Driving in Adults With Attention-deficit/Hyperactivity Disorder (ADHD) Before and During Treatment With Atomoxetine (DrivPerfATX)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Driving Ability in Adults With ADHD Before and After 10-weeks of Treatment With 40-80mg Atomoxetine vs. Untreated Adults With ADHD|
- Standardized practical driving test [ Time Frame: 1/2010 ] [ Designated as safety issue: No ]
- Action-Reaction-Test Battery [ Time Frame: 1/2010 ] [ Designated as safety issue: Yes ]
- Performance criteria for drivers' fitness according to the "Guidelines of Driver Fitness" [ Time Frame: 1/2010 ] [ Designated as safety issue: Yes ]
- Safety measures including vital signs, laboratory test, ECG, assessment of SAEs [ Time Frame: 1/2010 ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2008|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Active Comparator: Atomoxetine
Treatment with a final dosis of 40-80mg atomoxetine daily
40-80 mg atomoxetine once daily, including titration 10 weeks
|No Intervention: Waiting list|