The aim of the study is to investigate the effects of atomoxetine on driving performance compared to placebo in 30 adult patients with ADHD. An auditory oddball paradigm will be presented and EEG will be measured during driving to gain insight in…
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Source
Brief title
Condition
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure of the driving test are standard deviation of lateral
position (SDLP), mean lateral position, standard deviation of speed (SDS), and
mean speed. The outcome measures of the auditory oddball task are reaction
speed, missers, false alarms, and reaction time variability. The outcome
measures of the EEG measured during presentation of the auditory oddball task
and during driving are ERPs (MMN, P3a, P3b, RON) and EEG power (Alpha, beta,
theta, delta). The main outcome measures of the stop signal task are the mean
reaction time (MRT) and stop signal reaction time (SSRT). The ERPs that will be
measured in response to the stop signal task are the P3 and N1.
Secondary outcome
N.A.
Background summary
Driving a car is an important factor in daily life. For patients that are
treated with methylphenidate it is often prohibited to drive a car in the
Netherlands. However, several studies have shown a positive effect of
methylphenidate in ADHD patients on driving performance and related tasks.
Since april 2005 a new treatment for ADHD is available, namely atomoxetine. The
effects of atomoxetine on driving ability have not been investigated yet.
Inattention and distraction of the driver is often the cause of traffic
accidents. ADHD patients have attention deficits and are easily distracted. To
gain more insight into the attentional processes during driving in ADHD
patients, and in the possible improvement with atomoxetine, we propose to study
attentional processes during driving with and without atomoxetine in adult ADHD
patients. This will be investigated by presentation of an auditory oddball
paradigm during driving and the measurement of event-related potentials (ERPs)
in reaction to these auditory stimuli.
Deficient inhibitory control is a core symptom of ADHD. Inhibitory control and
related ERPs improve after methylphenidate intake. Recently an improvement of
inhibitory control has also been found after intake of atomoxetine. To
replicate this study and to investigate the effects of atomoxetine on the ERPs
related to inhibitory control, a stop signal task will be performed and ERPs
will be recorded under influence of atomoxetine and placebo.
Study objective
The aim of the study is to investigate the effects of atomoxetine on driving
performance compared to placebo in 30 adult patients with ADHD. An auditory
oddball paradigm will be presented and EEG will be measured during driving to
gain insight in the attentional processes during driving in ADHD patients (with
atomoxetine and placebo). Furthermore, the effects of atomoxetine and placebo
on inhibitory control and related ERPs will be investigated.
Study design
Patients take part in the study for 2-3 weeks. Each patient will participate 3
days (approxamately 4 hours per day), including one training/screening day. The
study is a dubbel blind cross-over randomized study. Participation will include
performing an on-the-road driving test, an auditory oddball task, and
performing the on-the-road driving test while the auditory oddball task is
presented simultaneously. ERPs will be recorded in response to the auditory
oddball stimuli. Finally, a stop-signal-task will be performed and ERPs will be
recorded in response to the stop-signal-task.
Intervention
Intervention consists out of one dosage atomoxetine and one dosage of placebo
on two different test days.
Study burden and risks
The risk for the patients is the risk of participating in normal traffic.
Driving with distracting stimuli can be an extra risk. The risk of driving in
normal traffic with distracting stimuli will be abolished by the presence of a
licensed driving instructor who is provided with a double brake and clutch
system and who can end the test if nescessary. Further, the risk for the
patient consists of intake of atomoxetine. However, atomoxetine is a registred
medicine prescribed for use in ADHD, abolishing the risk to a minimum. The
burden for the patients is delay of ADHD medication treatment for two weeks.
Sorbonnelaan 16
3584 CA Utrecht
NL
Sorbonnelaan 16
3584 CA Utrecht
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-001855-20-NL |
| CCMO | NL18258.041.08 |