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Comparison of long-term efficacy and safety of risperidone and haloperidol in children and adolescents with autistic disorder : An open label maintenance study.

Author(s): Gencer O, Emiroglu FN, Miral S, Baykara B, Baykara A, Dirik E

Affiliation(s): Department of Child and Adolescent Psychiatry, Dokuz Eylul University Faculty of Medicine, 35340, Narlidere, Izmir, Turkey, ozlem.gencer@deu.edu.tr.

Publication date & source: 2007-11-19, Eur Child Adolesc Psychiatry., [Epub ahead of print]

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: These results demonstrate that risperidone is more efficacious and well tolerated than haloperidol in the long-term maintenance treatment of autistic disorder.

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