Attention Deficit Hyperactivity DisorderNCT01179386
Expectation of Driving Performance in Young Adults With ADHD Assessed by Driving Simulator and Seat Pressure Mapping
An observational study of Attention Deficit Hyperactivity Disorder, run by Meir Medical Center at 1 site in Israel.
Trial summary
Adolescents suffering of ADHD may have impaired driving performance. The investigators would like to check the differences in driving performance in young adults(aged: 15-18 years) with ADHD by driving simulator and seat pressure mapping with and without methylphenidate medication. Read more about this study
- Who is it for?
- Ages 15 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2011to Dec 2011
- Phase
- Observational
- 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 15 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 30 adolescents aged 15-18 years ,diagnosed as suffering from ADHD and being treated with a methylphenidate medication that is used in Israel 30 adolescents aged 15-18, without ADHD will the control group
Who may be able to join
- age 15-18 years Suffering from ADHD treated by methylphenidate before receiving driving license
Who cannot join
- any other neurological or psychiatric problem under treatment or investment adolescents who have driving license
Trial locations and contacts
1 site in 1 country.
About this study
Adolescents suffering of ADHD may have impaired driving performance. The investigators would like to check the differences in driving performance in young adults(aged: 15-18 years) with ADHD by driving simulator and seat pressure mapping with and without methylphenidate medication.
Read the detailed description
Adolescents with ADHD who are treated with one of the methylphenidate medication that is in use in Israel(Ritalin,Ritalin SR,Concerta,Ritalin LA)will be tested by driving simulator and seat pressure mapping by 2 stages: 1.when they are taking the medication that they are taking every day to control ADHD and: 2. without medication ( after 4 day washout period).
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- methylphenidate, ADHD, driving, simulator, pressure, adolescent
- 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.
| Study group | Role | What they receive |
|---|---|---|
| methylphenidate | 30 adolescents who are treated with Methylphenidate will perform the driving simulator and seat pressure mapping tests, in 2 different days : 1. with their regular methylphenidate medication and 2: without the methylphenidate medication after a 4 days washout period. Results will be recorded and statistical test will be performed. | |
| no medication | 30 adolescents : control group , not suffering from ADHD and without methylphenidate medication will perform the driving simulator and seat pressure mapping tests. Results will be recorded and statistical test will be performed. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startNov 2011
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
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 Attention Deficit Hyperactivity DisorderStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- cohen he avner, md, Principal investigator, sherute briut clalitrazon nava, Dr, Study director, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179386
- Sponsor's protocol ID
- hermanadhd
- Status last verified
- Aug 2011
- First submitted
- 9 Aug 2010
- Last updated
- 30 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Cox DJ, Humphrey JW, Merkel RL, Penberthy JK, Kovatchev B. Controlled-release methylphenidate improves attention during on-road driving by adolescents with attention-deficit/hyperactivity disorder. J Am Board Fam Pract. 2004 Jul-Aug;17(4):235-9. doi: 10.3122/jabfm.17.4.235.
PubMed 15243010
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expectation of Driving Performance in Young Adults With ADHD Assessed by Driving Simulator and Seat Pressure Mapping
- ClinicalTrials.gov ID
- NCT01179386
- Acronym / sponsor ID
- hermanadhd
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- methylphenidate, ADHD, driving, simulator, pressure, adolescent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 11 Aug 2010 (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.
Adolescents suffering of ADHD may have impaired driving performance. The investigators would like to check the differences in driving performance in young adults(aged: 15-18 years) with ADHD by driving simulator and seat pressure mapping with and without methylphenidate medication.
Detailed description
Adolescents with ADHD who are treated with one of the methylphenidate medication that is in use in Israel(Ritalin,Ritalin SR,Concerta,Ritalin LA)will be tested by driving simulator and seat pressure mapping by 2 stages: 1.when they are taking the medication that they are taking every day to control ADHD and: 2. without medication ( after 4 day washout period).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| methylphenidate | – | –30 adolescents who are treated with Methylphenidate will perform the driving simulator and seat pressure mapping tests, in 2 different days : 1. with their regular methylphenidate medication and 2: without the methylphenidate medication after a 4 days washout period. Results will be recorded and statistical test will be performed. |
| no medication | – | –30 adolescents : control group , not suffering from ADHD and without methylphenidate medication will perform the driving simulator and seat pressure mapping tests. Results will be recorded and statistical test will be performed. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 30 adolescents aged 15-18 years ,diagnosed as suffering from ADHD and being treated with a methylphenidate medication that is used in Israel 30 adolescents aged 15-18, without ADHD will the control group
Key inclusion criteria (1 listed)
- age 15-18 years Suffering from ADHD treated by methylphenidate before receiving driving license
Key exclusion criteria (1 listed)
- any other neurological or psychiatric problem under treatment or investment adolescents who have driving license
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2011.
- Background: PubMed 15243010Cox DJ, Humphrey JW, Merkel RL, Penberthy JK, Kovatchev B. Controlled-release methylphenidate improves attention during on-road driving by adolescents with attention-deficit/hyperactivity disorder. J Am Board Fam Pract. 2004 Jul-Aug;17(4):235-9. doi: 10.3122/jabfm.17.4.235.
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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.
cohen he avner, md principal investigator
sherute briut clalit
razon nava, Dr study director
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder, run by Meir Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Aug 2011. 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 Israel. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Cohen Herman, MD (972-3-9398200, hermanc@post.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01179386, 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 30 Aug 2011.