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

NCT ID: NCT00223561

Last Updated: 2006-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2006-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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methylphenidate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Utrecht Institute for Pharmaceutical Sciences

OTHER

Sponsor Role lead

Principal Investigators

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Joris Verster, PhD

Role: PRINCIPAL_INVESTIGATOR

Utrecht Institute for Pharmaceutical Sciences

Edmund Volkerts, PhD

Role: STUDY_DIRECTOR

Utrecht Institute for Pharmaceutical Sciences

Locations

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Utrecht Institute for Pharmaceutical Sciences

Utrecht, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 20645078 (View on PubMed)

Other Identifiers

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02/021

Identifier Type: -

Identifier Source: org_study_id