ICADTS class III medication and fitness to drive
Phase 1
- Conditions
- Depression, anxiety, sleep disordersTherapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]
- Registration Number
- EUCTR2013-004936-31-NL
- Lead Sponsor
- Ministry of Infrastructure and the Environment
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Patients: chronic use of ICADTS class III medication (> 6 months)
- age between 21 and 75 (inclusive)
- BMI between 19 an 29 m2/kg (inclusive)
- in posession of a valid drivers license for at least 3 years
- driving experience of at least 3000 km/yeat on average
- sufficient vision
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140
Exclusion Criteria
- a neurological disorder
- use of drugs
- excessive alcohol consumption (> 21 glasses of alcohol/week)
- smoking (> 10 cigarettes/day)
- pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method