Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2017 Oct;48(5):796-806.
doi: 10.1007/s10578-016-0704-x.

Aripiprazole in the Treatment of Irritability in Children and Adolescents with Autism Spectrum Disorder in Japan: A Randomized, Double-blind, Placebo-controlled Study

Hironobu Ichikawa  1 , Katsunaka Mikami  2 , Takashi Okada  3 , Yushiro Yamashita  4 , Yuko Ishizaki  5 , Akemi Tomoda  6 , Hiroaki Ono  7 , Chiharu Usuki  7 , Yoshihiro Tadori  8
Affiliations
Randomized Controlled Trial

Aripiprazole in the Treatment of Irritability in Children and Adolescents with Autism Spectrum Disorder in Japan: A Randomized, Double-blind, Placebo-controlled Study

Hironobu Ichikawa et al. Child Psychiatry Hum Dev. 2017 Oct.

Abstract

We evaluated the efficacy and safety of aripiprazole in the treatment of irritability in children and adolescents (6-17 years) with autism spectrum disorder (ASD) in a randomized, double-blind, placebo-controlled 8-week study in Japan. Patients received flexibly dosed aripiprazole (1-15 mg/day) or placebo. Ninety-two patients were randomized to placebo (n = 45) or aripiprazole (n = 47). Aripiprazole produced a significant improvement in the mean parent/caregiver-rated Aberrant Behavior Checklist Japanese Version irritability subscale score relative to placebo from week 3 through week 8. Administration of aripiprazole provided significantly greater improvement in the mean clinician-rated Clinical Global Impression-Improvement scores than placebo from week 2 through week 8. All patients randomized to aripiprazole completed the study, and no serious adverse events were reported. Three patients in placebo group discontinued. Aripiprazole was effective and generally safe and well-tolerated in the treatment of irritability associated with ASD in Japanese children and adolescents.

Keywords: Aripiprazole; Autism spectrum disorder; Children and adolescent; Irritability.

PubMed Disclaimer

Conflict of interest statement

Mr. Ono, Ms. Usuki and Dr. Tadori are employees of Otsuka Pharmaceutical Co., Ltd.

Figures

Fig. 1
Fig. 1
Subject disposition
Fig. 2
Fig. 2
Patient distribution of the last doses of aripiprazole and placebo corresponding to aripiprazole
Fig. 3
Fig. 3
Mean change from baseline in ABC-J Irritability score by week (LOCF; efficacy sample). Data are expressed as least squares mean (standard error). ABC-J Aberrant Behavior Checklist Japanese Version, LOCF last observation carried forward. *P < 0.05; **P < 0.01 versus placebo
Fig. 4
Fig. 4
Mean CGI-I score by week (LOCF; efficacy sample). Data are expressed as least squares mean (standard error). CGI-I clinical global impressions-improvement score, LOCF last observation carried forward. **P < 0.01; ***P < 0.001 versus placebo
Fig. 5
Fig. 5
Treatment response rate by week (LOCF; efficacy sample). The treatment response was defined as ≥25% reduction from baseline in the Aberrant Behavior Checklist Japanese Version Irritability subscale score and a Clinical Global Impressions-Improvement score of 1 or 2. LOCF last observation carried forward. *P < 0.05; **P < 0.01 versus placebo
See this image and copyright information in PMC

References

    1. American Psychiatric Association . Diagnostic and statistical manual of mental disorders. 4. Washington: American Psychiatric Association; 2000.
    1. American Psychiatric Association . Diagnostic and statistical manual of mental disorders. 5. Arlington: American Psychiatric Publishing; 2013.
    1. Volkmar F, Cook EH, Jr, Pomeroy J, Realmuto G, Tanguay P. Practice parameters for the assessment and treatment of children, adolescents, and adults with autism and other pervasive developmental disorders. American Academy of Child and Adolescent Psychiatry Working Group on Quality Issues. J Am Acad Child Adolesc Psychiatry. 1999;38(12 suppl):32S–54S. doi: 10.1016/S0890-8567(99)80003-3. - DOI - PubMed
    1. Myers SM, Johnson CP, American Academy of Pediatrics Council on Children With Disabilities Management of children with autism spectrum disorders. Pediatrics. 2007;120:1162–1182. doi: 10.1542/peds.2007-2362. - DOI - PubMed
    1. Tadori Y, Kitagawa H, Forbes R, McQuade RD, Stark A, Kikuchi T. Differences in agonist/antagonist properties at human dopamine D2 receptors between aripiprazole, bifeprunox and SDZ 208–912. Eur J Pharmacol. 2007;574:103–111. doi: 10.1016/j.ejphar.2007.07.031. - DOI - PubMed

Publication types