Journal of the American Academy of Child & Adolescent Psychiatry
ARTICLESAtomoxetine for Hyperactivity in Autism Spectrum Disorders: Placebo-Controlled Crossover Pilot Trial
Section snippets
Subjects
Participants were children/adolescents ages 5 to 15 years with mental age ≥18 months who had an ASD and symptoms of ADHD. They met the first four of five DSM-IV criteria for ADHD: symptom count, impairment, chronicity, and pervasiveness across settings (the fifth criterion would technically rule out ADHD by the presence of PDD) and had to have a parent-rated symptom mean ≥1.5 on either the nine inattentive or the nine hyperactive-impulsive ADHD symptoms, rated 0 to 3. Exclusion criteria
RESULTS
Sixteen subjects (Table 1) were randomized. Three terminated early, one each after the third, fourth, and fifth weeks of the second condition (one on ATX, twoon placebo). The intent-to-treat analysis included all 16. The mean highest dose was 44.2 ± 21.9 mg/day (range 20-100mg) for ATX and 48.0 mg/day (range 20-100) for placebo; dose did not correlate significantly with either initial severity (p =.6) or degree of improvement (p =.7).
Table 2 shows the outcome means (SD) at baseline and week 6
DISCUSSION
The placebo-controlled effect sizes (d = 0.89-1.27) reported here for ADHD symptoms in the presence of ASD are as good as those reported (Michelson et al., 2002, Michelson et al., 2004, Sutton et al., 2004) for typically developing children (d= 0.6-1.0), and at least as good as those for MPH (d = 0.5-0.89 rated by parents, 0.35-0.48 rated by teachers) found in the multisite RUPP Autism Network (2005) study in the same population. Nevertheless, the response rate (57% and 43%, after subtracting
REFERENCES (41)
- et al.
A post hoc subgroup analysis of an 18-day randomized controlled trial comparing the tolerability and efficacy of mixed amphetamine salts extended release and atomoxetine in school-age girls with ADHD
Clin Ther
(2006) - et al.
Relapse prevention in pediatric patients with ADHD treated with atomoxetine: a randomized, double-blind, placebo-controlled study
J Am Acad Child Adolesc Psychiatry
(2004) - et al.
Atomoxetine treatment in children and adolescents with attention-deficit/hyperactivity disorder and comorbid oppositional-defiant disorder
J Am Acad Child Adolesc Psychiatry
(2005) - et al.
Treatment effects of methylphenidate on cognitive functioning in children with mental retardation and ADHD
J Am Acad Child Adolesc Psychiatry
(2004) Applications of computerized cognitive-motor measures to the assessment of psychoactive drugs.
Stimulant drugs in the developmental disabilities revisited
J Dev Phys Disord
(1996)- et al.
Methylphenidate treatment in children with borderline IQ and mental retardation: analysis of three aggregated studies
J Child Adolesc Psychopharmacol
(2003) - et al.
Medication patterns in patients with autism: temporal, regional, and demographic influences
J Child Adolesc Psychopharmacol
(2005) - et al.
The Aberrant Behavior Checklist: a behavior rating scale for the assessment of treatment effects
Am J Ment Defic
(1985) - et al.
Psychometric characteristics of the Aberrant Behavior Checklist
Am J Ment Defic
(1985)
Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV)
Stimulants.
Efficacy of atomoxetine versus placebo in school-age girls with attention-deficit/hyperactivity disorder
Pediatrics
Methylphenidate treatment of hyperactive autistic children
J Am Acad Child Adolesc Psychiatry
The Repetitive Behavior Scale
Varieties of repetitive behavior in autism
J Autism Dev Disord
A prospective, multicenter, open-label assessment of atomoxetine in non-North American children and adolescents with ADHD
Eur Child Adolesc Psychiatry
Response to tri-iodothyronine and dextroamphetamine: a study of preschool schizophrenic children
J Autism Child Schizophr
Levodopa and levoamphetamine: a crossover study in young schizophrenic children
Curr Ther Res
Glutamatergic changes with treatment in attention deficit hyperactivity disorder: a preliminary case series
J Child Adolesc Psychopharmacol
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Disclosure: The authors receive research funding from Lilly, Shire, Janssen, and PediaMed and are on speakers' bureaus of and/or consult for Shire, Novartis, Janssen, Sigma Tau, and Forest Laboratories.
This investigator-initiated study was supported by Eli Lilly and by the General Clinical Research Center at the Ohio State University, GrantM01-RR00034 from the National Center of Research Resources, NIH.