Comparison of long-term efficacy and safety of risperidone and haloperidol in children and adolescents with autistic disorder
- First Online:
- 295 Downloads
The aim of the study was to investigate safety, efficacy and tolerability of risperidone in comparison with haloperidol in the long-term treatment of autistic disorder.
This was an open-label continuation study of the randomized, double-blind, controlled trial of risperidone and haloperidol study for 12 week in autistic children and adolescents. A total of 28 subjects between 8 and 18 ages with autistic disorder were enrolled to the open label phase of the study. Behavioral rating scales (Clinical Global Impression Scale [CGI-I], Ritvo-Freeman Real Life Rating Scale [RF-RLRS]), Aberrant Behavior Checklist [ABC], Turgay DSM-IV Pervasive Developmental Disorder Rating Scale [TPDDRS]) and safety assessment scales (Extrapyramidal Symptoms Rating Scale [ESRS], UKU-Side Effect Rating Scale) were performed at 12, 16, 20 and 24 weeks, following the 12 week double-blind phase. Risperidone and haloperidol treatments were applied with a once daily dosage regimen as 0.01–0.08 mg/kg/day.
Risperidone led to a significant greater reduction on CGI scale. There was significant improvement on RF-RLRS sensory motor and language subscale and ABC scores in risperidone group. Weight gain was observed more frequently in the haloperidol group at week 24.
These results demonstrate that risperidone is more efficacious and well tolerated than haloperidol in the long-term maintenance treatment of autistic disorder.
Key wordsautistic disorder risperidone haloperidol
- 3.American Psychiatric Association (1994) Diagnostic and statistical manual of mental disorders, 4th edition (DSM-IV). American Psychiatric Association, Washington DCGoogle Scholar
- 6.Arnold LE, Vitiello B, McDougle C, Scahill L, Shah B, Gonzalez NM, Chuang S, Davies M, Hollway J, Aman MG, Cronin P, Koenig K, Kohn AE, McMahon DJ, Tierney E (2003) Parent defined target symptoms respond to risperidone in RUPP autism study: customer approach to clinical trials. J Am Acad Child Adolesc Psychiatry 42 (12):1443–1450PubMedCrossRefGoogle Scholar
- 11.Chouinard G, Ross- Chouinard A, Annable L (1980) Extrapyramidal symptom rating scale. Can J Neurol Sci 7:233Google Scholar
- 13.Cohen IL, Campbell M, Posner D, Small AM, Triebel D, Anderson LT (1980) Behavioral effects of haloperİdol in young autistic children: an objective analysis using a within-subjects reversal design. J Am Acad Child Adolesc Psychiatry 19:665–667Google Scholar
- 19.Guy W (1976) ECDEU assessment manual for psychopharmacology, revised. US Department of Health, Education and Welfare, RockvilleGoogle Scholar
- 26.McCracken JT, McGough J, Shah B, Cronin P, Hong D, Aman MG, Arnold LE, Lindsay R, Nash P, Hollway J, McDougle CJ, Posey D, Swiezy N, Kohn A, Scahill L, Martin A, Koenig K, Volkmar F, Carroll D, Lancor A, Tierney E, Ghuman J, Gonzalez NM, Grados M, Vitiello B, Ritz L, Davies M, Robinson J, McMahon D (2002) Risperidone in children with autism and serious behavioral problems. N Engl J Med (5):314–321Google Scholar
- 29.McDougle CJ, Scahill L, Aman MG, McCracken JT, Tierney E, Davies M, Arnold LE, Posey DJ, Martin A, Ghuman JK, Shah B, Chuang SZ, Swiezy NB, Gonzalez NM (2005) Risperidone for the core symptom domains of autism: results from the study by the Autism Network of the Research Units on Pediatric Psychopharmacology. Am J Psychiatry 162:1142–1148PubMedCrossRefGoogle Scholar
- 32.Ritvo ER, Freeman BJ, Yuwiler A, Geller E, Schroth P, Yokota A, Mason-Brothers A, August GJ, Klykylo W, Leventhal B, Lewis K, Piggott L, Realmuto G, Stubbs EG, Umansky R (1986) Fenfluramine treatment of autism: UCLA collaborative study of 81 patients at nine medical centers. Psychopharmacol Bull 22:133–140PubMedGoogle Scholar
- 33.Scahill L, McCracken J, McDougle CJ, Aman M, Arnold LE, Tierney E, Cronin P, Davies M, Ghuman J, Gonzalez N, Koenig K, Lindsay R, Martin A, McGough J, Posey DJ, Swiezy N, Volkmar F, Ritz L, Vitiello B (2001) Methodological issues in designing a multisided trial of risperidone in children and adolescents with autism. J Child Adolesc Psychopharmacol 11:377–388PubMedCrossRefGoogle Scholar
- 35.Taylor E (1994) Physical treatments. In: Rutter M, Taylor E, Hersov L (eds) Child and adolescent psychiatry, modern approaches, 3rd edn. Great Britain: Bath Press, pp 880–899Google Scholar
- 36.Turgay A (1993) Turgay pervasive developmental disorders scale. Copyright and publication: Integrative Therapy Institute, West BloomfieldGoogle Scholar
- 37.Volkmar FR, Klin A, Cohen DJ (1997) Diagnosis and classification of autism and related conditions. In: Volkmar FR, Cohen DJ (eds) Handbook of autism and pervasive developmental disorders. New York, Wiley pp 5–40Google Scholar