Trials / Terminated
TerminatedNCT00189059
Effects of Amitriptyline for the Treatment of Pain on Driving Performance and Cognition.
Effects of Pain and the Treatment of Pain With Amitriptyline on Driving Performance, Attentional Capacity and Psychomotor Performance in Chronic Neuropathic Pain Patients
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 24 (planned)
- Sponsor
- UMC Utrecht · Academic / Other
- Sex
- All
- Age
- 30 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
The acute and subchronic effects of amitriptyline were compared to placebo in a double-blind crossover randomized study on driving ability and driving-related skills in chronic neuropathic pain patients.It was hypothesized that nocturnally administered 25 mg amitriptyline might affect driving performance negatively after acute, but not after subchronic treatment.
Detailed description
The present study was designed to determine the effects of nocturnally administered 25 mg amitriptyline, compared to placebo, after single (Day 1, acute effects) and repeated (Day 15, subchronic effects) administration on driving performance in neuropathic pain patients. In addition to the on-the-road driving test, laboratory tests measuring driving-related skills were administered. Moreover, effects of amitriptlyine on an attentional capacity task were tested using Event-Related Potentials (ERPs). It was hypothesized that nocturnally administered 25 mg amitriptyline might affect driving performance negatively after acute, but not after subchronic treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | amitriptyline |
Timeline
- Start date
- 2002-10-01
- Completion
- 2005-05-01
- First posted
- 2005-09-16
- Last updated
- 2005-09-16
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT00189059. Inclusion in this directory is not an endorsement.