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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-001855-20-NL

Enrollment

Registered

2008-06-23

Start date

2009-02-03

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Strattera Pharmaceutical Form: Capsule, hard INN or Proposed INN: Atomoxetine hydrochloride CAS Number: 82248597 Other descriptive name: Strattera Concentration unit: mg milligram(s) Conce

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026