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 < or = 0.05) on the ABC for patients who initially received risperidone and a decrease of 11.3 points (P < or = 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.
RCT Entities:
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 < or = 0.05) on the ABC for patients who initially received risperidone and a decrease of 11.3 points (P < or = 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.
Authors: C J McDougle; J P Holmes; M R Bronson; G M Anderson; F R Volkmar; L H Price; D J Cohen Journal: J Am Acad Child Adolesc Psychiatry Date: 1997-05 Impact factor: 8.829
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