Atomoxetine improved attention in children and adolescents with
attention-deficit/hyperactivity disorder and dyslexia in a 16 week, acute,
randomized, double-blind trial.
Author(s): Wietecha L(1), Williams D, Shaywitz S, Shaywitz B, Hooper SR, Wigal SB, Dunn D,
McBurnett K.
Affiliation(s): Author information:
(1)1 US Medical Neuroscience, Lilly USA, LLC , Indianapolis, Indiana.
Publication date & source: 2013, J Child Adolesc Psychopharmacol. , 23(9):605-13
OBJECTIVE: The purpose of this study was to evaluate atomoxetine treatment
effects in attention-deficit/hyperactivity disorder (ADHD-only),
attention-deficit/hyperactivity disorder with comorbid dyslexia (ADHD+D), or
dyslexia only on ADHD core symptoms and on sluggish cognitive tempo (SCT),
working memory, life performance, and self-concept.
METHODS: Children and adolescents (10-16 years of age) with ADHD+D (n=124),
dyslexia-only (n=58), or ADHD-only (n=27) received atomoxetine (1.0-1.4
mg/kg/day) or placebo (ADHD-only subjects received atomoxetine) in a 16 week,
acute, randomized, double-blind trial with a 16 week, open-label extension phase
(atomoxetine treatment only). Changes from baseline were assessed to weeks 16 and
32 in ADHD Rating Scale-IV-Parent-Version:Investigator-Administered and Scored
(ADHDRS-IV-Parent:Inv); ADHD Rating Scale-IV-Teacher-Version
(ADHDRS-IV-Teacher-Version); Life Participation Scale-Child- or Parent-Rated
Version (LPS); Kiddie-Sluggish Cognitive Tempo (K-SCT) Interview;
Multidimensional Self Concept Scale (MSCS); and Working Memory Test Battery for
Children (WMTB-C).
RESULTS: At week 16, atomoxetine treatment resulted in significant (p<0.05)
improvement from baseline in subjects with ADHD+D versus placebo on
ADHDRS-IV-Parent:Inv Total (primary outcome) and subscales,
ADHDRS-IV-Teacher-Version Inattentive subscale, K-SCT Interview Parent and
Teacher subscales, and WMTB-C Central Executive component scores; in subjects
with Dyslexia-only, atomoxetine versus placebo significantly improved K-SCT Youth
subscale scores from baseline. At Week 32, atomoxetine-treated ADHD+D subjects
significantly improved from baseline on all measures except MSCS Family subscale
and WMTB-C Central Executive and Visuo-spatial Sketchpad component scores. The
atomoxetine-treated dyslexia-only subjects significantly improved from baseline
to week 32 on ADHDRS-IV-Parent:Inv Inattentive subscale, K-SCT Parent and Teacher
subscales, and WMTB-C Phonological Loop and Central Executive component scores.
The atomoxetine-treated ADHD-only subjects significantly improved from baseline
to Week 32 on ADHDRS-Parent:Inv Total and subscales, ADHDRS-IV-Teacher-Version
Hyperactive/Impulsive subscale, LPS Self-Control and Total, all K-SCT subscales,
and MSCS Academic and Competence subscale scores.
CONCLUSIONS: Atomoxetine treatment improved ADHD symptoms in subjects with ADHD+D
and ADHD-only, but not in subjects with dyslexia-only without ADHD. This is the
first study to report significant effects of any medication on SCT.
CLINICAL TRIALS REGISTRATION: This study was registered at:
http://clinicaltrials.gov/ct2/home, NCT00607919.
|