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Aripiprazole in the treatment of irritability in pediatric patients (aged 6-17 years) with autistic disorder: results from a 52-week, open-label study.
J Child Adolesc Psychopharmacol. 2011 Jun; 21(3):229-36.JC

Abstract

AIM

To report the long-term efficacy of aripiprazole in the treatment of irritability in children and adolescents (ages 6-17 years) with autistic disorder.

METHODS

This was a 52-week, open-label, flexible-dose (2-15 mg/day) study of aripiprazole for the treatment of children and adolescents with irritability associated with autistic disorder. Eligible subjects were enrolled from two 8-week randomized trials or were enrolled as de novo subjects. "Prior aripiprazole" subjects had received treatment with aripiprazole for 8 weeks before entering this study. Evaluation of efficacy, a secondary objective after evaluation of safety and tolerability in this study, was conducted using the caregiver-rated Aberrant Behavior Checklist-Irritability subscale and the clinician-rated Clinical Global Impression-Improvement score.

RESULTS

Three hundred thirty subjects received treatment (de novo, n = 86; prior aripiprazole, n = 174; prior placebo, n = 70) and 199 subjects (60.3%) completed 52 weeks of treatment. At their last study visit, 38.2% of subjects were receiving concomitant central nervous system medications (commonly antidepressants, 13.4%; psychostimulants, 11.5%; antiepileptics, 5.9%). At week 52 (observed cases data set), the mean change from baseline in Aberrant Behavior Checklist Irritability subscale scores was -8.0 in de novo subjects and -6.1 in prior placebo subjects; prior aripiprazole subjects maintained symptom improvement that was achieved with treatment in the prior study. At endpoint, the majority of subjects had a Clinical Global Impressions-Improvement score of 2 (much improved) or 1 (very much improved).

CONCLUSION

Aripiprazole reduced symptoms of irritability associated with autistic disorder in pediatric subjects ages 6-17 years who were studied for up to 1 year.

Authors+Show Affiliations

Bristol-Myers Squibb, Wallingford, Connecticut, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

21663425

Citation

Marcus, Ronald N., et al. "Aripiprazole in the Treatment of Irritability in Pediatric Patients (aged 6-17 Years) With Autistic Disorder: Results From a 52-week, Open-label Study." Journal of Child and Adolescent Psychopharmacology, vol. 21, no. 3, 2011, pp. 229-36.
Marcus RN, Owen R, Manos G, et al. Aripiprazole in the treatment of irritability in pediatric patients (aged 6-17 years) with autistic disorder: results from a 52-week, open-label study. J Child Adolesc Psychopharmacol. 2011;21(3):229-36.
Marcus, R. N., Owen, R., Manos, G., Mankoski, R., Kamen, L., McQuade, R. D., Carson, W. H., Corey-Lisle, P. K., & Aman, M. G. (2011). Aripiprazole in the treatment of irritability in pediatric patients (aged 6-17 years) with autistic disorder: results from a 52-week, open-label study. Journal of Child and Adolescent Psychopharmacology, 21(3), 229-36. https://doi.org/10.1089/cap.2009.0121
Marcus RN, et al. Aripiprazole in the Treatment of Irritability in Pediatric Patients (aged 6-17 Years) With Autistic Disorder: Results From a 52-week, Open-label Study. J Child Adolesc Psychopharmacol. 2011;21(3):229-36. PubMed PMID: 21663425.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Aripiprazole in the treatment of irritability in pediatric patients (aged 6-17 years) with autistic disorder: results from a 52-week, open-label study. AU - Marcus,Ronald N, AU - Owen,Randall, AU - Manos,George, AU - Mankoski,Raymond, AU - Kamen,Lisa, AU - McQuade,Robert D, AU - Carson,William H, AU - Corey-Lisle,Patricia K, AU - Aman,Michael G, PY - 2011/6/14/entrez PY - 2011/6/15/pubmed PY - 2011/10/8/medline SP - 229 EP - 36 JF - Journal of child and adolescent psychopharmacology JO - J Child Adolesc Psychopharmacol VL - 21 IS - 3 N2 - AIM: To report the long-term efficacy of aripiprazole in the treatment of irritability in children and adolescents (ages 6-17 years) with autistic disorder. METHODS: This was a 52-week, open-label, flexible-dose (2-15 mg/day) study of aripiprazole for the treatment of children and adolescents with irritability associated with autistic disorder. Eligible subjects were enrolled from two 8-week randomized trials or were enrolled as de novo subjects. "Prior aripiprazole" subjects had received treatment with aripiprazole for 8 weeks before entering this study. Evaluation of efficacy, a secondary objective after evaluation of safety and tolerability in this study, was conducted using the caregiver-rated Aberrant Behavior Checklist-Irritability subscale and the clinician-rated Clinical Global Impression-Improvement score. RESULTS: Three hundred thirty subjects received treatment (de novo, n = 86; prior aripiprazole, n = 174; prior placebo, n = 70) and 199 subjects (60.3%) completed 52 weeks of treatment. At their last study visit, 38.2% of subjects were receiving concomitant central nervous system medications (commonly antidepressants, 13.4%; psychostimulants, 11.5%; antiepileptics, 5.9%). At week 52 (observed cases data set), the mean change from baseline in Aberrant Behavior Checklist Irritability subscale scores was -8.0 in de novo subjects and -6.1 in prior placebo subjects; prior aripiprazole subjects maintained symptom improvement that was achieved with treatment in the prior study. At endpoint, the majority of subjects had a Clinical Global Impressions-Improvement score of 2 (much improved) or 1 (very much improved). CONCLUSION: Aripiprazole reduced symptoms of irritability associated with autistic disorder in pediatric subjects ages 6-17 years who were studied for up to 1 year. SN - 1557-8992 UR - https://www.unboundmedicine.com/medline/citation/21663425/Aripiprazole_in_the_treatment_of_irritability_in_pediatric_patients__aged_6_17_years__with_autistic_disorder:_results_from_a_52_week_open_label_study_ L2 - https://www.liebertpub.com/doi/full/10.1089/cap.2009.0121?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -