Cipralex in Treatment of Depressive Symptoms and Chronic Back Pain

NCT00227292 | Withdrawn Phase 4

• 2 other identifiers: EudraCT Nr.2005-001673-10JOS 05/01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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

Keywords

Low back pain; Depression

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (4)

• 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.

  12 weeks

• In comparison with placebo, subjects treated with Cipralex report a significant improvement in physical and everyday functioning after 12 weeks of treatment.

  12 weeks

• Personality traits do not have a significant influence on outcome regarding depressive traits, pain intensity and functioning.

  12 weeks

• Personality disorders are significantly influencing worse outcome regarding depressive traits, pain intensity and functioning.

  12 weeks

Study Arms (2)

A, 2, II

PLACEBO COMPARATOR

Placebo 10mg per day for the first week, then 20mg per day till the end of study.

Drug: Placebo

A, 1

EXPERIMENTAL

Escitalopram 10mg per day for the first week, then 20mg per day till the end of study.

Drug: Escitalopram

Interventions

Escitalopram DRUG

Escitalopram 10mg per day for the first week, then 20mg per day till the end of study.

Also known as: Cipralex

A, 1

Placebo DRUG

Placebo 10mg per day for the first week, then 20mg per day till the end of study.

A, 2, II

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Martin-Luther-Universität Halle-Wittenberg: lead

Study Sites (1)

Martin-Luther-University Halle

Halle, Saxony-Anhalt, 06097, Germany

Location

Related Publications (2)

• Dickens C, Jayson M, Sutton C, Creed F. The relationship between pain and depression in a trial using paroxetine in sufferers of chronic low back pain. Psychosomatics. 2000 Nov-Dec;41(6):490-9. doi: 10.1176/appi.psy.41.6.490.

  PMID: 11110112 RESULT

• Atkinson JH, Slater MA, Wahlgren DR, Williams RA, Zisook S, Pruitt SD, Epping-Jordan JE, Patterson TL, Grant I, Abramson I, Garfin SR. Effects of noradrenergic and serotonergic antidepressants on chronic low back pain intensity. Pain. 1999 Nov;83(2):137-45. doi: 10.1016/s0304-3959(99)00082-2.

  PMID: 10534584 RESULT

MeSH Terms

Conditions

Low Back Pain; Depression

Interventions

Escitalopram; Dexetimide

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Ulrich W Preuss, MD

  Krankenhaus Bethanien gGmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: September 26, 2005
• First Posted: September 28, 2005
• Study Start: November 1, 2007
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: June 17, 2014

Record last verified: 2014-06

Locations

DE (1)