Efficacy of Aripiprazole Versus Placebo in the Reduction of Aggressive and Aberrant Behavior in Autistic Children

Summary

Hypothesis: (1) Aripiprazole treatment will be superior to placebo in reducing aggression and irritability in autistic individuals as shown by reductions in the Aberrant Behavior Checklist-irritability subscale. (2) Aripiprazole treatment will be superior to placebo in the acute treatment of global autism severity. The purpose of this study is to examine the possible benefit of the medication Aripiprazole in autistic individuals.

Timeline

Start

2006-05

Primary completion

2009-11

Completion

2009-11

Publications

• Background Aman M, Smgh N, Stewart A, Field C. The aberrant behavior checklist: a behavior rating scale for the assessment of treatment effects.Am J Ment Defic, 1985a;89(5):485 491 Campbell M, et al, Neuroleptic related dyskinesias in autistic children: a prospective longitudinal study, J Am Acad Child Adolesc Psychiatry 1997; 36(6): 835 43. Fomboime E. The epidemiology of autism: a review. Psychological Medicine, 1999; 29:769 786. Guy W. ECDEU assessment manual for psychopharmacology. Revised. NTMH Publication DHEW Publ No (adm.) 76 388. Bethesda, MD: National Institute of Mental Health, 1976; 217 222. McDougle CJ, Holmes JP, Bronson MR, Anderson GM, Volkmar FR, Price LH, Cohen DJ. Risperidone treatment of children and adolescents with pervasive developmental disorders: a prospective open label study. J Am Acad Child Adolesc Psychiatry. 1997 May;36(5):685 93. Stahl SM. Dopamine system stabilizers, aripiprazole, and the next generation of antipsychotics, J Clin Psychiatry. 2001;62(l1).
• Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.

Drugs

Indications