|- candidate number||6711|
|- NTR Number||NTR2109|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-nov-2009|
|- Secondary IDs||08/225 METC Universiteit Utrecht|
|- Public Title||The effects of atomoxetine on brain potentials in response to auditory distracting sounds during driving in adults with attention-deficit hyperactivity disorder.
|- Scientific Title||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.
|- Healt Condition(s) or Problem(s) studied||ADHD, Attention, Event-related potential (ERP)|
|- 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 driverís 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);|
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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2009|
|- planned closingdate||1-feb-2010|
|- Target number of participants||30|
|- Interventions||1. Atomoxetine;|
|- 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.
|- Timepoints||Each measure is acquired twice, timepoint: 0 and 5-7 days.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| A.E. Wester|
|- CONTACT for SCIENTIFIC QUERIES|| A.E. Wester|
|- Sponsor/Initiator ||Utrecht Institute for Pharmaceutical Sciences, Utrecht University|
(Source(s) of Monetary or Material Support)
|Utrecht Institute for Pharmaceutical Sciences, Utrecht University|
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||11-nov-2009 - 25-nov-2009|