Cipralex in Treatment of Depressive Symptoms and Chronic Back Pain

This study has been withdrawn prior to enrollment.
(Mutual agreement between Sponsor and Investigator.)
Sponsor:
Information provided by (Responsible Party):
Dr. Preuss, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:
NCT00227292
First received: September 26, 2005
Last updated: June 15, 2014
Last verified: June 2014
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cipralex in Treatment of Depressive Symptoms and Chronic Back Pain

Resource links provided by NLM:


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 ]

Enrollment: 0
Study Start Date: November 2007
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A, 2, II
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.
Experimental: A, 1
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.
Other Name: Cipralex

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Martin-Luther-University Halle
Halle, Sachsen-Anhalt, Germany, 06097
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
Investigators
Principal Investigator: Ulrich W Preuss, MD Krankenhaus Bethanien gGmbH
  More Information

Publications:
Responsible Party: Dr. Preuss, Prof., Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT00227292     History of Changes
Obsolete Identifiers: NCT00294333
Other Study ID Numbers: EudraCT Nr.2005-001673-10, JOS 05/01
Study First Received: September 26, 2005
Last Updated: June 15, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Back Pain
Depression
Depressive Disorder
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on August 20, 2014