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Randomized Controlled Trial
. 2017 Feb;27(1):19-28.
doi: 10.1089/cap.2015.0189. Epub 2016 Jul 13.

Effect of Atomoxetine Treatment on Reading and Phonological Skills in Children with Dyslexia or Attention-Deficit/Hyperactivity Disorder and Comorbid Dyslexia in a Randomized, Placebo-Controlled Trial

Sally Shaywitz  1 , Bennett Shaywitz  1 , Linda Wietecha  2 , Sharon Wigal  3 , Keith McBurnett  4 , David Williams  5 , William G Kronenberger  6 , Stephen R Hooper  7
Affiliations
Randomized Controlled Trial

Effect of Atomoxetine Treatment on Reading and Phonological Skills in Children with Dyslexia or Attention-Deficit/Hyperactivity Disorder and Comorbid Dyslexia in a Randomized, Placebo-Controlled Trial

Sally Shaywitz et al. J Child Adolesc Psychopharmacol. 2017 Feb.

Abstract

Objectives: Evaluated the effects of atomoxetine on the reading abilities of children with dyslexia only or attention-deficit/hyperactivity disorder (ADHD) and comorbid dyslexia.

Methods: Children aged 10-16 years (N = 209) met Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for dyslexia only (n = 58), ADHD and comorbid dyslexia (n = 124), or ADHD only (n = 27) and were of normal intelligence. Patients were treated with atomoxetine (1.0-1.4 mg/kg/day) or placebo in a 16-week, randomized, placebo-controlled, double-blind trial. The dyslexia-only and ADHD and comorbid dyslexia groups were randomized 1:1; the ADHD-only group received atomoxetine in a blinded manner. Reading abilities were measured with the Woodcock Johnson III (WJIII), Comprehensive Test of Phonological Processing (CTOPP), Gray Oral Reading Tests-4, and Test of Word Reading Efficiency.

Results: Atomoxetine-treated dyslexia-only patients compared with placebo patients had significantly greater improvement (p < 0.02) with moderate to approaching high effect sizes (ES) on WJIII Word Attack (ES = 0.72), Basic Reading Skills (ES = 0.48), and Reading Vocabulary (ES = 0.73). In the atomoxetine-treated ADHD and comorbid dyslexia group, improvement on the CTOPP Elision measure (ES = 0.50) was significantly greater compared with placebo (p < 0.02). Total, inattentive, and hyperactive/impulsive ADHD symptom reductions were significant in the atomoxetine-treated ADHD and comorbid dyslexia group compared with placebo, and from baseline in the ADHD-only group (p ≤ 0.02). ADHD symptom improvements in the ADHD and comorbid dyslexia group were not correlated with improvements in reading.

Conclusions: Atomoxetine treatment improved reading scores in patients with dyslexia only and ADHD and comorbid dyslexia. Improvements for patients with dyslexia only were in critical components of reading, including decoding and reading vocabulary. For patients with ADHD and comorbid dyslexia, improvements in reading scores were distinct from improvement in ADHD inattention symptoms alone. These data represent the first report of improvements in reading measures following pharmacotherapy treatment in patients with dyslexia only evaluated in a randomized, double-blind trial.

Trial registration: ClinicalTrials.gov NCT00607919.

Keywords: ADHD; atomoxetine; attention; comorbid dyslexia; dyslexia; reading; vocabulary.

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Conflict of interest statement

Sally Shaywitz, Bennett Shaywitz—Research support: Eli Lilly and Company.

Linda Wietecha—An employee and minor shareholder of Eli Lilly and Company and/or one of its subsidiaries.

Sharon Wigal—Research support: Addrenex Pharmaceuticals, Inc.; Eli Lilly and Company; Ironshore Pharmaceutical and Development, Inc.; McNeil Consumer Healthcare; NextWave Pharmaceuticals, Inc.; National Institute of Child Health and Human Development; Noven Pharmaceuticals, Inc.; Otsuka America Pharmaceutical, Inc.; Pfizer, Inc.; PsychoGenics; Quintiles, Inc.; Rhodes Pharmaceuticals, L.P.; Shionogi & Co. Ltd.; Shire; Sunovion Pharmaceuticals, Inc.; and Tris Pharma, Inc. Consultant: Eli Lilly and Company; Ironshore Pharmaceutical and Development, Inc.; McNeil Consumer Healthcare; NextWave Pharmaceuticals, Inc; National Institutes of Health; Noven Pharmaceuticals, Inc.; NuTec Systems, Inc.; Pfizer, Inc.; Shire; Sunovion Pharmaceuticals, Inc; Taisho Pharmaceutical Co., Ltd.; and Tris Pharma, Inc. Speaker's bureau: McNeil Consumer Healthcare; Noven Pharmaceuticals, Inc.; Shionogi & Co. Ltd.; and Shire.

Keith McBurnett—Research support: Abbott; Johnson & Johnson; National Institute of Mental Health; Cephalon, Inc.; New River Pharmaceuticals, Inc.; Otsuka America Pharmaceutical, Inc.; Sigma Tau Pharmaceuticals, Inc.; Eli Lilly and Company; McNeil Pharmaceutical; and Shire. Consultant: Lexicor Medical Technology, Eli Lilly and Company, McNeil Pharmaceuticals, and Shire Pharmaceuticals. Honorarium: Received from Lexicon Pharmaceuticals, Inc.

David W. Williams— A full-time employee of inVentiv Health Clinical, LLC, and was a full-time employee of Eli Lilly and Company until October 2010.

William G. Kronenberger—Research support: Eli Lilly and Company, GlaxoSmithKline Plc, Supernus Pharmaceuticals, Inc., Center for Successful Parenting, National Institutes of Health: National Institute on Deafness and Other Communication Disorders and National Library of Medicine, Indiana University, and Indiana Clinical and Translational Sciences Institute. Consultant: Indiana Hemophilia and Thrombosis Center.

Stephen R. Hooper—Research support: Eli Lilly and Company, U.S. Department of Education Institute of Education Sciences, U.S. Department of Health and Human Services: Maternal and Child Health Bureau, National Institutes of Health: Administration on Developmental Disabilities, National Institute on Deafness and Other Communication Disorders, National Institute on Drug Abuse, National Institute of Diabetes and Digestive and Kidney Diseases, and National Institute of Mental Health. Consultant: Eli Lilly and Company.

Figures

<b>FIG. 1.</b>
FIG. 1.
Flow diagram of subject disposition by treatment and diagnostic category during 16-week, double-blind phase.
<b>FIG. 2.</b>
FIG. 2.
Forest plot of reading measures for dyslexia patients treated with atomoxetine versus placebo. LSMs are raw means after adjustment for study site, gender, and age. Values analyzed by using a type III sums of squares, analysis of variance (ANOVA) model: variable = treatment group+study site+gender+age. CI, confidence interval; LS, least squares.
See this image and copyright information in PMC

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