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Cipralex in Treatment of Depressive Symptoms and Chronic Back Pain

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ClinicalTrials.gov Identifier: NCT00227292
Recruitment Status : Withdrawn (Mutual agreement between Sponsor and Investigator.)
First Posted : September 28, 2005
Last Update Posted : June 17, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Preuss, Martin-Luther-Universität Halle-Wittenberg

Tracking Information
First Submitted Date  ICMJE September 26, 2005
First Posted Date  ICMJE September 28, 2005
Last Update Posted Date June 17, 2014
Study Start Date  ICMJE November 2007
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2007)
In comparison to placebo-treated patients, patients with treated with Cipralex report a significant reduction in depressive symptoms (>= 50% HAMD score) after 4 weeks of treatment. [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2005)
In comparison to placebo-treated patients, patients with treated with Cipralex report a significant reduction in depressive symptoms (>= 50% HAMD score) after 4 weeks of treatment.
Change History Complete list of historical versions of study NCT00227292 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2007)
  • In comparison to placebo, subjects treated with Cipralex report a significant reduction in pain intensity (>= 50% reduction of pain questionnaire score or VAS) after 12 weeks of treatment. [ Time Frame: 12 weeks ]
  • In comparison with placebo, subjects treated with Cipralex report a significant improvement in physical and everyday functioning after 12 weeks of treatment. [ Time Frame: 12 weeks ]
  • Personality traits do not have a significant influence on outcome regarding depressive traits, pain intensity and functioning. [ Time Frame: 12 weeks ]
  • Personality disorders are significantly influencing worse outcome regarding depressive traits, pain intensity and functioning. [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2005)
  • In comparison to placebo, subjects treated with Cipralex report a significant reduction in pain intensity (>= 50% reduction of pain questionnaire score or VAS) after 12 weeks of treatment.
  • In comparison with placebo, subjects treated with Cipralex report a significant improvement in physical and everyday functioning after 12 weeks of treatment.
  • Personality traits do not have a significant influence on outcome regarding depressive traits, pain intensity and functioning.
  • Personality disorders are significantly influencing worse outcome regarding depressive traits, pain intensity and functioning.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cipralex in Treatment of Depressive Symptoms and Chronic Back Pain
Official Title  ICMJE Cipralex in Treatment of Depressive Symptoms and Chronic Back Pain
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.

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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Low Back Pain
  • Depression
Intervention  ICMJE
  • Drug: Escitalopram
    Escitalopram 10mg per day for the first week, then 20mg per day till the end of study.
    Other Name: Cipralex
  • Drug: Placebo
    Placebo 10mg per day for the first week, then 20mg per day till the end of study.
Study Arms  ICMJE
  • Placebo Comparator: A, 2, II
    Placebo 10mg per day for the first week, then 20mg per day till the end of study.
    Intervention: Drug: Placebo
  • Experimental: A, 1
    Escitalopram 10mg per day for the first week, then 20mg per day till the end of study.
    Intervention: Drug: Escitalopram
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 15, 2014)
0
Original Enrollment  ICMJE
 (submitted: September 26, 2005)
106
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • In- and out-patients at KH Bethanien, Greifswald, presenting with non-specific chronic low back pain lasting longer than 6 months (assessed with VAS and OLBPQ rev.)
  • Age from 18 to 65 years
  • Depressive symptoms (HAMD scores >10)
  • Significant disability in daily living tasks (Owestry Disability Index >30%)
  • Medication with nonsteroidal anti-inflammatory drugs.

Exclusion Criteria:

  • Other significant Axis I disorders, including psychosis, eating disorders, substance use disorders or recent suicidal behavior.
  • Systemic inflammatory disorder, malignancy, other acute medical or neurological disorders, recent surgery within 12 months.
  • Medication with opioids, corticosteroids, other psychotropic medication except Temazepam.
  • History of gastric ulcer, gastritis or gastric bleeding.
  • Known allergy or intolerance to Citalopram or Cipralex.
  • Pregnant or lactating women.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00227292
Other Study ID Numbers  ICMJE EudraCT Nr.2005-001673-10
JOS 05/01 ( Other Identifier: Eudra )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Preuss, Martin-Luther-Universität Halle-Wittenberg
Study Sponsor  ICMJE Martin-Luther-Universität Halle-Wittenberg
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ulrich W Preuss, MD Krankenhaus Bethanien gGmbH
PRS Account Martin-Luther-Universität Halle-Wittenberg
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP