Fixed-dosed risperidone in mania: an open experimental trial

The purpose of the study was to assess the efficacy and tolerance of risperidone in mania. Fourteen inpatients with a DSM-IV manic episode were treated with risperidone at a fixed daily dose of 6 mg for 4 weeks. Compliance was assured by weekly determinations of serum concentrations of risperidone. Ten out of the 14 patients completed all 4 weeks of treatment, and all of these achieved at least a 75% reduction on the Bech-Rafaelsen Mania Scale (MAS). On the other applied measures, a substantial improvement was also seen in most patients, and no worsening in any of the rating scales was observed 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 antipsychotic zuclopenthixol at a daily dose of 20 mg under the same experimental conditions, a between group difference in mean percentage change (baseline versus 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 the conduction of randomized controlled trials to investigate the use of risperidone in mania.