Risperidone: an open-label, observational study of the efficacy, tolerability, and prescribing behavior in acutely exacerbated patients with schizophrenia.

OBJECTIVE: Efficacy of atypical antipsychotic in acute schizophrenic episodes is still in debate. This study evaluated treatment practices over 7 years of initial treatment with oral risperidone in acutely exacerbated patients with schizophrenia and in a subgroup of highly agitated, tense, and aggressive patients. Additionally, the study investigated the efficacy and tolerability of risperidone in routine clinical practice. METHODS: In a prospective, multicenter, observational trial from 1996 to 2002, patients with schizophrenia experiencing acute symptom exacerbations were treated with risperidone within 24 hours of inpatient admission. Patients with a total score of > or =15 points on the agitation subscale of the Positive and Negative Syndrome Scale (PANSS) were defined as highly agitated. Efficacy measures were carried out with a modified PANSS, the Clinical Global Impression (CGI) and the Brief Psychiatric Rating Scale (BPRS). RESULTS: A total of 1625 patients were evaluated. Despite prescription of decreasing risperidone dosages over 7 years, efficacy was maintained and tolerability improved significantly. Significant symptom relief occurred in all patients and was more pronounced in the subgroup of highly agitated patients (n = 256; P < 0.001 for PANSS, BPRS, and CGI). At Week 6, the mean daily dosage of risperidone was 4.8 mg in the highly agitated patients and 4.7 mg in the remaining patients, and more than 55% of all patients were receiving risperidone as monotherapy. CONCLUSIONS: Prescribing patterns with risperidone in patients with acutely exacerbated schizophrenia, including highly agitated patients, changed with the experience gained with this compound. In routine clinical practice in this indication, risperidone was found to be effective and well tolerated.