Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227292
Status:
WITHDRAWN
Last Update Posted:
2014-06-17
First Post:
2005-09-26
Brief Title:
Cipralex in Treatment of Depressive Symptoms and Chronic Back Pain
Sponsor:
Martin-Luther-Universität Halle-Wittenberg
Organization:
Martin-Luther-Universität Halle-Wittenberg
Study Overview
Official Title:
Cipralex in Treatment of Depressive Symptoms and Chronic Back Pain
Status:
WITHDRAWN
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Mutual agreement between Sponsor and Investigator
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
-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
Detailed Description:
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 relatedWhile 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 depressionAccordingly 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
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 depressionAccordingly 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| JOS 0501 | OTHER | Eudra | None |