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Methylphenidate and Driving Ability in Adult Patients With Attention-Deficit Hyperactivity Disorder

A Double Blind, Placebo-Controlled Crossover Study to Determine the Effects of Methylphenidate on Driving Ability in Adult Patients With Attention-Deficit Hyperactivity Disorder

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00223561
Enrollment
18
Registered
2005-09-22
Start date
2003-02-28
Completion date
2006-02-28
Last updated
2006-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

Keywords

adult

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.

Interventions

DRUGmethylphenidate

Sponsors

Utrecht Institute for Pharmaceutical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Driving test:Standard Deviation of Lateral Position (SDLP, cm);i.e. the weaving of the car [single dose effects]

Secondary

MeasureTime frame
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]

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026