search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


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


- candidate number6711
- NTR NumberNTR2109
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-nov-2009
- Secondary IDs08/225 METC Universiteit Utrecht
- Public TitleThe effects of atomoxetine on brain potentials in response to auditory distracting sounds during driving in adults with attention-deficit hyperactivity disorder.
- Scientific TitleA 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.
- ACRONYM
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedADHD, Attention, Event-related potential (ERP)
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2009
- planned closingdate1-feb-2010
- Target number of participants30
- Interventions1. Atomoxetine;
2. Placebo.
- Primary outcomePrimary 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 outcomeSecondary 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.
- TimepointsEach measure is acquired twice, timepoint: 0 and 5-7 days.
- Trial web siteN/A
- statusopen: 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
- Funding
(Source(s) of Monetary or Material Support)
Utrecht Institute for Pharmaceutical Sciences, Utrecht University
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD11-nov-2009 - 25-nov-2009


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl