A double blind placebo controlled crossover study to determine the effects of atomoxetine on event-related potentials in response to auditory oddball stimuli during an on-the-road driving test in adult patients with attention deficit hyperactivity disorder - Effects of atomoxetine on attention and driving in adult ADHD

• Conditions: The effects of atomoxetine on driving performance, attention and response inbihition are studied in adult patients with attention-deficit hyperactivity disorder

• Registration Number: EUCTR2007-001855-20-NL
• Lead Sponsor: Faculty of Social Sciences, Utrecht University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

-Adult men and women diagnosed with ADHD
-Possession of a valid driver's license for at least 3 years
-For women of childbearing potential, a negative urine beta-HCG pregnancy test result at test days
-Normal static binocular acuity, corrected or uncorrected
-Normal hearing
-Be considered as reliable and mentally capable of adhering to the protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Depression or anxiety disorder, unless controlled and stable with medication
-IQ<75
-Current drug use (positive urine drug screen on the presence of amphetamines (including MDMA), barbiturates, benzodiazepines, cocaine, and opiates)
-Use of psychoactive medication
-Positive alcohol breath test
-Prior enrolment in the same study
-Participation in another clinical trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effects of atomoxetine on driving ability and on attentional processes during driving in ADHD patients. ;Secondary Objective: Study the effect of atomoxetine on stop performance and ERPs related to inhibitory control;Primary end point(s): Improved driving performance (a.o. weaving of the car) with atomoxetine compared to placebo. Improvement in attention during driving as reflected in event-related potentials (ERPs) associated with inattention and attentional capacity with atomoxetine as opposed to placebo. Better inhibitory control with atomoxetine as measured with the stop-signal-task and related ERPs.