Risperidone Rapidly Reduces Acute Manic Symptoms
June 18, 2004
NEW YORK (Reuters Health) - In patients with bipolar I disorder experiencing an acute manic episode, monotherapy with risperidone results in a rapid, broad-based reduction in symptoms, researchers report in the June issue of the American Journal of Psychiatry.
In fact, Dr. Robert M. Hirschfeld from the University of Texas Medical Branch at Galveston and colleagues note that "this is the first, large-scale, controlled study that demonstrates that risperidone, when used alone, significantly reduces the manic symptoms associated with bipolar I disorder."
The researchers came to this conclusion after randomly assigning 134 such patients to flexible-dose risperidone (1-6 mg/day) and 125 to placebo for 3 weeks.
In the risperidone group there was a significantly greater improvement in mean scores on the Young Mania Rating Scale (-10.6) than in the placebo group (-4.8). Furthermore, significant between-group differences were seen as early as 3 days after the start of treatment and continued for the course of the study.
A post hoc analysis indicated that 38% of risperidone-treated compared with 20% of placebo-treated patients attained remission, defined as a Young Mania Rating Scale score of 12 or less.
Risperidone also produced significantly greater improvements on the Clinical Global Impression severity rating scale and the Montgomery-Asberg Depression Rating Scale.
At the end of the trial, 53.5% of risperidone-treated patients were judged to be "not ill, very mildly ill, or mildly ill," compared with 25.8% of placebo-treated subjects.
The researchers conclude that the agent was well tolerated, and "has an important role in the treatment of patients with bipolar mania."
Am J Psychiatry 2004;161:1057-1065.
Management of Serious Mental Illness