Cipralex in Treatment of Depressive Symptoms and Chronic Back Pain

• Status: Withdrawn
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg
• Treatments: Citalopram; Dexetimide

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.