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Completed

NCT Number: NCT00223561

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

The primary purpose of this study is to determine the effects of methylphenidate versus placebo on driving ability of adult ADHD patients.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Utrecht Institute for Pharmaceutical Sciences

Utrecht, 3508 TB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylphenidate

Drug

Primary outcomes

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

Secondary outcomes

  1. Other Driving test parameters: Standard Deviation of Speed, mean speed, mean lateral position.

  2. Memory test: immediate & delayed word recall, delayed recognition.[single dose effects]

  3. Continuous Performance test: RT, %errors [single dose effects]

Sponsors and collaborators

Lead sponsor

Utrecht Institute for Pharmaceutical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2006
First posted
Sep 22, 2005
Registry last updated
Mar 1, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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