Cipralex in Treatment of Depressive Symptoms and Chronic Back Pain
NCT00227292 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL
Last updated 2014-06-17
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.
Conditions
- Low Back Pain
- Depression
Interventions
- DRUG
-
Escitalopram
Escitalopram 10mg per day for the first week, then 20mg per day till the end of study.
- DRUG
-
Placebo 10mg per day for the first week, then 20mg per day till the end of study.
Sponsors & Collaborators
-
Martin-Luther-Universität Halle-Wittenberg
lead OTHER
Principal Investigators
-
Ulrich W Preuss, MD · Krankenhaus Bethanien gGmbH
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-11-30
- Primary Completion
- 2012-11-30
- Completion
- 2012-11-30
Countries
- Germany
Study Locations
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