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Sponsored by: |
Martin-Luther-Universität Halle-Wittenberg |
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Information provided by: | Martin-Luther-Universität Halle-Wittenberg |
ClinicalTrials.gov Identifier: | NCT00227292 |
Chronic low back pain (CLBP) is one of the most frequent forms of chronic pain and can result in significant functional impairment. This is often associated with major depression too. Previous research reported significant beneficial effects of antidepressant medication in alleviating depression and pain intensity. The aim of this study is to evaluate the efficacy of Escitalopram, a new kind of Selective Serotonin Reuptake Inhibitor (SSRI) in patients with CLBP in a prospective, randomized and double-blind clinical trial. The main hypothesis is:
-in comparison to placebo, subjects with CLBP and Cipralex report a significant reduction in depressive symptoms (>= 50% of HAMD questionnaire) after 4 weeks of treatment.
Condition | Intervention | Phase |
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Low Back Pain Depression |
Drug: Escitalopram Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Cipralex in Treatment of Depressive Symptoms and Chronic Back Pain |
Estimated Enrollment: | 106 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A, 2, II: Placebo Comparator
Placebo 10mg per day for the first week, then 20mg per day till the end of study.
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Drug: Placebo
Placebo 10mg per day for the first week, then 20mg per day till the end of study.
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A, 1: Experimental
Escitalopram 10mg per day for the first week, then 20mg per day till the end of study.
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Drug: Escitalopram
Escitalopram 10mg per day for the first week, then 20mg per day till the end of study.
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Pain is an unpleasant sensory and emotional experience. Chronic pain, including chronic low back pain, represents a major public health problem. Risk factors of chronicity of low back pain include high levels of psychological distress prior to or during the episode, premorbid association with work status or employment dissatisfaction, unemployment, poor self-rated health and low levels of physical activity. Other psychosocial features are poor social and educational status, previous sexual or physical abuse. Furthermore, mechanical strain on the spine from heavy lifting, repetitive lifting, twisting and vibration, including driving increase the risk. Static work postures, prolonged standing or walking, road traffic accidents and falls are also significantly related.While there is little evidence for a specific personality profile, stress, distress, anxiety, mood disorders and depression were consistently related to neck and back pain.
CLBP is associated with significant disability, functional impairment, high rates of psychiatric symptoms including anxiety and depression, and loss of other physical roles. These may produce social and functional problems, which include reduced earning capacity, unemployment and family disharmony. Chronic pain is also associated with loss of self confidence and self-esteem, leading to social withdrawal and social isolation. Men with CLBP have significantly higher lifetime rates of major depression, alcohol use disorder and major anxiety disorder. After age of pain onset, CLBP subjects had over 9 times the risk of developing major depression.
Depression is believed to be mediated by 5-HT and norepinephrine through the raphe nucleus and locus coeruleus projections to the cerebral cortex and forebrain limbic systems, whereas pain is believed to be mediated in part through descending 5-HT and norepinephrine pain pathways that provide inhibitory input to the dorsal horn neurons in the spinal cord. Global deficiences in 5-HT or norepinephrine neurotransmission would be predicted to affect both mood and pain thresholds, possibly accounting for the hgh comorbidity of painful symptoms in patients with depression.Accordingly, enhancement of both neurotransmitter or 5-HT alone would be expected both to improve symptoms of depression and to normalize pain thresholds.
In antidepressant treatment of CLBP, only 2 studies were published using SSRIs. One reported significantly higher pain intensity reduction in maprotilin group compared to paroxetine and placebo. The other showed no effect of paroxetine on depression or pain. Patients on SSRI, however, reduced the amount of analgesic medication.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ulrich W Preuss, MD | +49345557 ext 4595 | ulrich_preuss@hotmail.com |
Contact: Jessica Wong, MD | +493456922 ext 145 | wong_preuss@hotmail.com |
Germany, Sachsen-Anhalt | |
Martin-Luther-University Halle | Recruiting |
Halle, Sachsen-Anhalt, Germany, 06097 | |
Contact: Ulrich W Preuss, MD +49345557 ext 4595 ulrich_preuss@hotmail.com | |
Contact: Jessica Wong, MD +493456922 ext 145 wong_preuss@hotmail.com | |
Principal Investigator: Ulrich W. Preuss, MD |
Principal Investigator: | Ulrich W Preuss, MD | Krankenhaus Bethanien gGmbH |
Responsible Party: | Martin-Luther-Universität Halle ( Associate Prof. Dr. Ulrich Preuss ) |
Study ID Numbers: | EudraCT Nr.2005-001673-10, JOS 05/01 |
Study First Received: | September 26, 2005 |
Last Updated: | July 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00227292 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Low back pain Depression |
Depression Low Back Pain Pain Depressive Disorder Back Pain Citalopram Serotonin |
Behavioral Symptoms Signs and Symptoms Mental Disorders Mood Disorders Neurologic Manifestations Dexetimide |
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Anti-Dyskinesia Agents Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents |
Serotonin Uptake Inhibitors Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |