Authors: Vieta, et al.
Title: Risperidone in the treatment of manic or mixed episodes of bipolar disorder.
Reference: Poster presented at the 41st ACNP annual meeting, December 2002.
Purpose: To determine the efficacy of risperidone monotherapy in the acute treatment of patients with manic or mixed episodes.
Study design: Randomized, double-blinded, placebo-controlled, 3-week, multicenter trial conducted in India.
Follow up: none specified.
Patients: 290 bipolar I inpatients (146 risperidone, 144 placebo) with a manic or mixed episode (YMRS >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 week 1 onwards. At the endpoint, response rates (>50% reduction in YMRS) were 73% for risperidone and 36% for placebo (p < 0.001). Symtoms of EPS were reported in 35% of risperidone-treated patients versus 6% of placebo-treated patients.