Aripiprazole for Irritability Associated with Autistic Disorder in Children and Adolescents Aged 6–17 Years

Kelly Blankenship; Craig A Erickson; Kimberly A Stigler; David J Posey; Christopher J McDougle


Pediatr Health. 2010;4(4):375-381. 

In This Article

Abstract and Introduction


Aripiprazole was recently US FDA-approved to treat irritability in children and adolescents with autistic disorder aged 6–17 years. There are currently only two psychotropics approved by the FDA to treat irritability in the autistic population. This drug profile will discuss available studies of aripiprazole in individuals with pervasive developmental disorders, two of which led to its recent FDA approval. We will discuss the efficacy, as well as the safety and tolerability of the drug documented in these studies. In addition, the chemistry, pharmacokinetics, metabolism and mechanism of action of aripiprazole will be reviewed.


Autistic disorder (autism) is a neuropsychiatric syndrome characterized by deficits in social interaction, qualitative impairments in communication and restricted repetitive and stereotyped patterns of behavior, interests or activities. It is classified as a type of pervasive developmental disorder (PDD). PDD not otherwise specified, Asperger's disorder, Rett's disorder and childhood disintegrative disorder represent the other diagnostic types of PDDs.[1] All types of PDDs have a qualitative impairment in social relatedness. However, many individuals with PDDs also have other interfering symptoms, including irritability (aggression, self-injurious behavior and severe tantrums). Behavioral therapy is often helpful in decreasing these behaviors; however, sometimes medications are needed adjunctively owing to the intensity and severity of the irritability.[2]

The typical antipsychotics were one of the initial classes of medication to be studied for the treatment of irritability in autism.[2,3] However, concerns regarding their propensity to cause extrapyramidal symptoms (EPS) limited their use.[2,4–7] Atypical antipsychotics have largely replaced the use of typical antipsychotics to treat irritability in autism.[3] Atypical antipsychotics are thought to result in less tardive dyskinesia (TD) and EPS compared with typical antipsychotics owing to differences in D2-receptor affinity.

Until recently, risperidone was the most studied and the only psychotropic approved by the US FDA to treat irritability related to autism. Aripiprazole has recently undergone several placebo-controlled studies validating its use in individuals with irritability associated with autistic disorder, leading to its recent US FDA approval.


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