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Aripiprazole in pervasive developmental disorder not otherwise specified and Asperger's disorder: a 14-week, prospective, open-label study.
J Child Adolesc Psychopharmacol. 2009 Jun; 19(3):265-74.JC

Abstract

OBJECTIVE

The aim of this study was to determine the effectiveness and tolerability of aripiprazole for irritability in pervasive developmental disorder not otherwise specified (PDD-NOS) and Asperger's disorder.

METHOD

This is a 14-week, prospective, open-label investigation of aripiprazole in 25 children and adolescents diagnosed with PDD-NOS or Asperger's disorder. Primary outcome measures included the Clinical Global Impressions-Improvement (CGI-I) scale and the Irritability subscale of the Aberrant Behavior Checklist (ABC-I).

RESULTS

Twenty-five subjects, ages 5-17 years (mean 8.6 years) received a mean final aripiprazole dosage of 7.8 mg/day (range 2.5-15 mg/day). Full-scale intelligence quotient (IQ) scores ranged from 48 to 122 (mean 84). Twenty-two (88%) of 25 subjects were responders in regard to interfering symptoms of irritability, including aggression, self-injury, and tantrums, with a final CGI-I of 1 or 2 (very much or much improved) and a 25% or greater improvement on the ABC-I. The final mean CGI-I was 1.6 (p <or= 0.0001). ABC-I scores ranged from 18 to 43 (mean 29) at baseline, whereas scores at week 14 ranged from 0 to 27 (mean 8.1) (p <or= 0.001). Aripiprazole was well tolerated. Mild extrapyramidal symptoms (EPS) were reported in 9 subjects. Age- and sex-normed body mass index (BMI) increased from a mean value of 20.3 at baseline to 21.1 at end point (p <or= 0.04). Prolactin significantly decreased from a mean value of 9.3 at baseline to 2.9 at end point (p <or= 0.0001). No subject exited the study due to a drug-related adverse event.

CONCLUSIONS

These preliminary data suggest that aripiprazole may be effective and well tolerated for severe irritability in pediatric patients with PDD-NOS or Asperger's disorder. Larger-scale placebo-controlled studies are needed to elucidate the efficacy and tolerability of aripiprazole in this understudied population.

Authors+Show Affiliations

Department of Psychiatry, Section of Child & Adolescent Psychiatry, Indiana University School of Medicine and Christian Sarkine Autism Treatment Center, James Whitcomb Riley Hospital for Children, Indianapolis, Indiana 46202-5200, USA. kstigler@iupui.eduNo 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
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19519261

Citation

Stigler, Kimberly A., et al. "Aripiprazole in Pervasive Developmental Disorder Not Otherwise Specified and Asperger's Disorder: a 14-week, Prospective, Open-label Study." Journal of Child and Adolescent Psychopharmacology, vol. 19, no. 3, 2009, pp. 265-74.
Stigler KA, Diener JT, Kohn AE, et al. Aripiprazole in pervasive developmental disorder not otherwise specified and Asperger's disorder: a 14-week, prospective, open-label study. J Child Adolesc Psychopharmacol. 2009;19(3):265-74.
Stigler, K. A., Diener, J. T., Kohn, A. E., Li, L., Erickson, C. A., Posey, D. J., & McDougle, C. J. (2009). Aripiprazole in pervasive developmental disorder not otherwise specified and Asperger's disorder: a 14-week, prospective, open-label study. Journal of Child and Adolescent Psychopharmacology, 19(3), 265-74. https://doi.org/10.1089/cap.2008.093
Stigler KA, et al. Aripiprazole in Pervasive Developmental Disorder Not Otherwise Specified and Asperger's Disorder: a 14-week, Prospective, Open-label Study. J Child Adolesc Psychopharmacol. 2009;19(3):265-74. PubMed PMID: 19519261.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Aripiprazole in pervasive developmental disorder not otherwise specified and Asperger's disorder: a 14-week, prospective, open-label study. AU - Stigler,Kimberly A, AU - Diener,Jonathan T, AU - Kohn,Arlene E, AU - Li,Lang, AU - Erickson,Craig A, AU - Posey,David J, AU - McDougle,Christopher J, PY - 2009/6/13/entrez PY - 2009/6/13/pubmed PY - 2009/8/19/medline SP - 265 EP - 74 JF - Journal of child and adolescent psychopharmacology JO - J Child Adolesc Psychopharmacol VL - 19 IS - 3 N2 - OBJECTIVE: The aim of this study was to determine the effectiveness and tolerability of aripiprazole for irritability in pervasive developmental disorder not otherwise specified (PDD-NOS) and Asperger's disorder. METHOD: This is a 14-week, prospective, open-label investigation of aripiprazole in 25 children and adolescents diagnosed with PDD-NOS or Asperger's disorder. Primary outcome measures included the Clinical Global Impressions-Improvement (CGI-I) scale and the Irritability subscale of the Aberrant Behavior Checklist (ABC-I). RESULTS: Twenty-five subjects, ages 5-17 years (mean 8.6 years) received a mean final aripiprazole dosage of 7.8 mg/day (range 2.5-15 mg/day). Full-scale intelligence quotient (IQ) scores ranged from 48 to 122 (mean 84). Twenty-two (88%) of 25 subjects were responders in regard to interfering symptoms of irritability, including aggression, self-injury, and tantrums, with a final CGI-I of 1 or 2 (very much or much improved) and a 25% or greater improvement on the ABC-I. The final mean CGI-I was 1.6 (p <or= 0.0001). ABC-I scores ranged from 18 to 43 (mean 29) at baseline, whereas scores at week 14 ranged from 0 to 27 (mean 8.1) (p <or= 0.001). Aripiprazole was well tolerated. Mild extrapyramidal symptoms (EPS) were reported in 9 subjects. Age- and sex-normed body mass index (BMI) increased from a mean value of 20.3 at baseline to 21.1 at end point (p <or= 0.04). Prolactin significantly decreased from a mean value of 9.3 at baseline to 2.9 at end point (p <or= 0.0001). No subject exited the study due to a drug-related adverse event. CONCLUSIONS: These preliminary data suggest that aripiprazole may be effective and well tolerated for severe irritability in pediatric patients with PDD-NOS or Asperger's disorder. Larger-scale placebo-controlled studies are needed to elucidate the efficacy and tolerability of aripiprazole in this understudied population. SN - 1557-8992 UR - https://www.unboundmedicine.com/medline/citation/19519261/Aripiprazole_in_pervasive_developmental_disorder_not_otherwise_specified_and_Asperger's_disorder:_a_14_week_prospective_open_label_study_ L2 - https://www.liebertpub.com/doi/full/10.1089/cap.2008.093?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -