Atomoxetine, Parent Training, and Their Combination in Children With Autism Spectrum Disorder and Attention-Deficit/Hyperactivity Disorder

Abstract

Objective Impairments associated with attention-deficit/hyperactivity disorder (ADHD) and noncompliance are prevalent in children with autism spectrum disorder (ASD). However, ADHD response to stimulants is well below rates in typically developing children, with frequent side effects. Group studies of treatments for noncompliance are rare in ASD. We examined individual and combined-effectiveness of atomoxetine (ATX) and parent training (PT) for ADHD symptoms and noncompliance. Method In a 3-site, 10-week, double-blind, 2×2 trial of ATX and PT, 128 children (ages 5–14) with ASD and ADHD symptoms were randomized to ATX, ATX+PT, placebo+PT, or placebo. ATX was adjusted to optimal dose (capped at 1.8 mg/kg/day) over 6 weeks and maintained for 4 additional weeks. Nine PT sessions were provided. Primary outcome measures were the parent-rated DSM ADHD symptoms on the Swanson, Nolan and Pelham (SNAP) scale and Home Situations Questionnaire (HSQ). Results On the SNAP, ATX, ATX+PT and placebo+PT were each superior to placebo (effect sizes 0.57–0.98), with p-values of 0.0005, 0.0004 and 0.025, respectively. For noncompliance, ATX and ATX+PT were superior to placebo (effect sizes 0.47–0.64; p values of .03 and .0028, respectively). ATX was associated with decreased appetite but otherwise well-tolerated. Conclusion Both ATX and PT resulted in significant improvement on ADHD symptoms while ATX (both alone and combined with PT) was associated with significant decreases on measures of noncompliance. ATX appears to have a better side effects profile than psychostimulants in the population with ASD.

Testing Genetic Modifiers of Behavior and Response to Atomoxetine in Autism Spectrum Disorder with ADHD

“…CHARTS was a 10-week randomized double-blind, placebo-controlled, parallel groups study of atomoxetine (Strattera) and parent training for children with ASD and ADHD (Handen et al, 2015). The sample comprised participants from three sites (total with genetic material, N=59, female n=11).…”

“…A subset of participants were treated with the norepinephrine reuptake inhibitor atomoxetine, which reduces ADHD symptoms in 26–46% of children who have ASD with co-occurring ADHD (Handen et al, 2015; Harfterkamp et al, 2012). Atomoxetine is metabolized by CYP2D6, so we used a CYP2D6 genotyping panel to test for an effect on ADHD-symptom reduction by classifying subject metabolizer status.…”

Assessment the Efficacy of Atomoxetine in Autism Spectrum Disorders: A Randomized, Double-Blind, Placebo-Controlled Trial

“…Also, Handen et al, (8) evaluated 128 children with ASD and ADHD symptoms who were divided into 4 groups as Atomoxetine, Atomoxetine + Parent training, Placebo + Parent training, and Placebo. Instrument research were parent DSM-ADHD symptoms and home situation questionnaire (HSQ).…”

“…Also, the side effect profile is well tolerated versus other treatments (8). The safety and effectiveness of Atomoxetine was proved in patients with ASD for social withdrawal and ADHD symptoms (9).…”

Autism spectrum disorder clinical trials: One step at a time

“…Involved treatment studies are not the untenured scholar's friend. For instance, both our recent parent training trial (Bearss et al, 2015) and atomoxetine and parent training study (Handen et al, 2015) took about 6 years to execute. This number approaches 10 years when including grant and manuscript writing.…”