Efficacy of Antidepressants in Chronic Back Pain

Back Pain Clinical Trial

Official title:

Efficacy of Antidepressants in Chronic Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00964886
• Other study ID #: NURA-019-09S
• Status: Completed
• Phase: Phase 2
• First received: August 24, 2009
• Last updated: November 23, 2016
• Start date: January 2010
• Est. completion date: December 2015

Study information

• Verified date: November 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This 12 week placebo controlled clinical trial tests the individual and combined effects of an antidepressant medication and cognitive behavioral therapy for chronic back pain.

Description:

This is a 4 arm 12 week randomized clinical trial comparing the efficacy of 1) low concentration desipramine (< 60 ng/ml); 2) cognitive behavioral therapy; 3) low concentration desipramine + cognitive behavioral therapy; and 4) placebo medication (benzotropine mesylate).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Chronic back pain (daily pain for > 6 months)

Exclusion Criteria:

• Major medical conditions which might contraindicate antidepressant treatment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain

Intervention

Behavioral:
• cognitive behavioral therapy
cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life

Drug:
• desipramine hydrochloride
desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml

Behavioral:
• cognitive behavioral therapy
cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life

Drug:
• benztropine mesylate 0.125 mg daily
benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride
• desipramine hydrochloride
desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity	The DDS is self-report measure of "current" pain intensity of chronic back pain. Participants rate pain on a 20 point scale as being greater or less intense relative to 12 adjectival descriptor words which serve as anchors (eg, greater or less than "faint," "moderate," "strong"). Scores range from 0 to 20 with higher scores indicating higher pain intensity. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline or last observation carried forward, after co-varying for baseline (pre-treatment) values.	12 weeks after baseline (or last observation carried forward)	No
Secondary	Roland and Morris Disability Questionnaire	This questionnaire measures disability in everyday function due to back pain. It is a 24-item checklist asking patients to endorse whether or not back pain limits activities they normally do (eg, "I stay at home most of the time because of my back"). Scores range from 0 to 24, with higher scores indicating greater disability in everyday function due to back pain. The analysis evaluated the 'as randomized' sample at 12 weeks after baseline, after co-varying for baseline (pre-treatment) values.	12 weeks after baseline (or last observation carried forward)	No