Authors: Sachs, et al.
Title: Combination of a mood stabilizer with risperidone or haloperidol for treatment of acute mania: a double-blind, placebo-controlled comparison of efficacy and safety.
Reference: Am J Psychiatry 2002;159:1146-54.
Purpose: To determine the efficacy of risperidone as combination therapy with lithium or valproate in the acute manic phase of bipolar disorder.
Study design: Randomized, double-blinded, placebo-controlled, 3-week, multicenter trial.
Follow up: None specified.
Patients: 156 bipolar I inpatients (52 risperidone, 53 haloperidol, 51 placebo) with a manic or mixed episode (YMRS >20).
Treatment: Risperidone flexible dose (1–6 mg/day), haloperidol flexible dose (2–12 mg/day), or placebo add-on to open-label lithium or valproate treatment.
Results: Significantly greater improvements in YMRS scores at the endpoint were observed in patients treated with risperidone or haloperidol compared with placebo, with no significant differences observed between the two active treatments. At the endpoint, response rates (CGI rating of much or very much improved) were 53% for risperidone, 50% for haloperidol, and 30% for placebo (p < 0.05 compared with placebo for both active treatments). Symptoms of EPS were reported in 13% of risperidone patients versus 28% of haloperidol patients and 4% of placebo patients.