Authors: Eerdekens, et al.
Title: Risperidone monotherapy in acute bipolar mania.
Reference: Poster presented at the 4th International Forum on Mood and Anxiety Disorders, November 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.
Follow up: 9 weeks open-label continuation following a 3-week acute phase.
Patients: 438 bipolar I inpatients (154 risperidone, 144 haloperidol, 140 placebo) with a manic episode (YMRS >20 and MADRS <20).
Treatment: Risperidone flexible dose (1–6 mg/day), haloperidol flexible dose (2 –12 mg/day), or placebo.
Results: Risperidone and haloperidol produced significantly greater improvements in YMRS scores compared with placebo from week 1 onwards. At the endpoint, response rates (>50% reduction in YMRS) were 48% for risperidone, 47% for haloperidol, and 33% for placebo (p < 0.05 versus placebo for both active treatments). Symptoms of EPS were reported in 17% of risperidone-treated patients versus 40% of haloperidol-treated patients.