Aripiprazole in the treatment of irritability in children and adolescents with autistic disorder.
نویسندگان
چکیده
OBJECTIVE The objective of this study was to evaluate short-term efficacy and safety of aripiprazole in the treatment of irritability in children and adolescents with autistic disorder who were manifesting behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these. METHODS This 8-week, double-blind, randomized, placebo-controlled, parallel-group study was conducted of children and adolescents (aged 6-17 years) with autistic disorder. Patients were randomly assigned (1:1) to flexibly dosed aripiprazole (target dosage: 5, 10, or 15 mg/day) or placebo. Efficacy outcome measures included the Aberrant Behavior Checklist irritability subscale and the Clinical Global Impression-Improvement score (CGI-I). Safety and tolerability were also assessed. RESULTS Ninety-eight patients were randomly assigned to receive placebo (n = 51) or aripiprazole (n = 47). Mean improvement in Aberrant Behavior Checklist irritability subscale score was significantly greater with aripiprazole than with placebo from week 1 through week 8. Aripiprazole demonstrated significantly greater global improvements than placebo, as assessed by the mean CGI-I score from week 1 through week 8; however, clinically significant residual symptoms may still persist for some patients. Discontinuation rates as a result of adverse events (AEs) were 10.6% for aripiprazole and 5.9% for placebo. Extrapyramidal symptom-related AE rates were 14.9% for aripiprazole and 8.0% for placebo. No serious AEs were reported. Mean weight gain was 2.0 kg on aripiprazole and 0.8 kg on placebo at week 8. CONCLUSIONS Aripiprazole was efficacious in children and adolescents with irritability associated with autistic disorder and was generally safe and well tolerated.
منابع مشابه
Efficacy and Safety of Aripiprazole for Treatment of Irritability in Children with Autistic Disorder: An Open-Label Study
متن کامل
Aripiprazole: A Review of its Use in the Treatment of Irritability Associated with Autistic Disorder Patients Aged 6–17
A systematic review and meta-analysis were performed examining the efficacy of aripiprazole for the treatment of irritability associated with autistic disorder in children and adolescents. Aripiprazole was found to be more effective in reducing irritability compared with placebo at 8 weeks, SMD -0.64 [-0.90 to -0.39, P < 0.00001] as determined by the Aberrant Behaviour Checklist irritability su...
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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). Aripipr...
متن کاملEmerging role of aripiprazole for treatment of irritability associated with autistic disorder in children and adolescents
Autistic disorder is a largely misunderstood and difficult to treat neurodevelopmental disorder. Three core domains of functioning are affected by autistic disorder, ie, socialization, communication, and behavior. Signs of autistic disorder may be present early, but are frequently overlooked, resulting in a delay in its diagnosis and a subsequent delay in treatment. No one definitive therapy is...
متن کاملAripiprazole for treating irritability in children & adolescents with autism: a systematic review
BACKGROUND & OBJECTIVES No clear therapeutic benefits of antipsychotics have been reported for the treatment of behavioural symptoms in autism. This systematic review provides an assessment of evidence for treating irritability in autism by aripiprazole. METHODS The databases of MEDLINE/PubMed and Google Scholar were searched for relevant articles about the effect of aripiprazole in children ...
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ورودعنوان ژورنال:
- Pediatrics
دوره 124 6 شماره
صفحات -
تاریخ انتشار 2009