Efficacy of Antidepressants in Chronic Back Pain

November 23, 2016 updated by: VA Office of Research and Development
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

142

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92161
        • VA San Diego Healthcare System, San Diego, CA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Major medical conditions which might contraindicate antidepressant treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
desipramine hydrochloride
Drug: desipramine hydrochloride
desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
Other Names:
  • Anafranil
Experimental: Arm 2
cognitive behavioral therapy
Behavioral: cognitive behavioral therapy
cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life
Experimental: Arm 3
desipramine hydrochloride and cognitive behavioral therapy
Drug: desipramine hydrochloride
desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
Other Names:
  • Anafranil
Behavioral: cognitive behavioral therapy
cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life
Placebo Comparator: Arm 4
anticholinergic medication; active placebo
Drug: benztropine mesylate 0.125 mg daily
benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride
Other Names:
  • Cogentin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks after baseline (or last observation carried forward)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks after baseline (or last observation carried forward)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Collaborators

University of California, San Diego

Investigators

  • Principal Investigator: Joseph H Atkinson, MD, VA San Diego Healthcare System, San Diego, CA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 24, 2009

First Submitted That Met QC Criteria

August 24, 2009

First Posted (Estimate)

August 25, 2009

Study Record Updates

Last Update Posted (Estimate)

November 29, 2016

Last Update Submitted That Met QC Criteria

November 23, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NURA-019-09S

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Available in SPSS format from the investigators.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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