Overview

This trial has been completed.

Condition back pain
Treatments cognitive behavioral therapy, desipramine hydrochloride, benztropine mesylate 0.125 mg daily
Phase phase 2
Sponsor VA Office of Research and Development
Collaborator University of California, San Diego
Start date January 2010
End date December 2014
Trial size 142 participants
Trial identifier NCT00964886, NURA-019-09S

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
desipramine hydrochloride
desipramine hydrochloride Anafranil
desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
(Experimental)
cognitive behavioral therapy
cognitive behavioral therapy
cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life
(Experimental)
desipramine hydrochloride and cognitive behavioral therapy
desipramine hydrochloride Anafranil
desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
cognitive behavioral therapy
cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life
(Placebo Comparator)
anticholinergic medication; active placebo
benztropine mesylate 0.125 mg daily Cogentin
benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride

Primary Outcomes

Measure
Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity
time frame: 12 weeks after baseline (or last observation carried forward)

Secondary Outcomes

Measure
Roland and Morris Disability Questionnaire
time frame: 12 weeks after baseline (or last observation carried forward)

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Chronic back pain (daily pain for > 6 months) Exclusion Criteria: - Major medical conditions which might contraindicate antidepressant treatment

Additional Information

Official title Efficacy of Antidepressants in Chronic Back Pain
Principal investigator Joseph H Atkinson, MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by VA Office of Research and Development.