Authors: Hirschfeld et al.
Title: Rapid antimanic effect of risperidone monotherapy: a 3-week multicenter, double-blind, placebo-controlled trial.
Reference: Poster presented at the 156th APA annual meeting, May 2003.
Purpose: To determine the efficacy of risperidone monotherapy in the acute treatment of patients with a manic episode.
Study design: Randomized, double-blinded, placebo-controlled, 3-week, multicenter trial conducted in the USA.
Follow up: 9 weeks (open label).
Patients: 259 bipolar I inpatients (134 risperidone, 125 placebo) with a manic episode (YMRS >20 and MADRS <20)
Treatment: Risperidone flexible dose (1–6 mg/day) or placebo monotherapy.
Results: Risperidone produced significantly greater improvements in YMRS scores compared with placebo from day 3 onwards. At the endpoint, response rates (>50% reduction in YMRS) were 43% for risperidone and 24% for placebo (p < 0.01). Symptoms of EPS were reported in 16% of risperidone-treated patients versus 5% of placebo-treated patients.