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Cipralex in Treatment of Depressive Symptoms and Chronic Back Pain
This study is currently recruiting participants.
Verified by Martin-Luther-Universität Halle-Wittenberg, June 2008
Sponsored by: Martin-Luther-Universität Halle-Wittenberg
Information provided by: Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT00227292
  Purpose

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
Low Back Pain
Depression
Drug: Escitalopram
Drug: Placebo
Phase IV

MedlinePlus related topics: Back Pain Depression
Drug Information available for: Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate
U.S. FDA Resources
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

Further study details as provided by Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Personality traits do not have a significant influence on outcome regarding depressive traits, pain intensity and functioning. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Personality disorders are significantly influencing worse outcome regarding depressive traits, pain intensity and functioning. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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
A, 2, II: Placebo Comparator
Placebo 10mg per day for the first week, then 20mg per day till the end of study.
Drug: Placebo
Placebo 10mg per day for the first week, then 20mg per day till the end of study.
A, 1: Experimental
Escitalopram 10mg per day for the first week, then 20mg per day till the end of study.
Drug: Escitalopram
Escitalopram 10mg per day for the first week, then 20mg per day till the end of study.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00227292

Contacts
Contact: Ulrich W Preuss, MD +49345557 ext 4595 ulrich_preuss@hotmail.com
Contact: Jessica Wong, MD +493456922 ext 145 wong_preuss@hotmail.com

Locations
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            
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
Investigators
Principal Investigator: Ulrich W Preuss, MD Krankenhaus Bethanien gGmbH
  More Information

Publications of Results:
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

Keywords provided by Martin-Luther-Universität Halle-Wittenberg:
Low back pain
Depression

Study placed in the following topic categories:
Depression
Low Back Pain
Pain
Depressive Disorder
Back Pain
Citalopram
Serotonin
Behavioral Symptoms
Signs and Symptoms
Mental Disorders
Mood Disorders
Neurologic Manifestations
Dexetimide

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009