Symptomatic remission in patients with bipolar mania: results from a double-blind, placebo-controlled trial of risperidone monotherapy.
The Journal of clinical psychiatry 2005 Aug 1; 66(8):1016-20
Gopal S S, Steffens D DC, Kramer M ML, Olsen M MK
Johnson & Johnson Pharmaceutical Research & Development, LLC, Titusville, NJ, USA. sgopal2@yahoo.com
BACKGROUND: The purpose of this analysis was to assess rates of symptomatic remission in patients with bipolar mania receiving risperidone in a double-blind, parallel-group, multicenter, placebo-controlled trial conducted in India. METHOD: Two hundred ninety-one adult patients who met DSM-IV criteria for bipolar I disorder manic or mixed episode were randomly assigned to flexible doses of risperidone (1-6 mg/day, N = 146) or placebo (N = 145) for up to 3 weeks. An entry Young Mania Rating Scale (YMRS) score of >or= 20 was required at trial screening and baseline. Remission was defined as achieving and maintaining a YMRS score