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

Primary Purpose

ADHD

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
methylphenidate
Sponsored by
Utrecht Institute for Pharmaceutical Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for ADHD focused on measuring adult

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Utrecht Institute for Pharmaceutical Sciences

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Full Information

First Posted
September 13, 2005
Last Updated
February 28, 2006
Sponsor
Utrecht Institute for Pharmaceutical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00223561
Brief Title
Methylphenidate and Driving Ability in Adult Patients With Attention-Deficit Hyperactivity Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2006
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Utrecht Institute for Pharmaceutical Sciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
adult

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
18 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
methylphenidate
Primary Outcome Measure Information:
Title
Driving test:Standard Deviation of Lateral Position (SDLP, cm);i.e. the weaving of the car [single dose effects]
Secondary Outcome Measure Information:
Title
Other Driving test parameters: Standard Deviation of Speed, mean speed, mean lateral position.
Title
Memory test: immediate & delayed word recall, delayed recognition.[single dose effects]
Title
Continuous Performance test: RT, %errors [single dose effects]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joris Verster, PhD
Organizational Affiliation
Utrecht Institute for Pharmaceutical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edmund Volkerts, PhD
Organizational Affiliation
Utrecht Institute for Pharmaceutical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Utrecht Institute for Pharmaceutical Sciences
City
Utrecht
ZIP/Postal Code
3508 TB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
20645078
Citation
Verster JC, Bekker EM, Kooij JJ, Buitelaar JK, Verbaten MN, Volkerts ER, Olivier B. Methylphenidate significantly improves declarative memory functioning of adults with ADHD. Psychopharmacology (Berl). 2010 Oct;212(2):277-81. doi: 10.1007/s00213-010-1952-2. Epub 2010 Jul 20.
Results Reference
derived

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

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