A Randomized, Placebo-Controlled Study of Once-Daily Atomoxetine in the School Setting in Children With ADHD - 21/08/11
ABSTRACT |
Objective |
Five studies have demonstrated the effectiveness of atomoxetine compared with placebo in reducing symptoms of attention-deficit/hyperactivity disorder (ADHD) based on parent reports. The primary objective of this clinical trial was to assess the efficacy of once-daily atomoxetine compared with placebo using teacher reports.
Method |
One hundred fifty-three patients aged 8-12 years were randomly assigned to receive once-daily atomoxetine or placebo in a 2:1 ratio for 7 weeks. ADHD symptoms at school were primarily assessed by baseline-to-endpoint change on the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Teacher Version: Investigator administered and scored (ADHDRS-IV-Teacher:Inv) as rated by investigators using teacher reports.
Results |
ADHDRS-IV-Teacher:Inv total scores were significantly lower for children treated with atomoxetine compared with those treated with placebo (p = .001). Similar results were observed for the inattentive (p = .016) and hyperactive/impulsive (p < .001) ADHDRS-IV-Teacher:Inv subscales, the clinician-rated Clinical Global Impressions severity scale (p = .001), the Conners Global Index-Teacher scale (p = .008), and the Conners Parent Rating Scale-Revised: Short Form ADHD Index T-Score (p < .001). Discontinuations due to adverse events were low in both groups (atomoxetine 5.9%, placebo 0%, p = .096).
Conclusions |
This study extends previous results based on parent reports showing that once-daily administration of atomoxetine is safe and effective in improving ADHD symptoms in children and demonstrates that outcomes at school are similar when symptoms are reported by teachers.
Le texte complet de cet article est disponible en PDF.Key Words : attention-deficit/hyperactivity disorder, school, atomoxetine, nonstimulants
Plan
| Research funded by Eli Lilly and Company. The authors acknowledge Charles Bailey, M.D., Charles Casat, M.D., Joan Busner, M.D., Rakesh Jain, M.D., Anthony Dietrich, M.D., Richard Rubin, M.D., and Lesley Reese for their contributions. Article Plus (online only) materials for this article appear on the Journal’s Web site: www.jaacap.com. Disclosure: Drs. Tannock, Weiss, Kratochvil, Dunn, and Velez-Borras were paid consultants and/or investigators for studies sponsored by Eli Lilly and Company. Drs. Allen, Tamura, and Kelsey and Ms. Stevens are employees and shareholders of Eli Lilly and Company. Dr. Thomason is a former employee and stakeholder of Eli Lilly and Company. Dr. Weiss is a consultant, clinical investigator, and speaker for Janssen, Shire, Eli Lilly, Purdue, Novartis, and Circa Dia. Dr. Tannock is a recipient of grants for research support from Eli Lilly and Novartis and a consultant for Eli Lilly and Shire as well as a speaker for Eli Lilly. Dr. Kratochvil is a recipient of grants for research support from Eli Lilly, GlaxoSmithKline, Cephalon, and McNeil, a consultant for Eli Lilly, and a speaker for Eli Lilly and Novartis. Dr. Dunn is a recipient of grants for research support from AstraZeneca, Eli Lilly, and Shire and a speaker for Eli Lilly, McNeil, and UCB Pharma. Dr. Velez-Borras is a recipient of grants for research support from Eli Lilly and GlaxoSmithKline and a member of the speaker’s bureau of Eli Lilly and Novartis. |
Vol 44 - N° 7
P. 647-655 - juillet 2005 Retour au numéro
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