Short- and long-term efficacy and safety of risperidone in adults with disruptive behavior disorders.
BACKGROUND
Function in society can be severely affected by disruptive behaviors in adults.


OBJECTIVE
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.


CONCLUSIONS
Risperidone is efficacious and well tolerated in managing disruptive behavior disorders in adults with intellectual disability.
Gagiano
Carllo
C
Westdene Research Center, PO Box 29788, Danhof, 9310, South Africa. cttrust@intekom.co.za
Read
Stephen
S
Thorpe
Lilian
L
Eerdekens
Mariëlle
M
Van Hove
Ilse
I
D000293:Adolescent; D000328:Adult; D019958:Attention Deficit and Disruptive Behavior Disorders / Q000188:drug therapy* / Q000523:psychology*; D006970:Disorders of Excessive Somnolence / Q000139:chemically induced; D004311:Double-Blind Method; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D018967:Risperidone / Q000008:administration & dosage* / Q000009:adverse effects*
D018967:Risperidone