The effects of atomoxetine on brain potentials in response to auditory distracting sounds during driving in adults with attention-deficit hyperactivity disorder.

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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24935

Enrollment

Registered

2009-11-11

Start date

2009-09-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

ADHD, atomoxetine, electroencephalography (EEG), event-related potential (ERP), attention, inhibition

Interventions

1. Atomoxetine

2. Placebo.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult men and women diagnosed with ADHD (DSM IV, APA 1994), aged 21-55 years; 2. Written informed consent; 3. Possession of a valid driver’s license for at least 3 years; 4. For women of childbearing potential, a negative urine beta-HCG pregnancy test result at test days; 5. Normal static binocular acuity, corrected or uncorrected; 6. Normal hearing; 7. Be considered as reliable and mentally capable of adhering to the protocol.

Exclusion criteria

Exclusion criteria: 1. Depression or anxiety disorder, unless controlled and stable with medication (SSRI); 2. IQ<75; 3. Current drug use (positive urine drug screen on the presence of amphetamines (including MDMA), barbiturates, benzodiazepines, cocaine, and opiates at test days); 4. Use of psychoactive medication, except SSRI; 5. Positive alcohol breath test; 6. Prior enrolment in the same study; 7. Participation in another clinical trial.

Design outcomes

Primary

Measure	Time frame
Primary outcome measures are: The weaving of the car during the driving test, i.e. the Standard Deviation of Lateral Position (SDLP), the P3a measured in an auditory oddball task which is suggested to reflect attention orienting/distraction, and the stop signal reaction time and P3 measured in a stop task which is suggested to be associated with response inhibition.	—

Secondary

Measure	Time frame
Secondary outcome measures are: Mean speed, meen lateral position, and Standard Deviation of Speed (SDS) for the driving test. Mismatch negativity (MMN), P3b and reorienting negativity (RON), reaction times, false alarms, and misses for the auditory oddball task. N1, mean reaction time, reaction time variability, percentage correctly inhibited, percentage errors, and percentage ommisions in the stop task.	—

Measure

Time frame

Secondary outcome measures are: Mean speed, meen lateral position, and Standard Deviation of Speed (SDS) for the driving test. Mismatch negativity (MMN), P3b and reorienting negativity (RON), reaction times, false alarms, and misses for the auditory oddball task. N1, mean reaction time, reaction time variability, percentage correctly inhibited, percentage errors, and percentage ommisions in the stop task.

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Contacts

Public ContactA.E. Wester

Utrecht Institute for Pharmaceutical Sciences, Utrecht University

A.E.Wester@uu.nl+31(0)302537768

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)