Objective: To review clinical trial evidence regarding the efficacy and safety of risperidone for the treatment of bipolar mania.
Data sources: Articles were identified through searches of PubMed (1950-August 2005), EMBASE (1988-August 2005 week 37), and International Pharmaceutical Abstracts (1970-August 2005) databases using the key words risperidone, atypical antipsychotics, and bipolar mania. Additional references were found through review of bibliographies of identified articles. PubMed searches for efficacy and safety were limited to clinical trials.
Study selection and data extraction: Six randomized trials and 6 observational studies of risperidone monotherapy or combination therapy for bipolar mania in adults were selected.
Data synthesis: Randomized, placebo-controlled and observational trials reported that risperidone monotherapy decreases manic symptoms in patients with a moderate severity of mania, as determined by change in Young Mania Rating Scale (YMRS) scores. Adverse effects observed in monotherapy trials included somnolence, extrapyramidal symptoms (EPS), and weight gain. Clinical trials of risperidone in combination with other mood stabilizers (ie, lithium, valproate, carbamazepine, topiramate) also reported decreases in YMRS scores in patients with moderate and severe manic symptoms.
Conclusions: Risperidone monotherapy or adjunctive therapy with other first-line mood stabilizers may be effective for the treatment of acute bipolar mania in adults with moderate severity of mania. The use of risperidone as monotherapy in severe mania or in maintenance treatment remains to be elucidated.