Oxcarbazepine in patients with impulsive aggression: a double-blind, placebo-controlled trial.

OBJECTIVE: Impulsive aggression is a common clinically significant symptom, but there are few controlled studies evaluating drug treatment. This study evaluated oxcarbazepine in patients with impulsive aggression and whether diagnosis or other baseline characteristics predict response.
METHOD: Eligible outpatients had clinically significant impulsive aggression, without other psychiatric symptoms clearly requiring treatment. Patients were randomized to oxcarbazepine or placebo, double-blind, for 10 weeks, at a variable dose increasing to 1200 mg/d if tolerated and to 2400 mg/d if aggression persisted. Primary outcome measures were (1) change in a Global Overt Aggression rating derived from the Overt Aggression Scale-Modified and (2) patient-rated global improvement.
RESULTS: Of 48 patients, 24 per group, 9 dropped out due to adverse events, but 45 completed at least 4 weeks on double-blind medication. Analyses showed consistent evidence of benefit from oxcarbazepine, compared with placebo, on both primary efficacy measures and most secondary measures. There were no significant interactions between diagnosis or other baseline characteristics and differential response to oxcarbazepine or placebo.
CONCLUSION: Oxcarbazepine appears to benefit adults with clinically significant impulsive aggression.

RCT Entities:   Population Interventions Outcomes