Journal of the American Academy of Child & Adolescent Psychiatry
New ResearchA Placebo-Controlled, Fixed-Dose Study of Aripiprazole in Children and Adolescents With Irritability Associated With Autistic Disorder
Section snippets
Study Design and Treatment
This multicenter, randomized, double-blind, placebo-controlled trial was conducted at 37 sites in the United States between June 2006 and June 2008 in accordance with the Declaration of Helsinki. Sites were composed of independent research centers and research centers with a hospital affiliation. The institutional review board at each site approved the protocol. All parents/guardians provided written informed consent to participate, and subjects provided written informed assent when possible.
Subject Disposition and Demographics
A total of 368 subjects were enrolled in this study. Of these, 218 were randomized to double-blind treatment (placebo, n = 52; aripiprazole 5 mg/day, n =53; aripiprazole 10 mg/day, n = 59; and aripiprazole 15 mg/day, n = 54); subject disposition is shown in Figure 1. The randomized, double-blind treatment phase was completed by 82% (n = 178) of the subjects and completion rates were similar between treatment arms (Fig. 1). The most common reason for withdrawal in all the treatment groups was
Discussion
In this 8-week study, aripiprazole was effective at reducing irritability in children and adolescents with autistic disorder who also demonstrate irritability, agitation, self-injurious behavior, or a combination of these symptoms. At all doses, aripiprazole produced significantly greater improvements in irritability than the placebo, as measured on the caregiver-rated ABC Irritability subscale. Furthermore, improvements in irritability were rapid, with all treatment arms producing
References (26)
- et al.
Children's Yale-Brown Obsessive Compulsive Scale: reliability and validity
J Am Acad Child Adolesc Psychiatry
(1997) Diagnostic and Statistical Manual of Mental Disorders
(2000)- et al.
Pervasive developmental disorders in preschool children: confirmation of high prevalence
Am J Psychiatry
(2005) - et al.
Pervasive developmental disorders in Montreal, Quebec, Canada: prevalence and links with immunizations
Pediatrics
(2006) - et al.
Summary of the practice parameters for the assessment and treatment of children, adolescents, and adults with autism and other pervasive developmental disorders
JAm Acad Child Adolesc Psychiatry
(1999) Behavioral and emotional problems in young people with pervasive developmental disorders: relative prevalence, effects of subject characteristics, and empirical classification
J Autism Dev Disord
(2006)- et al.
The impact of behaviour problems on caregiver stress in young people with autism spectrum disorders
J Intellect Disabil Res
(2006) - et al.
Management of children with autism spectrum disorders
Pediatrics
(2007) Risperidone in children with autism and serious behavioral problems
N Engl J Med
(2002)- et al.
Risperidone in the treatment of disruptive behavioral symptoms in children with autistic and other pervasive developmental disorders
Pediatrics
(2004)
Tolerability and pharmacokinetics of aripiprazole in children and adolescents with psychiatric disorders: an open-label, dose-escalation study
J Clin Psychopharmacol
A multiple-center, randomized, double-blind, placebo-controlled study of oral aripiprazole for treatment of adolescents with schizophrenia
Am J Psychiatry
An open-label trial of aripiprazole monotherapy in children and adolescents with bipolar disorder
CNS Spectr
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This study was supported by Bristol-Myers Squibb (Princeton, NJ) and Otsuka Pharmaceutical Co., Ltd. (Tokyo, Japan). Editorial support for the preparation of this article was provided by Suzanne Patel and Anna Howarth at Ogilvy Healthworld Medical Education. Bristol-Myers Squibb provided funding for the editorial support. Additional editorial support was provided by Raymond Mankoski of Bristol-Myers Squibb.
The authors thank Dan A. Oren, M.D., and Patricia Corey-Lisle, Ph.D. The authors also thank the patients and their caregivers for their participation in this study.