Short- and long-term efficacy and safety of risperidone in adults with disruptive behavior disorders

Rationale: Function in society can be severely affected by disruptive behaviors in adults. Objectives: To examine the efficacy and safety of risperidone in the treatment of disruptive behavior disorders in intellectually disabled adults. Methods: Intellectually disabled patients with disruptive behavior disorder were randomly assigned to receive risperidone ( n= 39) in a flexible dosage ranging from 1 to 4 mg/day ( mean dosage, 1.45 +/- 0.08 mg/day) or placebo ( n= 38) for 4 weeks of double- blind treatment. Efficacy at endpoint was measured primarily by using the Aberrant Behavior Checklist (ABC); secondary efficacy measures included the Behavior Problems Inventory and Clinical Global Impressions scales. After this 4-week period, patients could enter open-label treatment with risperidone for 48 weeks. Results: Risperidone was well tolerated, and patients treated with risperidone demonstrated significantly greater improvement at endpoint on the ABC than those who received placebo [- 27.3 points (52.8% improvement) versus - 14.9 points (31.3% improvement); P= 0.036] and also improved on Behavior Problems Inventory and Clinical Global Impressions ratings. Over the 48-week, open-label follow-up period, there was a further decrease of 6.3 points ( P= 0.05) on the ABC for patients who initially received risperidone and a decrease of 11.3 points ( P= 0.05) for patients who initially received placebo and were switched to open-label risperidone. These results were achieved with a mean modal dosage of 1.8 mg/day. Conclusion: Risperidone is efficacious and well tolerated in managing disruptive behavior disorders in adults with intellectual disability.