ERIC Number: EJ698912
Record Type: Journal
Publication Date: 2005-Jul
Reference Count: N/A
A Randomized, Placebo-Controlled Study of Once-Daily Atomoxetine in the School Setting in Children with ADHD
Weiss, Margaret; Tannock, Rosemary; Kratochvil, Christopher; Dunn, David; Velez-Borras, Jesus; Thomason, Christine; Tamura, Roy; Kelsey, Douglas; Stevens, Linda; Allen, Albert J.
Journal of the American Academy of Child and Adolescent Psychiatry, v44 n7 p647-655 Jul 2005
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 is less than .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 is less than .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.
Descriptors: Measures (Individuals), Symptoms (Individual Disorders), Student Behavior, Hyperactivity, Attention Deficit Disorders, Drug Therapy, Children, Attention Span, Teacher Attitudes, Behavior Change
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Publication Type: Journal Articles; Reports - Research
Education Level: N/A
Authoring Institution: N/A