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Trial record 4 of 512 for:    ESCITALOPRAM AND Serotonin Uptake

Escitalopram as a Treatment for Pain in Polyneuropathy

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. Identifier: NCT00162968
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : April 24, 2007
Aarhus University Hospital
H. Lundbeck A/S
Information provided by:
Odense University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Polyneuropathies Drug: escitalopram Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Escitalopram as a Treatment for Pain in Polyneuropathy. A Double-Blind, Randomized, Placebo Controlled Trial.
Study Start Date : December 2004
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. pain relief

Secondary Outcome Measures :
  1. effect on total pain and different subtypes of pain
  2. effect on quantitative sensory testing
  3. effect on pain related sleep disturbances
  4. effect on quality of life
  5. to determine if depression before treatment predicts an eventual pain relieving effect of escitalopram

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00162968

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Danish Pain Research Center, Aarhus University Hospital, Noerrebrogade 44
Aarhus, Denmark, 8000
Dept. of Neurology, Odense University Hospital, Sdr. Boulevard 29
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Aarhus University Hospital
H. Lundbeck A/S
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Principal Investigator: Soeren H Sindrup, MD, PhD Odense University Hospital, Dept. of neurology

Layout table for additonal information Identifier: NCT00162968     History of Changes
Other Study ID Numbers: escit01
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: April 24, 2007
Last Verified: April 2007
Keywords provided by Odense University Hospital:
drug effects
serotonin uptake inhibitors
Additional relevant MeSH terms:
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Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents