Atomoxetine, Parent Training, and Their Combination in Children With Autism Spectrum Disorder and Attention-Deficit/Hyperactivity Disorder - 23/10/15
, Michael G. Aman, PhD b, L. Eugene Arnold, MD b, Susan L. Hyman, MD c, Rameshwari V. Tumuluru, MD a, Luc Lecavalier, PhD b, Patricia Corbett-Dick, PNP c, Xueliang Pan, PhD d, Jill A. Hollway, PhD b, Kristin A. Buchan-Page, BS d, Laura B. Silverman, PhD c, Nicole V. Brown, MS d, Robert R. Rice, PhD d, Jessica Hellings, MD b, Daniel W. Mruzek, PhD c, Sarah McAuliffe-Bellin, MEd a, Elizabeth A. Hurt, PhD b, Melissa M. Ryan, CPNP c, Lynne Levato, PhD c, Tristram Smith, PhD cAbstract |
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; clinicaltrials.gov/; NCT00844753.
Le texte complet de cet article est disponible en PDF.Key Words : atomoxetine, parent training, ADHD, autism spectrum disorder, clinical trial
Plan
| This work was supported by grants from the National Institute of Mental Health to Ohio State University (5R01MH079080), University of Pittsburgh (5R01MH079082-05), and University of Rochester (5R01 MH083247), by Eli Lilly and Co., who provided atomoxetine and placebo, and by the University of Rochester CTSA (UL1 RR024160) and Ohio State University CTSA (UL1TR001070) from the National Center for Research Resources and the National Center for Advancing Translational Sciences of the National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health (NIH). |
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| Dr. Pan served as the statistical expert for this research. |
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| The authors gratefully acknowledge the guidance and supervision of the DSMB, consisting of Edwin H. Cook, Jr., MD (University of Illinois at Chicago), Walter J. Meyer, MD (University of Texas-Galveston), Carson R. Reider, PhD (Ohio State University), and Wesley K. Thompson, PhD (University of California-San Diego). |
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| Disclosure: Dr. Handen has received research funding from Curemark, Eli Lilly and Co., and Roche. Dr. Aman has received research contracts, consulted with, served on advisory boards, or done investigator training for Biomarin Pharmaceuticals, Bristol-Myers Squibb, CogState, Inc., Confluence Pharmaceutica, CogState Clinical Trials, Ltd., Coronado Biosciences, Forest Research, Hoffman-La Roche, Johnson and Johnson, MedAvante, Inc., Novartis, Pfizer, ProPhase LLC, and Supernus Pharmaceuticals. Dr. Arnold has received research funding from Curemark, Forest, Eli Lilly and Co., Neuropharm, Novartis, Noven, Shire, Young Living, NIH, and Autism Speaks, and has consulted with or been on advisory boards for Gowlings, Neuropharm, Novartis, Noven, Organon, Otsuka, Pfizer, Roche, Seaside Therapeutics, Sigma Tau, Shire, and Tris Pharma, and has received travel support from Noven. Dr. Hollway has received research funding from Forest, Sunovion, and Supernus. Dr. Hellings has received research funding from Sunovion, has been an investigator for Forest and Shire, and has authorship collaboration with Roche. Dr. Hurt has received research funding from Bristol-Myers Squibb. 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. |
Vol 54 - N° 11
P. 905-915 - novembre 2015 Retour au numéro
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