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

Utrecht Institute for Pharmaceutical Sciences1 site in 1 country18 target enrollmentFebruary 2003

ConditionsADHD

Drugsmethylphenidate

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: ADHD
Sponsor: Utrecht Institute for Pharmaceutical Sciences
Enrollment: 18
Locations: 1
Primary Endpoint: Driving test:Standard Deviation of Lateral Position (SDLP, cm);i.e. the weaving of the car [single dose effects]
Status: Completed
Last Updated: 20 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2003

End Date

February 2006

Last Updated

20 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Utrecht Institute for Pharmaceutical Sciences

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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]