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

ADHD Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223561
• Other study ID #: 02/021
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: February 28, 2006
• Start date: February 2003
• Est. completion date: February 2006

Study information

• Verified date: February 2006
• Source: Utrecht Institute for Pharmaceutical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Drug:
• methylphenidate

Locations

Country	Name	City	State
Netherlands	Utrecht Institute for Pharmaceutical Sciences	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Utrecht Institute for Pharmaceutical Sciences

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Driving test:Standard Deviation of Lateral Position (SDLP, cm);i.e. the weaving of the car [single dose effects]
Secondary	Other Driving test parameters: Standard Deviation of Speed, mean speed, mean lateral position.
Secondary	Memory test: immediate & delayed word recall, delayed recognition.[single dose effects]
Secondary	Continuous Performance test: RT, %errors [single dose effects]