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Escitalopram as a Treatment for Pain in Polyneuropathy
This study has been completed.
Study NCT00162968   Information provided by Odense University Hospital
First Received: September 9, 2005   Last Updated: April 23, 2007   History of Changes

September 9, 2005
April 23, 2007
December 2004
 
pain relief
Same as current
Complete list of historical versions of study NCT00162968 on ClinicalTrials.gov Archive Site
  • effect on total pain and different subtypes of pain
  • effect on quantitative sensory testing
  • effect on pain related sleep disturbances
  • effect on quality of life
  • to determine if depression before treatment predicts an eventual pain relieving effect of escitalopram
  • a. effect on total pain and different subtypes of pain
  • b. effect on quantitative sensory testing
  • c. effect on pain related sleep disturbances
  • d. effect on quality of life
  • e. to determine if depression before treatment predicts an eventual pain relieving effect of escitalopram
 
Escitalopram as a Treatment for Pain in Polyneuropathy
Escitalopram as a Treatment for Pain in Polyneuropathy. A Double-Blind, Randomized, Placebo Controlled Trial.

Many people with polyneuropathy suffer from pain which is difficult to treat. Escitalopram is a relatively new drug used in the treatment of depression. Escitalopram’s action mechanism on the brain suggests that escitalopram also may have an effect on neuropathic pain. This study will test the efficacy of escitalopram in patients with painful polyneuropathy.

Tricyclic antidepressants appear to be the most efficacious treatment of painful polyneuropathy. However, these drugs are contraindicated in some patients and a substantial number of patients decline treatment due to side-effects. Therefore, effective drugs that are better tolerated are needed. Clinical and basic research has demonstrated that drugs with serotonergic action can alleviate neuropathic pain. Escitalopram increases serotonin concentration in the central nervous system, suggesting that it might be a potential alternative to current treatments of neuropathic pain. The aim of this study is to test if escitalopram would relieve painful polyneuropathy.

Comparisons: Treatment with 20 mg escitalopram daily will be compared in a cross-over design with placebo. Each treatment period will last 6 weeks. During the last week of each treatment period, the dose will be tapered.

Phase IV
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
  • Pain
  • Polyneuropathies
Drug: escitalopram
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
50
April 2007
 

Inclusion Criteria:

  • median total pain score at baseline week >=4 on a 10 point numerical rating scale
  • characteristic symptoms of polyneuropathy within at least 6 months
  • diagnosis confirmed by physical examination, neurophysiologic exam. and/or quantitative sensory testing
  • pain at least 4 of 7 days
  • fertile women are using anticonceptive

Exclusion Criteria:

  • other cause to pain than polyneuropathy
  • former allergic reactions on escitalopram
  • known adverse events on escitalopram
  • pregnancy or nursing
  • critical disease (terminal cancer, cardial incompensation or critical renal or lung disease)
  • treatment with monoamine oxidase inhibitors between the trial or 2 weeks before or after treatment with other antidepressants, antiepileptic agents or opioids
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00162968
 
escit01
Odense University Hospital
  • Aarhus University Hospital
  • H. Lundbeck A/S
Principal Investigator: Soeren H Sindrup, MD, PhD Odense University Hospital, Dept. of neurology
Odense University Hospital
April 2007

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