Status:
WITHDRAWN
Cipralex in Treatment of Depressive Symptoms and Chronic Back Pain
Lead Sponsor:
Martin-Luther-Universität Halle-Wittenberg
Conditions:
Low Back Pain
Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 researc...
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 hig...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00227292
Start Date
November 1 2007
End Date
November 1 2012
Last Update
June 17 2014
Active Locations (1)
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1
Martin-Luther-University Halle
Halle, Saxony-Anhalt, Germany, 06097