NCT00938743

Driving in Adults With Attention-deficit/Hyperactivity Disorder (ADHD) Before and During Treatment With Atomoxetine

Driving Ability in Adults With ADHD Before and After 10-weeks of Treatment With 40-80mg Atomoxetine vs. Untreated Adults With ADHD

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Central Institute of Mental Health, Mannheim · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

According available data individuals with ADHD are impaired in their driving ability which can be improved by stimulant medication. The impact of the specific noradrenalin-reuptake-inhibitor atomoxetine on driving ability of patients with ADHD has never been studied so far. The present study aims to evaluate the effects of atomoxetine treatment in patients with ADHD on practical driving abilities which will be assessed with a standardized driving test, a structured one-week driving diary and driving related neuropsychological processing especially different aspects of attention and executive functions which will be assessed with a neuropsychological test battery designed for the assessment of drivers fitness. A functional magnetic resonance imaging (fMRI) - investigation will also be performed at the beginning and after a 10-week treatment with atomoxetine. The study will be conducted in a single-blind placebo controlled parallel group design in cooperation of the academic Adult ADHD-outpatient clinics of the Central Institute of Mental Health, Mannheim and the Institute of Legal and Traffic Medicine of the University of Heidelberg, Germany. It is expected that treatment with atomoxetine will improve practical driving abilities and driving related neuropsychological processing. It is expected that risk taking and impulsive decision making will be reduced and sustained attention and overview of complex traffic situations will be improved while driving.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Atomoxetine	40-80 mg atomoxetine once daily, including titration 10 weeks

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2009-07-14
• Last updated: 2011-01-20

Locations

1 site across 1 country: Germany