Cipralex in Treatment of Depressive Symptoms and Chronic Back Pain

NCT00227292 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2014-06-17

No results posted yet for this study

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

Interventions

DRUG

Escitalopram

Escitalopram 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.

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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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00227292 on ClinicalTrials.gov