Aripiprazole in the Treatment of Irritability in Pediatric Patients (Aged 6–17 Years) with Autistic Disorder: Results from a 52-Week, Open-Label Study
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.
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Randomized controlled trials of aripiprazole found a decrease in irritability and hyperactivity and decreased instances of repetitive behaviors in children with ASD over the course of treatment.
“Randomized controlled trials of aripiprazole have also found a decrease in irritability and hyperactivity and decreased instances of repetitive behaviors in children with ASD over the course of treatment [604,605].”
From Reward circuitry dysfunction in psychiatric and neurodevelopmental disorders and genetic syndromes: animal models and clinical findings (2012) · cites this paper as [605]
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- Authors
- Marcus, R. N., Owen, R., Manos, G., Mankoski, R., Kamen, L., McQuade, R. D., Carson, W. H., Corey-Lisle, P. K., & Aman, M. G.
- Affiliations
- Bristol-Myers Squibb (United States) (US)
- Otsuka (United States) (US)
- Bristol-Myers Squibb, Wallingford, Connecticut.
- The Ohio State University (US)
- Corresponding author
- Aman, Michael G.
- ORCID
- Carson, William H.
- Venue
- Journal of Child and Adolescent Psychopharmacology
- Publisher
- SAGE Publications
- Published
- 2011-06
- Volume
- 21
- Issue
- 3
- Pages
- 229-236
- ISSN
- 1044-5463 (ISSN-L)
- 1557-8992
- OpenAlex
- W2019499554
- Cited by
- 82
- References
- 14
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 4 · 2022: 6 · 2021: 9 · 2020: 5 · 2019: 5 · 2018: 5 · 2017: 7 · 2016: 7 · 2015: 6 · 2014: 6 · 2013: 9 · 2012: 10
- FWCI
- 4.06
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Child and Adolescent Psychopharmacology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- U.S. Food and Drug Administration
- Topics
- Life Sciences › Neuroscience › Cognitive Neuroscience › Autism Spectrum Disorder Research
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Keywords
- aripiprazole, irritability, autistic disorder, autism spectrum disorder, pediatric patients, children and adolescents, long-term efficacy, Aberrant Behavior Checklist, Clinical Global Impression Scale, antipsychotic drugs
- MeSH terms
- Aripiprazole, Adolescent, Autistic Disorder, Child, Female, Follow-Up Studies, Humans, Irritable Mood, Male, Piperazines, Psychiatric Status Rating Scales, Antipsychotic Agents, Quinolones, Treatment Outcome
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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