- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00162968
Escitalopram as a Treatment for Pain in Polyneuropathy
Escitalopram as a Treatment for Pain in Polyneuropathy. A Double-Blind, Randomized, Placebo Controlled Trial.
Study Overview
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.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Aarhus, Denmark, 8000
- Danish Pain Research Center, Aarhus University Hospital, Noerrebrogade 44
-
Odense, Denmark, 5000
- Dept. of Neurology, Odense University Hospital, Sdr. Boulevard 29
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
pain relief
|
Secondary Outcome Measures
Outcome Measure |
---|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Soeren H Sindrup, MD, PhD, Odense University Hospital, Dept. of neurology
Publications and helpful links
General Publications
- Burke WJ. Escitalopram. Expert Opin Investig Drugs. 2002 Oct;11(10):1477-86. doi: 10.1517/13543784.11.10.1477.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Polyneuropathies
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Citalopram
Other Study ID Numbers
- escit01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
Clinical Trials on escitalopram
-
First Affiliated Hospital of Zhejiang UniversityRecruitingAdolescent | Depressive DisorderChina
-
Perry RenshawTerminatedDepression | Substance Use | Dual DiagnosisUnited States
-
University of NebraskaRecruiting
-
Rigshospitalet, DenmarkUniversity of Cambridge; Lundbeck FoundationCompleted
-
Ryerson UniversityUnknownInsomnia | Major Depressive DisorderCanada
-
Centre Hospitalier Universitaire VaudoisNot yet recruitingPharmacogenetic Testing
-
Shanghai 7th People's HospitalNot yet recruitingDepressive Disorder, MajorChina
-
Shanghai Mental Health CenterJiangsu Nhwa Pharmaceutical Co., Ltd.Completed
-
Shanghai Mental Health CenterRecruiting
-
University of PennsylvaniaWashington University School of MedicineCompleted