Clinical trial NCT00162968: Escitalopram as a Treatment for Pain in Polyneuropathy
Official title: Escitalopram as a Treatment for Pain in Polyneuropathy. A Double-Blind, Randomized, Placebo Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Polyneuropathies
Keywords: polyneuropathies
pain
drug effects
escitalopram
serotonin uptake inhibitors
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: H. Lundbeck A/S
First posted: 2005-09-13
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: pain relief
Secondary outcomes:
measure: effect on total pain and different subtypes of pain
measure: effect on quantitative sensory testing
measure: effect on pain related sleep disturbances
measure: effect on quality of life
measure: to determine if depression before treatment predicts an eventual pain relieving effect of escitalopram
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Danish Pain Research Center, Aarhus University Hospital, Noerrebrogade 44
city: Odense
country: Denmark
facility: Dept. of Neurology, Odense University Hospital, Sdr. Boulevard 29
Study officials:
affiliation: Odense University Hospital, Dept. of neurology
name: Soeren H Sindrup, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burke WJ. Escitalopram. Expert Opin Investig Drugs. 2002 Oct;11(10):1477-86. doi: 10.1517/13543784.11.10.1477.
citation: Sindrup SH, Jensen TS. Pharmacologic treatment of pain in polyneuropathy. Neurology. 2000 Oct 10;55(7):915-20. doi: 10.1212/wnl.55.7.915.
citation: Woolf CJ, Mannion RJ. Neuropathic pain: aetiology, symptoms, mechanisms, and management. Lancet. 1999 Jun 5;353(9168):1959-64. doi: 10.1016/S0140-6736(99)01307-0.
citation: Mork A, Kreilgaard M, Sanchez C. The R-enantiomer of citalopram counteracts escitalopram-induced increase in extracellular 5-HT in the frontal cortex of freely moving rats. Neuropharmacology. 2003 Aug;45(2):167-73. doi: 10.1016/s0028-3908(03)00138-2.