Attention Deficit Hyperactivity Disorder
Conditions
Keywords
ADHD, adults, driving performance, atomoxetine
Brief summary
According available data individuals with ADHD are impaired in their driving ability which can be improved by stimulant medication. The impact of the specific noradrenalin-reuptake-inhibitor atomoxetine on driving ability of patients with ADHD has never been studied so far. The present study aims to evaluate the effects of atomoxetine treatment in patients with ADHD on practical driving abilities which will be assessed with a standardized driving test, a structured one-week driving diary and driving related neuropsychological processing especially different aspects of attention and executive functions which will be assessed with a neuropsychological test battery designed for the assessment of drivers fitness. A functional magnetic resonance imaging (fMRI) - investigation will also be performed at the beginning and after a 10-week treatment with atomoxetine. The study will be conducted in a single-blind placebo controlled parallel group design in cooperation of the academic Adult ADHD-outpatient clinics of the Central Institute of Mental Health, Mannheim and the Institute of Legal and Traffic Medicine of the University of Heidelberg, Germany. It is expected that treatment with atomoxetine will improve practical driving abilities and driving related neuropsychological processing. It is expected that risk taking and impulsive decision making will be reduced and sustained attention and overview of complex traffic situations will be improved while driving.
Interventions
DRUGAtomoxetine
40-80 mg atomoxetine once daily, including titration 10 weeks
Sponsors
Heidelberg University
Central Institute of Mental Health, Mannheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Informed Consent Form signed by the patients. 2. Patients are 16-50 years of age when the informed consent document is obtained (Visit 1). 3. Patients have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including venipuncture and examinations, required by the protocol. 4. Patients must meet DSM-IV-TR criteria for ADHD assessed by the Conners' Adult ADHD Diagnostic Interview for DSM-IV (CAADID) and KIDDIE-SADDS-PL respectively and according to expert consensus. 5. Patients must also have a significant other evaluation of their current ADHD using the Conners' Adult ADHD Rating Scale Observer: Screening Version (CAARS-O: SV) and Conners' Rating Scales- Revised (CRS-R):SV respectively 6. Patients must have a CGI-ADHD-S score of more than 4 points (moderate symptoms) at Visit 1. 7. Patients aged 18 and older must have a valid driver's license. 8. Patients must have laboratory results assessed at Visit 1, including serum chemistries, haematology, and thyroid function, that show no significant abnormalities. Significant would include laboratory deviations requiring acute medical intervention or further medical evaluation. 9. Patients must have a negative urinary drug screen at Visit 1. 10. Patients must have no medical history of heart disease that could be destabilized by increases in heart rate or blood pressure. The screening electrocardiogram (ECG) performed at Visit 1 must not show significant abnormalities. Significant would include a heart rate of less than 40 bpm and more than 120 bpm respectively, any disturbances in rhythm and conduction as well as ECG-findings pointing to myocardial infarction. 11. Females of childbearing potential defined as women not surgically sterilized and between menarche and 1 year post-menopause must test negative for pregnancy at Visit 1 based on an urinary pregnancy test and agree to use a reliable method of birth control (e.g., oral contraceptives, a reliable barrier method of birth control like diaphragms, intrauterine devices; partner with vasectomy or abstinence) during the study.
Exclusion criteria
* The
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standardized practical driving test | 1/2010 |
Secondary
| Measure | Time frame |
|---|---|
| Action-Reaction-Test Battery | 1/2010 |
| Performance criteria for drivers' fitness according to the Guidelines of Driver Fitness | 1/2010 |
| Safety measures including vital signs, laboratory test, ECG, assessment of SAEs | 1/2010 |
Countries
Germany
Outcome results
None listed