search
Back to results

Effects of Amitriptyline for the Treatment of Pain on Driving Performance and Cognition.

Primary Purpose

Chronic Neuropathic Pain

Status
Terminated
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
amitriptyline
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Neuropathic Pain focused on measuring neuropathic pain, erp, driving, attention, amitriptyline

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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, right-handed Exclusion Criteria: psychological or physical disorder other than pain(-related), other psychotropic medication use, excessive drinking or smoking, alcohol- or drug dependence, illigal drug use

Sites / Locations

  • University of Utrecht

Outcomes

Primary Outcome Measures

driving parameters

Secondary Outcome Measures

laboratory task parameters
ERPs

Full Information

First Posted
September 12, 2005
Last Updated
September 12, 2005
Sponsor
UMC Utrecht
Collaborators
Utrecht University
search

1. Study Identification

Unique Protocol Identification Number
NCT00189059
Brief Title
Effects of Amitriptyline for the Treatment of Pain on Driving Performance and Cognition.
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 Type
Interventional

2. Study Status

Record Verification Date
April 2005
Overall Recruitment Status
Terminated
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
UMC Utrecht
Collaborators
Utrecht University

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neuropathic Pain
Keywords
neuropathic pain, erp, driving, attention, amitriptyline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
24 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
amitriptyline
Primary Outcome Measure Information:
Title
driving parameters
Secondary Outcome Measure Information:
Title
laboratory task parameters
Title
ERPs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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, right-handed Exclusion Criteria: psychological or physical disorder other than pain(-related), other psychotropic medication use, excessive drinking or smoking, alcohol- or drug dependence, illigal drug use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edmund Volkerts, PhD
Organizational Affiliation
University of Utrecht, department of Psychopharmacology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utrecht
City
Utrecht
ZIP/Postal Code
3508 TB
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

Effects of Amitriptyline for the Treatment of Pain on Driving Performance and Cognition.

We'll reach out to this number within 24 hrs