The effectiveness of long-acting injectable risperidone in a population of psychiatric out-patients: 1-year naturalistic study.

OBJECTIVE: A naturalistic, prospective study analyzed the effectiveness of long-acting injectable risperidone (LAIR) in psychotic outpatients. METHODS: All outpatients (n = 53), affected by Schizophrenia and other Psychotic Disorders, who have begun LAIR at the Mental Health Service of Modena from December 1, 2005 to December 1, 2006, were collected. EXCLUSION CRITERIA: concomitant oral antipsychotic therapy at the 12th weeks (n = 16 patients) and treatment discontinuation (n = 12). The reasons of drop-out were analyzed. Clinical and demographic characteristics of outpatients (n = 25), motivations, implementation and adverse effects of LAIR treatment were evaluated. MAIN OUTCOME: the improvement of symptoms (25% reduction of BPRS and CGI-S scale score from baseline) and functioning level (50% increase of GAF scale score from baseline) at 6th (T6) and 12th (T12) month of LAIR therapy. Secondary outcome: reduction of the hospitalization days during the 1-year LAIR treatment in comparison to the previous year ones of the same patients. RESULTS: The final BPRS, CGI-S and GAF scores both at T6 and T12 showed a statistically significant difference from baseline (p < 0.0001, t-test). The frequency of improved patients in BPRS, CGI-S and GAF scales were 60%, 68%, 52% at T6, and 72%, 54%, 56% at T12, respectively. Side effects were represented by weight increase (4%), orthostatic hypotension (8%) and EPS (4%). The hospitalization days were statistically significant reduced during the 1-year LAIR treatment in comparison to the previous year ones (p < 0.05, t-test). CONCLUSION: Our data, limited by the small sample and the naturalistic methodology, suggest that 1-year LAIR treatment may be effective and safe.

Aripiprazole: effectiveness and safety under naturalistic conditions.

A retrospective study was conducted to examine aripiprazole's effectiveness and safety in a naturalistic treatment setting in both inpatients and outpatients affected by schizophrenia and other psychotic disorders. All patients with schizophrenia, schizoaffective and delusional disorders, and schizoid and schizotypal personality disorders treated with aripiprazole from March 1, 2005, to March 1, 2006, in the authors' community mental health service were divided into outpatient (n=26) and inpatient (n=17) groups; the average treatment periods were 204 days and 25 days, respectively. Effectiveness was evaluated by improvement of symptoms (a 25% reduction of Brief Psychiatric Rating Scale [BPRS] score from baseline) and functioning level (a 50% increase of Global Assessment of Functioning [GAF] scale score from baseline), as well as dropout rate. Adverse effects and their impact on treatment course were also evaluated. The final scores of the 2 scales showed a statistically significant difference from baseline (BPRS: p<.001 in the 2 groups; GAF: p<.005 in inpatients, p<.001 in outpatients). The average improvements in BPRS and GAF were 54% and 35%, respectively, in outpatients and 71% and 71% in inpatients. Side effects included anxiety, psychomotor agitation, insomnia, and psychotic symptom worsening. The dropout rate was 24% in inpatients and 23% in outpatients, largely because of the aforementioned side effects. The data, though limited by the small sample and naturalistic methodology, suggest that aripiprazole may be effective for both long- and short-term treatment, with a greater improvement among inpatients and a similar dropout rate between groups.