Combination of a Mood Stabilizer With Risperidone or Haloperidol for Treatment of Acute Mania: A Double-Blind, Placebo-Controlled Comparison of Efficacy and Safety

Jul 2, 2002The American journal of psychiatry

Mood stabilizer combined with risperidone or haloperidol for treating sudden mania: a double-blind safety and effectiveness comparison

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Abstract

Risperidone combined with a mood stabilizer showed significant efficacy in reducing mania symptoms compared to placebo.

In a 3-week trial with 156 bipolar disorder patients, risperidone and haloperidol both led to greater reductions in Young Mania Rating Scale scores than placebo.
Discontinuation rates were 49% for placebo, 35% for risperidone, and 53% for haloperidol.
Both risperidone and haloperidol improved mania symptoms in patients regardless of the presence of psychotic features at baseline.
Haloperidol was associated with significantly higher scores on the Extrapyramidal Symptom Rating Scale compared to placebo.
Antiparkinsonian medications were used by 8% of placebo, 17% of risperidone, and 38% of haloperidol patients.

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OBJECTIVE: The study assessed the efficacy and safety of risperidone as an adjunctive agent to mood stabilizers in the treatment of acute mania.

METHOD: This 3-week randomized, double-blind, placebo-controlled study included 156 bipolar disorder patients with a current manic or mixed episode who received a mood stabilizer (lithium or divalproex) and placebo, risperidone, or haloperidol. The primary efficacy measure was the Young Mania Rating Scale. Other assessments used the Brief Psychiatric Rating Scale, the Clinical Global Impression scale, and safety measures.

RESULTS: The trial was discontinued by 25 (49%) of the 51 placebo group patients, 18 (35%) of the 52 risperidone group patients, and 28 (53%) of the 53 haloperidol group patients. Mean modal doses were 3.8 mg/day (SD=1.8) of risperidone and 6.2 mg/day (SD=2.9) of haloperidol. Significantly greater reductions in Young Mania Rating Scale scores at endpoint and over time were seen in the risperidone group and in the haloperidol group, compared with the placebo group. Young Mania Rating Scale total scores improved with risperidone and with haloperidol 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 haloperidol patients than in the placebo patients. Antiparkinsonian medications were received by 8%, 17%, and 38% of patients in the placebo, risperidone, and haloperidol groups, respectively.

CONCLUSIONS: 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.

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Combination of a Mood Stabilizer With Risperidone or Haloperidol for Treatment of Acute Mania: A Double-Blind, Placebo-Controlled Comparison of Efficacy and Safety

Abstract

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