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OpenTrials
Completed

NCT Number: NCT00964886

Efficacy of Antidepressants in Chronic Back Pain

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.

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Key information

Conditions

Back Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Major medical conditions which might contraindicate antidepressant treatment

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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

desipramine hydrochloride

Drug

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

Other names: Anafranil

benztropine mesylate 0.125 mg daily

Drug

benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride

Other names: Cogentin

Primary outcomes

  1. Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity

    Time frame: 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 outcomes

  1. Roland and Morris Disability Questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • University of California, San Diego

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Aug 25, 2009
Registry last updated
Nov 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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