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Clinical Trial
. 2015 Nov;54(11):905-15.
doi: 10.1016/j.jaac.2015.08.013. Epub 2015 Sep 3.

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

Benjamin L Handen  1 , Michael G Aman  2 , L Eugene Arnold  2 , Susan L Hyman  3 , Rameshwari V Tumuluru  4 , Luc Lecavalier  2 , Patricia Corbett-Dick  3 , Xueliang Pan  5 , Jill A Hollway  2 , Kristin A Buchan-Page  5 , Laura B Silverman  3 , Nicole V Brown  5 , Robert R Rice Jr  5 , Jessica Hellings  2 , Daniel W Mruzek  3 , Sarah McAuliffe-Bellin  4 , Elizabeth A Hurt  2 , Melissa M Ryan  3 , Lynne Levato  3 , Tristram Smith  3
Affiliations
Clinical Trial

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

Benjamin L Handen et al. J Am Acad Child Adolesc Psychiatry. 2015 Nov.

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 years) 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; p values of .0005, .0004, and .025, respectively). For noncompliance, ATX and ATX+PT were superior to placebo (effect sizes 0.47-0.64; p values .03 and .0028, respectively). ATX was associated with decreased appetite but was otherwise well tolerated.

Conclusion: Both ATX and PT resulted in significant improvement on ADHD symptoms, whereas 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.

Clinical trial registration information: Atomoxetine, Placebo and Parent Management Training in Autism; http://clinicaltrials.gov/; NCT00844753.

Keywords: ADHD; atomoxetine; autism spectrum disorder; clinical trial; parent training.

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Conflict of interest statement

Disclosure: Drs. Hyman, Tumuluru, Lecavalier, Pan, Silverman, Rice, Jr., Mruzek, Levato, Smith, and Mss. Corbett-Dick, Buchan-Page, Brown, McAuliffe-Bellin, and Ryan report no biomedical financial interests or potential conflicts of interest.

Figures

Figure 1
Figure 1
Consolidated standards of reporting (CONSORT) diagram. Note: ADHD = attention-deficit/hyperactivity disorder; ASD = autism spectrum disorder; ATX = atomoxetine; PT = parent training.
Figure 2
Figure 2
Parent Swanson, Nolan, and Pelham (SNAP) scales mean attention-deficit/hyperactivity disorder (ADHD) score. Note: ATX = atomoxetine; PT = parent training.
Figure 3
Figure 3
Parent Home Situations Questionnaire (HSQ) mean severity score. Note: ATX = atomoxetine; PT = parent training.
See this image and copyright information in PMC

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