NCT Number: NCT00162968
Escitalopram as a Treatment for Pain in Polyneuropathy
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.
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Notify MeKey information
Conditions
Age range
20 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Danish Pain Research Center, Aarhus University Hospital, Noerrebrogade 44, Aarhus, Denmark
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
pain relief
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
Odense University Hospital
Other
Collaborators
- Aarhus University Hospital
- H. Lundbeck A/S
Registry information
Official study title
Escitalopram as a Treatment for Pain in Polyneuropathy. A Double-Blind, Randomized, Placebo Controlled Trial.
Important dates
- Study start
- 2004
- Study completion
- 2007
- First posted
- Sep 13, 2005
- Registry last updated
- Apr 24, 2007
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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