No registrations found.
ID
Source
Health condition
ADHD, atomoxetine, electroencephalography (EEG), event-related potential (ERP), attention, inhibition
Sponsors and support
Faculty of Science
Department of Psychopharmacology
Faculty of Science
Department of Psychopharmacology
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
N/A
Study objective
N/A
Study design
Each measure is acquired twice, timepoint: 0 and 5-7 days.
Intervention
1. Atomoxetine;
2. Placebo.
A.E. Wester
Sorbonnelaan 16
Utrecht 3584 CA
The Netherlands
+31(0)302537768
A.E.Wester@uu.nl
A.E. Wester
Sorbonnelaan 16
Utrecht 3584 CA
The Netherlands
+31(0)302537768
A.E.Wester@uu.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1992 |
| NTR-old | NTR2109 |
| Other | METC Universiteit Utrecht : 08/225 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |