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

Withdrawn

• Conditions: Attention Deficit Hyperactivity Disorder; 10009841; ADHD

• Registration Number: NL-OMON31557
• Lead Sponsor: niversiteit Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

-Adult men and women diagnosed with ADHD
-Written informed consent
-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

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, barbiturates, benzodiazepines, cocaine, and opiates at test days)
-Use of psychoactive medication
-Positive alcohol breath test
-Prior enrolment in the same study
-Participation in another clinical trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measure of the driving test are standard deviation of lateral<br /><br>position (SDLP), mean lateral position, standard deviation of speed (SDS), and<br /><br>mean speed. The outcome measures of the auditory oddball task are reaction<br /><br>speed, missers, false alarms, and reaction time variability. The outcome<br /><br>measures of the EEG measured during presentation of the auditory oddball task<br /><br>and during driving are ERPs (MMN, P3a, P3b, RON) and EEG power (Alpha, beta,<br /><br>theta, delta). The main outcome measures of the stop signal task are the mean<br /><br>reaction time (MRT) and stop signal reaction time (SSRT). The ERPs that will be<br /><br>measured in response to the stop signal task are the P3 and N1.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>N.A.</p><br>