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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00189059
Recruitment Status : Terminated
First Posted : September 16, 2005
Last Update Posted : September 16, 2005
Sponsor:
Collaborator:
Utrecht University
Information provided by:
UMC Utrecht

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 16, 2005
Last Update Posted Date September 16, 2005
Study Start Date  ICMJE October 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
driving parameters
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • laboratory task parameters
  • ERPs
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Amitriptyline for the Treatment of Pain on Driving Performance and Cognition.
Official Title  ICMJE Effects of Pain and the Treatment of Pain With Amitriptyline on Driving Performance, Attentional Capacity and Psychomotor Performance in Chronic Neuropathic Pain Patients
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Chronic Neuropathic Pain
Intervention  ICMJE Drug: amitriptyline
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: September 12, 2005)
24
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE May 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00189059
Other Study ID Numbers  ICMJE 01/341-E
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE UMC Utrecht
Collaborators  ICMJE Utrecht University
Investigators  ICMJE
Principal Investigator: Edmund Volkerts, PhD University of Utrecht, department of Psychopharmacology
PRS Account UMC Utrecht
Verification Date April 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP