Aripiprazole in pervasive developmental disorder not otherwise specified and asperger's disorder

A 14-week, prospective, open-label study

Kimberly A. Stigler, Jonathan T. Diener, Arlene E. Kohn, Lang Li, Craig A. Erickson, David J. Posey, Christopher J. McDougle

Research output: Contribution to journalArticle

63 Citations (Scopus)

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 7.8mg=day (range 2.5-15mg=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≤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≤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≤0.04). Prolactin significantly decreased from a mean value of 9.3 at baseline to 2.9 at end point ( p≤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.

Original languageEnglish
Pages (from-to)265-274
Number of pages10
JournalJournal of Child and Adolescent Psychopharmacology
Volume19
Issue number3
DOIs
StatePublished - Jun 1 2009

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Asperger Syndrome
Checklist
Drug-Related Side Effects and Adverse Reactions
Aggression
Intelligence
Prolactin
Aripiprazole
Body Mass Index
Placebos
Outcome Assessment (Health Care)
Pediatrics
Wounds and Injuries
Population

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pediatrics, Perinatology, and Child Health
  • Psychiatry and Mental health

Cite this

Aripiprazole in pervasive developmental disorder not otherwise specified and asperger's disorder : A 14-week, prospective, open-label study. / Stigler, Kimberly A.; Diener, Jonathan T.; Kohn, Arlene E.; Li, Lang; Erickson, Craig A.; Posey, David J.; McDougle, Christopher J.

In: Journal of Child and Adolescent Psychopharmacology, Vol. 19, No. 3, 01.06.2009, p. 265-274.

Research output: Contribution to journalArticle

Stigler, Kimberly A. ; Diener, Jonathan T. ; Kohn, Arlene E. ; Li, Lang ; Erickson, Craig A. ; Posey, David J. ; McDougle, Christopher J. / Aripiprazole in pervasive developmental disorder not otherwise specified and asperger's disorder : A 14-week, prospective, open-label study. In: Journal of Child and Adolescent Psychopharmacology. 2009 ; Vol. 19, No. 3. pp. 265-274.
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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 7.8mg=day (range 2.5-15mg=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≤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≤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≤0.04). Prolactin significantly decreased from a mean value of 9.3 at baseline to 2.9 at end point ( p≤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.",
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AU - Posey, David J.

AU - McDougle, Christopher J.

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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 7.8mg=day (range 2.5-15mg=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≤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≤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≤0.04). Prolactin significantly decreased from a mean value of 9.3 at baseline to 2.9 at end point ( p≤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.

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