A Randomized, Double-Blind Comparison of Placebo and Atomoxetine Hydrochloride Given Once a Day in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Summary
This is a parallel design, double-blind, placebo-controlled, multi-center, 38-week treatment trial of atomoxetine in adults with attention deficit hyperactivity disorder (ADHD) who are currently living in a family situation with at least one child. The primary objective of the study is to demonstrate the efficacy of atomoxetine compared to placebo in the reduction of ADHD symptoms over 12 and 24 weeks of blinded treatment.
Timeline
- Start
- 2004-09
- Primary completion
- 2009-07
- Completion
- 2009-10
Outcome
Met primary endpoint
registry analysis (superiority or other test); Atomoxetine vs Placebo; p <0.001; Mean Difference (Final Values) -7.78; Mixed Models Analysis NCT00190775 ↗
registry analysis (superiority or other test); Atomoxetine vs Placebo; p = 0.001; Mean Difference (Final Values) -4.28; Mixed Models Analysis NCT00190775 ↗
Publications
- Results Young JL, Sarkis E, Qiao M, Wietecha L. Once-daily treatment with atomoxetine in adults with attention-deficit/hyperactivity disorder: a 24-week, randomized, double-blind, placebo-controlled trial. Clin Neuropharmacol. 2011 Mar-Apr;34(2):51-60. doi: 10.1097/WNF.0b013e31820c00eb.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atomoxetine | Other / unclassified | 60 mg | Oral |
| Subject | Atomoxetine | Other / unclassified | 80 mg | Oral |
| Subject | Atomoxetine | Other / unclassified | 100 mg | Oral |