ADHDPhase 4NCT00223561
Methylphenidate and Driving Ability in Adult Patients With Attention-Deficit Hyperactivity Disorder
A Phase 4 study testing methylphenidate in people with ADHD, run by Utrecht Institute for Pharmaceutical Sciences at 1 site in Netherlands.
Trial summary
The primary purpose of this study is to determine the effects of methylphenidate versus placebo on driving ability of adult ADHD patients. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- ADHD
- What is being tested?
- methylphenidate
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2003to Feb 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- adult ADHD patient over 21 years old
- valid driver's license for at least 3 years
- treated with methylphenidate
- written informed consent
Who cannot join
- use of illicit drugs
- use of drugs or having medical conditions known to affect driving ability
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Utrecht Institute for Pharmaceutical Sciences
Utrecht, 3508 TB
About this study
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
The primary purpose of this study is to determine the effects of methylphenidate versus placebo on driving ability of adult ADHD patients.
Read the 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.
- Conditions
- ADHD
- Being tested
- methylphenidate
- Keywords
- adult
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylphenidateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Driving test:Standard Deviation of Lateral Position (SDLP, cm);i.e. the weaving of the car [single dose effects]
Secondary outcomes (3)
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]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startFeb 2003
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 18 participants
Sponsor and investigators
- Lead sponsor
- Utrecht Institute for Pharmaceutical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Joris Verster, PhD, Principal investigator, Utrecht Institute for Pharmaceutical SciencesEdmund Volkerts, PhD, Study director, Utrecht Institute for Pharmaceutical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223561
- Sponsor's protocol ID
- 02/021
- Status last verified
- Feb 2006
- First submitted
- 13 Sep 2005
- Last updated
- 1 Mar 2006
- Results posted
- No
Publications
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.
PubMed 20645078
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00223561
- Acronym / sponsor ID
- 02/021
- Conditions
- ADHD
- Keywords
- adult
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants
- Lead sponsor
- Utrecht Institute for Pharmaceutical SciencesUniversity, hospital or other
- Study start
- Feb 2003
- Study completion
- Feb 2006
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- adult ADHD patient over 21 years old
- valid driver's license for at least 3 years
- treated with methylphenidate
- written informed consent
Key exclusion criteria (2 listed)
- use of illicit drugs
- use of drugs or having medical conditions known to affect driving ability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylphenidate | Drug | – |
Primary outcome
Driving test:Standard Deviation of Lateral Position (SDLP, cm);i.e. the weaving of the car [single dose effects]
3 secondary outcomes
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]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2006.
- Derived from this study: PubMed 20645078Verster 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joris Verster, PhD principal investigator
Utrecht Institute for Pharmaceutical Sciences
Edmund Volkerts, PhD study director
Utrecht Institute for Pharmaceutical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing methylphenidate in people with ADHD, run by Utrecht Institute for Pharmaceutical Sciences at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Driving test:Standard Deviation of Lateral Position (SDLP, cm);i.e. the weaving of the car [single dose effects]. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00223561, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2006.