Fixed-dosed risperidone in mania: an open experimental trial

The purpose of the study was to assess the efficacy and tolerance of risper idone in mania. Fourteen inpatients with a DSM-IV manic episode were treate d with risperidone at a fixed daily dose of 6 mg for 4 weeks. Compliance wa s assured by weekly determinations of serum concentrations of risperidone. Ten out of the 14 patients completed all 4 weeks of treatment, and all of t hese achieved at least a 75% reduction on the Bech-Rafaelsen Mania Scale (M AS). On the other applied measures, a substantial improvement was also seen in most patients, and no worsening in any of the rating scales was observe d in any patient. Five patients continued concomitant treatment with a mood stabilizer. When the results were compared with the results from a similar historic control group treated with the middle-potency typical antipsychot ic zuclopenthixol at a daily dose of 20 mg under the same experimental cond itions, a between group difference in mean percentage change (baseline vers us endpoint) on the MAS was 34.7% (95% confidence interval = 7.9-61.6%) in favour of risperidone. Side-effect profiles were rather similar in the two treatment groups. Despite design limitations, these findings may justify th e conduction of randomized controlled trials to investigate the use of risp eridone in mania. (C) 2001 Lippincott Williams & Wilkins.