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

February 28, 2006 updated by: Utrecht Institute for Pharmaceutical Sciences

A Double Blind, Placebo-Controlled Crossover Study to Determine the Effects of Methylphenidate on 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

18

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3508 TB
        • Utrecht Institute for Pharmaceutical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Utrecht Institute for Pharmaceutical Sciences

Investigators

  • Study Director: Edmund Volkerts, PhD, Utrecht Institute for Pharmaceutical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Study Completion

February 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

March 1, 2006

Last Update Submitted That Met QC Criteria

February 28, 2006

Last Verified

February 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02/021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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