Bibliographic Details
| Title: |
Aripiprazole in the Treatment of Irritability in Children and Adolescents with Autism Spectrum Disorder in Japan: A Randomized, Double-blind, Placebo-controlled Study. |
| Authors: |
Ichikawa, Hironobu1, Mikami, Katsunaka2, Okada, Takashi3, Yamashita, Yushiro4, Ishizaki, Yuko5, Tomoda, Akemi6, Ono, Hiroaki7, Usuki, Chiharu7, Tadori, Yoshihiro8 Tadori.Yoshihiro@otsuka.jp |
| Source: |
Child Psychiatry & Human Development. Oct2017, Vol. 48 Issue 5, p796-806. 11p. |
| Subject Terms: |
*ARIPIPRAZOLE, *IRRITABILITY (Psychology), *AUTISM spectrum disorders in children, *AUTISM spectrum disorders, *FRUSTRATION in children, *ANGER in adolescence, *ANGER in children, *AFFECT (Psychology), *ANTIPSYCHOTIC agents, *COMPARATIVE studies, *RESEARCH methodology, *MEDICAL cooperation, *PARENTS, *PLACEBOS, *RESEARCH, *STATISTICAL sampling, *EVALUATION research, *RANDOMIZED controlled trials, *TREATMENT effectiveness, *BLIND experiment, *PHARMACODYNAMICS |
| Geographic Terms: |
JAPAN |
| 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. [ABSTRACT FROM AUTHOR] |
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| Database: |
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