- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01179386
Expectation of Driving Performance in Young Adults With ADHD Assessed by Driving Simulator and Seat Pressure Mapping
August 27, 2011 updated by: Meir Medical Center
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.
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Petah-Tikva, Israel
- Cohen Herman Avner
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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
Description
Inclusion Criteria:
- age 15-18 years Suffering from ADHD treated by methylphenidate before receiving driving license
Exclusion Criteria:
- any other neurological or psychiatric problem under treatment or investment adolescents who have driving license
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: cohen he avner, md, sherute briut clalit
- Study Director: razon nava, Dr, Tel Aviv University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Anticipated)
December 1, 2011
Study Completion (Anticipated)
December 1, 2011
Study Registration Dates
First Submitted
August 9, 2010
First Submitted That Met QC Criteria
August 10, 2010
First Posted (Estimate)
August 11, 2010
Study Record Updates
Last Update Posted (Estimate)
August 30, 2011
Last Update Submitted That Met QC Criteria
August 27, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- hermanadhd
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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