with a poor outcome). Trieste and Arezzo were the only centres in which a significant improvement of the score on some DAS subscales (namely, “occupational role, interest” and “social withdrawal”) was detected. In the whole patient sample, the difference between the final and the baseline score on these subscales correlated significantly with the number/year of outpatient contacts and of home visits. These findings confirm the favourable impact of the community-oriented care provided in some Italian centres on the Psychosocial outcome of schizophrenic patients.

Psychotropic drug utilization and audit in two Italian psychiatric services.

The utilization of psychotropic drugs is a topic of increasing interest. This paper describes a study of psychotropic drug use in two acute psychiatric in-patient services in Cremona, northern Italy. Almost all patients surveyed received one or more psychotropic drugs, and there was evidence of a substantial level of polypharmacy. Women patients were prescribed more psychotropic drugs than the men, while the relationship between drug prescription and psychiatric diagnosis differed between the two services. During the second phase of the study, the medical staff were aware that their prescribing was being monitored. However, this knowledge appeared to have little effect on their patterns of prescribing. The findings of Barton (1978) are thus not supported.

The 'Italian Experience' reconsidered.

Our analysis of the problems of the Italian psychiatric services has drawn a lively correspondence challenging our findings. In September 1985, we undertook a second study tour in Italy. This is now reported, with notes on specific criticisms of the earlier paper.