Self-reported quality of life and clinician-rated functioning in mood and anxiety disorders: relationships and neuropsychological correlates.

This study aimed to investigate 1) the relationship between subjective perception of quality of life (QoL) and clinician-rated levels of psychosocial functioning and 2) the relationship of these indicators with neuropsychological performances, in a sample of 117 subjects with mood and anxiety disorders hospitalized for a 4-week psychiatric rehabilitation program. At the beginning of the hospitalization, QoL and clinician-rated functioning were respectively measured by the World Health Organization Quality of Life Assessment-Brief Form (WHOQOL-BREF) and the Global Assessment of Functioning (GAF) scale, and subjects were administered a neuropsychological battery evaluating verbal and visual memory, working memory, attention, visual-constructive ability, language fluency and comprehension. We did not find any association between WHOQOL-BREF and GAF scores and between cognitive impairment and lower QoL or clinician-rated functioning. Our results suggest that 1) the individuals' condition encompasses different dimensions that are not fully captured by using only clinician-rated or self-administered evaluations; 2) the GAF scale seems unable to indicate the cognitive impairments of our subjects and the WHOQOL-BREF does not appear to be influenced by these deficits. Overall, our findings suggest the need of simultaneously use of multiple assessment tools, including objective evaluations of functioning and different measures of QoL, in order to obtain a more complete clinical picture of the patients. This may allow to identify more specific targets of therapeutic interventions and more reliable measures of outcome.

Rationale and design of an independent randomised controlled trial evaluating the effectiveness of aripiprazole or haloperidol in combination with clozapine for treatment-resistant schizophrenia.

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.