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 | | | | | | | Risperidone add-on for therapy acute mania (2)
Authors: Yatham et al.
Title: Mood stabilizers plus risperidone or placebo in the treatment of acute mania.
Reference: Br J Psychiatry 2003;182:141-7.
Purpose: To determine the efficacy of risperidone in combination with a mood stabiliser in patients with acute mania.
Study design: Randomized, double-blinded, placebo-controlled, 3-week, multicenter trial.
Follow up: None specified.
Patients: 151 bipolar I patients (75 risperidone, 76 placebo) taking a mood stabilizer (lithium, divalproex, or carbamazepine) with acute mania (YMRS > 20).
Treatment: Risperidone at an initial dose of 2 mg/day that could be adjusted within the range of 1–6 mg/day.
Results: No significant decrease in mania scores at the endpoint was observed in patients treated with risperidone compared with placebo (14.5 versus 10.3 points, p=0.089). Other measures (improvement at week 1, percent of responders at endpoint) were significantly in favor of risperidone. Symptoms of EPS were reported in 21% of patients treated with risperidone compared with 8% of patients treated with placebo, p = 0.013).extra-pyramidal symptoms Young Mania Rating Scale Young Mania Rating Scale
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