Tags

Type your tag names separated by a space and hit enter

Aripiprazole in the treatment of irritability in children and adolescents with autistic disorder.
Pediatrics. 2009 Dec; 124(6):1533-40.Ped

Abstract

OBJECTIVE

The objective of this study was to evaluate short-term efficacy and safety of aripiprazole in the treatment of irritability in children and adolescents with autistic disorder who were manifesting behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these.

METHODS

This 8-week, double-blind, randomized, placebo-controlled, parallel-group study was conducted of children and adolescents (aged 6-17 years) with autistic disorder. Patients were randomly assigned (1:1) to flexibly dosed aripiprazole (target dosage: 5, 10, or 15 mg/day) or placebo. Efficacy outcome measures included the Aberrant Behavior Checklist irritability subscale and the Clinical Global Impression-Improvement score (CGI-I). Safety and tolerability were also assessed.

RESULTS

Ninety-eight patients were randomly assigned to receive placebo (n = 51) or aripiprazole (n = 47). Mean improvement in Aberrant Behavior Checklist irritability subscale score was significantly greater with aripiprazole than with placebo from week 1 through week 8. Aripiprazole demonstrated significantly greater global improvements than placebo, as assessed by the mean CGI-I score from week 1 through week 8; however, clinically significant residual symptoms may still persist for some patients. Discontinuation rates as a result of adverse events (AEs) were 10.6% for aripiprazole and 5.9% for placebo. Extrapyramidal symptom-related AE rates were 14.9% for aripiprazole and 8.0% for placebo. No serious AEs were reported. Mean weight gain was 2.0 kg on aripiprazole and 0.8 kg on placebo at week 8.

CONCLUSIONS

Aripiprazole was efficacious in children and adolescents with irritability associated with autistic disorder and was generally safe and well tolerated.

Authors+Show Affiliations

Bristol-Myers Squibb, 5 Research Parkway, Wallingford, Connecticut 06492, USA. randall.owen@bms.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19948625

Citation

Owen, Randall, et al. "Aripiprazole in the Treatment of Irritability in Children and Adolescents With Autistic Disorder." Pediatrics, vol. 124, no. 6, 2009, pp. 1533-40.
Owen R, Sikich L, Marcus RN, et al. Aripiprazole in the treatment of irritability in children and adolescents with autistic disorder. Pediatrics. 2009;124(6):1533-40.
Owen, R., Sikich, L., Marcus, R. N., Corey-Lisle, P., Manos, G., McQuade, R. D., Carson, W. H., & Findling, R. L. (2009). Aripiprazole in the treatment of irritability in children and adolescents with autistic disorder. Pediatrics, 124(6), 1533-40. https://doi.org/10.1542/peds.2008-3782
Owen R, et al. Aripiprazole in the Treatment of Irritability in Children and Adolescents With Autistic Disorder. Pediatrics. 2009;124(6):1533-40. PubMed PMID: 19948625.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Aripiprazole in the treatment of irritability in children and adolescents with autistic disorder. AU - Owen,Randall, AU - Sikich,Linmarie, AU - Marcus,Ronald N, AU - Corey-Lisle,Patricia, AU - Manos,George, AU - McQuade,Robert D, AU - Carson,William H, AU - Findling,Robert L, PY - 2009/12/2/entrez PY - 2009/12/2/pubmed PY - 2009/12/31/medline SP - 1533 EP - 40 JF - Pediatrics JO - Pediatrics VL - 124 IS - 6 N2 - OBJECTIVE: The objective of this study was to evaluate short-term efficacy and safety of aripiprazole in the treatment of irritability in children and adolescents with autistic disorder who were manifesting behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these. METHODS: This 8-week, double-blind, randomized, placebo-controlled, parallel-group study was conducted of children and adolescents (aged 6-17 years) with autistic disorder. Patients were randomly assigned (1:1) to flexibly dosed aripiprazole (target dosage: 5, 10, or 15 mg/day) or placebo. Efficacy outcome measures included the Aberrant Behavior Checklist irritability subscale and the Clinical Global Impression-Improvement score (CGI-I). Safety and tolerability were also assessed. RESULTS: Ninety-eight patients were randomly assigned to receive placebo (n = 51) or aripiprazole (n = 47). Mean improvement in Aberrant Behavior Checklist irritability subscale score was significantly greater with aripiprazole than with placebo from week 1 through week 8. Aripiprazole demonstrated significantly greater global improvements than placebo, as assessed by the mean CGI-I score from week 1 through week 8; however, clinically significant residual symptoms may still persist for some patients. Discontinuation rates as a result of adverse events (AEs) were 10.6% for aripiprazole and 5.9% for placebo. Extrapyramidal symptom-related AE rates were 14.9% for aripiprazole and 8.0% for placebo. No serious AEs were reported. Mean weight gain was 2.0 kg on aripiprazole and 0.8 kg on placebo at week 8. CONCLUSIONS: Aripiprazole was efficacious in children and adolescents with irritability associated with autistic disorder and was generally safe and well tolerated. SN - 1098-4275 UR - https://www.unboundmedicine.com/medline/citation/19948625/Aripiprazole_in_the_treatment_of_irritability_in_children_and_adolescents_with_autistic_disorder_ L2 - http://pediatrics.aappublications.org/cgi/pmidlookup?view=long&pmid=19948625 DB - PRIME DP - Unbound Medicine ER -