Risperidone augmentation for treatment-resistant aggression in attention-deficit/hyperactivity disorder: a placebo-controlled pilot study.
OBJECTIVE
To evaluate the effects of risperidone augmentation for treatment-resistant aggression in children with attention-deficit/hyperactivity disorder (ADHD).


METHODS
Twenty-five children (ages 7-12 years) with attention-deficit/hyperactivity disorder (ADHD) and significant aggressive behaviors were randomized to risperidone or placebo for 4 weeks for this double-blind study. Subjects were already in treatment with a constant dose of psychostimulant medication. The primary efficacy measure was change from baseline in the Children's Aggression Scale-Parent (CAS-P) and -Teacher (CAS-T) total scores.


RESULTS
The mean risperidone dose at endpoint was 1.08 mg/day. For the CAS-P total score, a significant difference was found (chi(1)(2) = 4.30, p < .05) with 100% of risperidone subjects improving by more than 30% from baseline to endpoint, whereas only 77% of the placebo group reported a similar response. No differences were found on the CAS-T total score. For the CAS-P and CAS-T, no significant interaction was found between treatment group and time. Rates of adverse events did not differ significantly between groups.


CONCLUSIONS
Risperidone treatment appears to be well tolerated and modestly effective when used in combination with psychostimulants for treatment-resistant aggression in children with ADHD.
Armenteros
Jorge L
JL
Dr. Armenteros is in private practice, Coral Gables, FL; and Dr. Lewis and Ms. Davalos are with the University of Miami Miller School of Medicine. Electronic address: armenterosmd@bellsouth.net.
Lewis
John E
JE
Dr. Armenteros is in private practice, Coral Gables, FL; and Dr. Lewis and Ms. Davalos are with the University of Miami Miller School of Medicine.
Davalos
Marisabel
M
Dr. Armenteros is in private practice, Coral Gables, FL; and Dr. Lewis and Ms. Davalos are with the University of Miami Miller School of Medicine.
D000374:Aggression / Q000523:psychology*; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis / Q000188:drug therapy / Q000523:psychology; D000697:Central Nervous System Stimulants / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D004351:Drug Resistance; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000627:therapeutic use*; D010865:Pilot Projects; D018967:Risperidone / Q000008:administration & dosage / Q000627:therapeutic use*; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires
D014150:Antipsychotic Agents; D000697:Central Nervous System Stimulants; D008774:Methylphenidate; D018967:Risperidone