RESUMEN
BACKGROUND: One third to two thirds of people with schizophrenia have persistent psychotic symptoms despite clozapine treatment. Under real-world circumstances, the need to provide effective therapeutic interventions to patients who do not have an optimal response to clozapine has been cited as the most common reason for simultaneously prescribing a second antipsychotic drug in combination treatment strategies. In a clinical area where the pressing need of providing therapeutic answers has progressively increased the occurrence of antipsychotic polypharmacy, despite the lack of robust evidence of its efficacy, we sought to implement a pre-planned protocol where two alternative therapeutic answers are systematically provided and evaluated within the context of a pragmatic, multicentre, independent randomised study. METHODS/DESIGN: The principal clinical question to be answered by the present project is the relative efficacy and tolerability of combination treatment with clozapine plus aripiprazole compared with combination treatment with clozapine plus haloperidol in patients with an incomplete response to treatment with clozapine over an appropriate period of time. This project is a prospective, multicentre, randomized, parallel-group, superiority trial that follow patients over a period of 12 months. Withdrawal from allocated treatment within 3 months is the primary outcome. DISCUSSION: The implementation of the protocol presented here shows that it is possible to create a network of community psychiatric services that accept the idea of using their everyday clinical practice to produce randomised knowledge. The employed pragmatic attitude allowed to randomly allocate more than 100 individuals, which means that this study is the largest antipsychotic combination trial conducted so far in Western countries. We expect that the current project, by generating evidence on whether it is clinically useful to combine clozapine with aripiprazole rather than with haloperidol, provides physicians with a solid evidence base to be directly applied in the routine care of patients with schizophrenia.
Asunto(s)
Antipsicóticos/uso terapéutico , Clozapina/uso terapéutico , Resistencia a Medicamentos , Haloperidol/uso terapéutico , Piperazinas/uso terapéutico , Quinolonas/uso terapéutico , Esquizofrenia/tratamiento farmacológico , Psicología del Esquizofrénico , Aripiprazol , Protocolos Clínicos , Quimioterapia Combinada , Regulación Gubernamental , Humanos , Italia , Estudios Prospectivos , Proyectos de Investigación/legislación & jurisprudencia , Resultado del TratamientoRESUMEN
AIMS: We wanted to investigate to what extent and in what characteristics the patients cared in the psychiatric residential facilities (RF) were similar to those in the day-centres (DC), and whether 6-month improvements in the two settings were comparable. METHODS: We described 141 patients admitted to the RF and 180 in DC of three mental health service networks in Milan and near Milan. They were evaluated again after six months. RESULTS: In both groups, we identified subgroups of more intensive treatment: 45% of those in residential treatment were in high intensity rehabilitation facilities, and those who followed a residential program of >12 hours/week were 53%. The mean duration of treatment in the residential treatment was 40 months (SD 55.7) and in DC 49.6 months (49.3). The two groups differed in the overall scores of the HoNOS, but differences emerged in the subscales relative to daily life activities and living conditions. Among those in RF, about half had a house, versus 99% among those in DC. After six months, clinically significant modifications were small in both groups. CONCLUSIONS: Residential patients had more needs than DC patients. It is possible that some of the residential patients might be treated with intensive DC program, but the absence of a home for the majority of residential facilities patients makes this unlikely.
Asunto(s)
Centros Comunitarios de Salud Mental/organización & administración , Centros de Día/organización & administración , Femenino , Humanos , Estudios Longitudinales , MasculinoRESUMEN
This observational study investigated the outcomes of a community-based rehabilitation program that was designed to enhance social functioning, social inclusion, and well-being of people with mental illness who were considered treatment failures by psychiatric professionals in Italy. Of the 144 patients who entered the program, 131 started the program and 109 completed either 12 or 18 months of treatment. Illness severity was assessed by the Health of the Nation Outcome Scales (HoNOS) and social functioning by the Social and Occupational Functioning Assessment Scale (SOFAS). On the HoNOS, 33% of patients showed reliable change. On the SOFAS, 27% showed reliable change, although the change was substantial for few patients. Over time, patients showed moderate but significant improvements on the HoNOS and SOFAS. The HoNOS subscales concerning interpersonal relationships and social inclusion showed significant change. Very isolated people with mental illness gained some advantages from this rehabilitation program that was based on a close relationship with a key worker; however, the program duration may have been inadequate to produce substantial changes. Our findings warrant further research based on controlled studies.