Risperidone Plus Mood Stabilizer Helpful in Acute Mania

Laurie Barclay, MD

July 17, 2002

July 18, 2002 — Risperidone combined with a mood stabilizer was more effective in acute mania than the mood stabilizer alone and as effective as the combination of haloperidol and a mood stabilizer, according to the results of a double-blind, placebo-controlled trial reported in the July issue of the American Journal of Psychiatry. Compared with the haloperidol combination, the risperidone combination had significantly fewer adverse effects and extrapyramidal symptoms.

"To our knowledge, this study provides the first controlled comparison of a typical and atypical antipsychotic in the treatment of mania," write Gary S. Sachs, MD, from Massachusetts General Hospital in Boston, and colleagues.

In this three-week study, 156 bipolar disorder patients with a current manic or mixed episode were randomized to treatment with a mood stabilizer (lithium or divalproex) and placebo, risperidone, or haloperidol. Mean modal doses were 3.8 mg/day (SD=1.8) of risperidone and 6.2 mg/day (SD=2.9) of haloperidol. Nearly half of patients in the placebo group (25 [49%] of 51) discontinued the trial, as did 18 (35%) of 52 patients in the risperidone group and 28 (53%) of 53 patients in the haloperidol group.

Compared with the placebo group, the risperidone group and the haloperidol group had significantly greater reductions in Young Mania Rating Scale scores at endpoint and over time, both in patients with psychotic features and in those without psychotic features at baseline. Extrapyramidal Symptom Rating Scale total scores at endpoint were significantly higher in the patients receiving haloperidol than in those given placebo. Antiparkinsonian medications were used by 8%, 17%, and 38% of patients treated with placebo, risperidone, and haloperidol, respectively.

"Risperidone plus a mood stabilizer was more efficacious than a mood stabilizer alone, and as efficacious as haloperidol plus a mood stabilizer, for the rapid control of manic symptoms and was well tolerated," the authors write. "The combination may also be associated with the need for lower blood levels of the mood stabilizer, thus diminishing dose-related side effects associated with these agents."

The Janssen Research Foundation supported this study.

Am J Psychiatry. 2002;159:1146-1154

Reviewed by Gary D. Vogin, MD

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