NCT00572026

Brief Summary

Among children, attention-deficit/hyperactivity disorder (ADHD) is associated with an increased risk for accidents, especially bicycle and pedestrian (Leibson 2001; Jensen 1988; DiScala 1998). Anywhere from 40% to 80% of children diagnosed with ADHD continue to display symptoms of the disorder into adolescence(Barkley 1990; Gittelman 1985). Adolescents with ADHD are also at an increased risk for driving-related accidents, being 2 to 4 times more likely to experience a motor vehicle accident (Barkley 1993; Barkley 1996; Cox 2000), 4 times as likely to be at fault in the accident (Barkley 1993), and over 3 times more likely to incur associated injuries as a result of the accident(Murphy 1996). Stimulant treatment with immediate-release methylphenidate (IR MPH) has been demonstrated to improve driving performance in adolescents with ADHD. Hypothesis to be Tested:

  • Main study: Just as stimulant medication improves simulation and on-road driving performance of ADHD teenagers, it is hypothesized that stimulant medication will improve routine driving performance.
  • Substudy - Extended wear (15 hours) of Daytrana will lead to safer driving late in the evening (22:00 and 01:00), when the most dangerous driving mishaps are most likely to occur, and the next morning at 09:00.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

September 3, 2009

Status Verified

September 1, 2009

Enrollment Period

2 years

First QC Date

December 10, 2007

Last Update Submit

September 2, 2009

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention deficitHyperactivityAttention deficit hyperactivity disorder

Outcome Measures

Primary Outcomes (1)

  • Video recording of driving mishaps

    6 months

Study Arms (2)

1

EXPERIMENTAL

Daytrana

Drug: Methylphenidate Transdermal System

2

NO INTERVENTION

No treatment for ADHD

Interventions

Methylphenidate Transdermal SystemDRUG

Daytrana wear time up to 15 hours

Also known as: Brand name = Daytrana
1

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ADHD diagnosis
  • Valid driver's license
  • Not taking any medication for their ADHD
  • Have access to a car of which they are the primary driver
  • Have a history of approximately two driving collisions or citations
  • Have a history of responsiveness to methylphenidate

You may not qualify if:

  • Older than 25 years of age
  • Bi-polar disease
  • Psychosis
  • Satisfy the DSM IV criteria of active depressive or anxiety disorders
  • Have any medical condition that might impair driving or be contra-indicated for the use of methylphenidate
  • Pregnant or intending to get pregnant for the duration of the study,breastfeeding or intending to breastfeed for the duration of the study
  • Have skin allergies or skin condition that could be exacerbated by wearing the medication patch
  • Have documented allergy, hypersensitivity, or intolerance to methylphenidate
  • Have documented hypersensitivity to the Daytrana® adhesive backing
  • Have (history of):
  • seizures (except febrile seizure in infancy)
  • liver or renal disease
  • glaucoma
  • chronic skin conditions or contact sensitivities
  • current symptoms suggestive of cardiac disease
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivitySpasm

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel J Cox, PhD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel J Cox, PhD

CONTACT

434-924-5314djc4f@virginia.edu

Margaret Davis

CONTACT

434-924-0481mtd5m@virginia.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 2007

First Posted

December 12, 2007

Study Start

July 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

September 3, 2009

Record last verified: 2009-09

Locations

US(1)