Office-based post-marketing surveillance study on the influence of long term therapy with aripiprazole in patients with schizophrenia

Objective: The objective of this post-marketing surveillance study was to document safety and efficacy of the treatment with aripiprazole in a large schizophrenia outpatient population. Methods: The efficacy was evaluated by the change of psychopathometric variables (Clinical Global Impressions (CGI), Generic Health Outcomes Survey (SF-12)) observed after a 3- to 12-month (maximum) treatment on a routine basis. This post-marketing surveillance study included patients with schizophrenia eligible for treatment with aripiprazole according to their physicians' judgement. 1096 patients were enrolled in 408 centres (neurologists/psychiatrists in offices/private practices) in Germany. Results: The results support the sustained positive long-term effects of aripiprazole in the treatment of patients with schizophrenia. Mean treatment duration was 9,7 months. More than half of the patients received the 15mg dose, and 37% received 10mg. An overall improvement in the CGI was observed as early as week 4 after initiation of antipsychotic treatment. At the endpoint, 80% of the patients showed a minimal improvement at least. Over the study period, the mean SF-12 score increased for both, the physical and the psychological subscale. Further results are currently in analysis and will be presented at the congress. Conclusion: In general, safety and efficacy variables were similar to previously published data from short- and long-term aripiprazole trials.

This study was supported by Bristol-Myers Squibb