Efficacy of Antidepressants in Chronic Back Pain

Phase 2

Completed

• Conditions: Back Pain
• Interventions: Drug: desipramine hydrochloride; Drug: benztropine mesylate 0.125 mg daily; Behavioral: cognitive behavioral therapy

• Registration Number: NCT00964886
• Lead Sponsor: VA Office of Research and Development

Brief 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.

Detailed 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).

Study Timeline

• Study First Submitted: 2009-08-24
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-25
• Study Start: 2010-01
• Primary Completion: 2014-12
• Study Completion: 2015-12
• Status Verified: 2016-11
• Results First Submitted: 2016-11-23
• Results First Submitted QC: 2016-11-23
• Last Update Submitted: 2016-11-23
• Results First Posted: 2016-11-29
• Last Update Posted: 2016-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

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

Exclusion Criteria

• Major medical conditions which might contraindicate antidepressant treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3	desipramine hydrochloride	desipramine hydrochloride and cognitive behavioral therapy
Arm 4	benztropine mesylate 0.125 mg daily	anticholinergic medication; active placebo
Arm 3	cognitive behavioral therapy	desipramine hydrochloride and cognitive behavioral therapy
Arm 1	desipramine hydrochloride	desipramine hydrochloride
Arm 2	cognitive behavioral therapy	cognitive behavioral therapy

Primary Outcome Measures

Name	Time	Method
Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity	12 weeks after baseline (or last observation carried forward)	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.

Secondary Outcome Measures

Name	Time	Method
Roland and Morris Disability Questionnaire	12 weeks after baseline (or last observation carried forward)	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.

Trial Locations

Locations (1)

VA San Diego Healthcare System, San Diego, CA; 🇺🇸 San Diego, California, United States