Effects of Amitriptyline for the Treatment of Pain on Driving Performance and Cognition.
Information source: UMC Utrecht
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Neuropathic Pain
Intervention: amitriptyline (Drug)
Phase: Phase 4
Sponsored by: UMC Utrecht
Official(s) and/or principal investigator(s):
Edmund Volkerts, PhD, Principal Investigator, Affiliation: University of Utrecht, department of Psychopharmacology
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
Official title: Effects of Pain and the Treatment of Pain With Amitriptyline on Driving Performance, Attentional Capacity and Psychomotor Performance in Chronic Neuropathic Pain Patients
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study
Primary outcome: driving parameters
laboratory task parameters
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.
Minimum age: 30 Years.
Maximum age: 60 Years.
- age, amitriptyline responder, adequately treated with amitriptyline in studied dose
before study participation, pain intensity score (VAS) of at least 4 cm on a 10 cm
scale, driving licence, driving experience, speak fluently Dutch, normal vision,
- psychological or physical disorder other than pain(-related), other psychotropic
medication use, excessive drinking or smoking, alcohol- or drug dependence, illigal
Locations and Contacts
University of Utrecht, Utrecht 3508 TB, Netherlands
Starting date: October 2002
Ending date: May 2005
Last updated: September 12, 2005