Clinical Trials Directory

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

TypeNameDescription
DRUGamitriptyline

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.