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Expectation of Driving Performance in Young Adults With ADHD Assessed by Driving Simulator and Seat Pressure Mapping

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01179386
First Posted: August 11, 2010
Last Update Posted: August 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Meir Medical Center
  Purpose
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.

Condition
Attention Deficit Hyperactivity Disorder

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Expectation of Driving Performance in Young Adults With ADHD Assessed by Driving Simulator and Seat Pressure Mapping

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01179386


Contacts
Contact: Dr Cohen Herman, MD 972-3-9398200 hermanc@post.tau.ac.il

Locations
Israel
Cohen Herman Avner
Petah-Tikva, Israel
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: cohen he avner, md sherute briut clalit
Study Director: razon nava, Dr Tel Aviv University
  More Information

Publications:
Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01179386     History of Changes
Other Study ID Numbers: hermanadhd
First Submitted: August 9, 2010
First Posted: August 11, 2010
Last Update Posted: August 30, 2011
Last Verified: August 2011

Keywords provided by Meir Medical Center:
methylphenidate
ADHD
driving
simulator
pressure
adolescent

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents


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