Methylphenidate and Driving Ability in Adult Patients With Attention-Deficit Hyperactivity Disorder
Phase 4
Completed
- Conditions
- ADHD
- Registration Number
- NCT00223561
- Lead Sponsor
- Utrecht Institute for Pharmaceutical Sciences
- Brief Summary
The primary purpose of this study is to determine the effects of methylphenidate versus placebo on driving ability of adult ADHD patients.
- Detailed Description
This study was set-up to examine the controversial issue whether or not it is safe to drive a car or not when treated with methylphenidate.
On-the-road driving tests during normal traffic are conducted to determine the effects of methylphenidate versus placebo on driving ability of adult ADHD patients.In addition, two laboratory tests are conducted to examine memory functioning and inhibitory control.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
- adult ADHD patient over 21 years old
- valid driver's license for at least 3 years
- treated with methylphenidate
- written informed consent
Exclusion Criteria
- use of illicit drugs
- use of drugs or having medical conditions known to affect driving ability
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Driving test:Standard Deviation of Lateral Position (SDLP, cm);i.e. the weaving of the car [single dose effects]
- Secondary Outcome Measures
Name Time Method Other Driving test parameters: Standard Deviation of Speed, mean speed, mean lateral position. Memory test: immediate & delayed word recall, delayed recognition.[single dose effects] Continuous Performance test: RT, %errors [single dose effects]
Trial Locations
- Locations (1)
Utrecht Institute for Pharmaceutical Sciences
🇳🇱Utrecht, Netherlands