Comparison of Atomoxetine and Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) and/or Reading Disorder (RD)

Summary

To test the hypothesis that a 4 week treatment with atomoxetine is more effective than placebo in patients with combined type Attention Deficit/Hyperactivity Disorder (ADHD), patients with only Reading Disorder, and patients with combined type ADHD and Reading Disorder.

Timeline

Start

2005-04

Primary completion

2007-12

Completion

2007-12

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry analysis (superiority or other test); Atomoxetine vs Placebo; p = 0.504; Repeated Measures; note: P-value for Overall. reads as missed primary endpoint NCT00191906 ↗

release “statistically significant improvement for both the patients with ADHD and the patients with ADHD and a comorbid reading disorder” reads as met primary endpoint lilly.com ↗

Publications

• Bangs ME, Wietecha LA, Wang S, Buchanan AS, Kelsey DK. Meta-analysis of suicide-related behavior or ideation in child, adolescent, and adult patients treated with atomoxetine. J Child Adolesc Psychopharmacol. 2014 Oct;24(8):426-34. doi: 10.1089/cap.2014.0005. Epub 2014 Jul 14.
• de Jong CG, Van De Voorde S, Roeyers H, Raymaekers R, Allen AJ, Knijff S, Verhelst H, Temmink AH, Smit LM, Rodriques-Pereira R, Vandenberghe D, van Welsen I, ter Schuren L, Al-Hakim M, Amin A, Vlasveld L, Oosterlaan J, Sergeant JA. Differential effects of atomoxetine on executive functioning and lexical decision in attention-deficit/hyperactivity disorder and reading disorder. J Child Adolesc Psychopharmacol. 2009 Dec;19(6):699-707. doi: 10.1089/cap.2009.0029.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Atomoxetine	Other / unclassified	1.2 mg/kg	Oral

Indications