Back to resultsEfficacy of Antidepressants in Chronic Back Pain
Primary Purpose
Back Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cognitive behavioral therapy
desipramine hydrochloride
cognitive behavioral therapy
benztropine mesylate 0.125 mg daily
desipramine hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Back Pain focused on measuring chronic pain, back pain, antidepressants
Eligibility Criteria
Inclusion Criteria:
- Chronic back pain (daily pain for > 6 months)
Exclusion Criteria:
- Major medical conditions which might contraindicate antidepressant treatment
Sites / Locations
- VA San Diego Healthcare System, San Diego, CA
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm 4
Arm Description
desipramine hydrochloride
cognitive behavioral therapy
desipramine hydrochloride and cognitive behavioral therapy
anticholinergic medication; active placebo
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00964886
First Posted
August 24, 2009
Last Updated
November 23, 2016
Sponsor
VA Office of Research and Development
Collaborators
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT00964886
Brief Title
Efficacy of Antidepressants in Chronic Back Pain
Official Title
Efficacy of Antidepressants in Chronic Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
University of California, San Diego
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
chronic pain, back pain, antidepressants
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
desipramine hydrochloride
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
cognitive behavioral therapy
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
desipramine hydrochloride and cognitive behavioral therapy
Arm Title
Arm 4
Arm Type
Placebo Comparator
Arm Description
anticholinergic medication; active placebo
Intervention Type
Behavioral
Intervention Name(s)
cognitive behavioral therapy
Intervention Description
cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life
Intervention Type
Drug
Intervention Name(s)
desipramine hydrochloride
Other Intervention Name(s)
Anafranil
Intervention Description
desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
Intervention Type
Behavioral
Intervention Name(s)
cognitive behavioral therapy
Intervention Description
cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life
Intervention Type
Drug
Intervention Name(s)
benztropine mesylate 0.125 mg daily
Other Intervention Name(s)
Cogentin
Intervention Description
benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride
Intervention Type
Drug
Intervention Name(s)
desipramine hydrochloride
Other Intervention Name(s)
Anafranil
Intervention Description
desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
Primary Outcome Measure Information:
Title
Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity
Description
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.
Time Frame
12 weeks after baseline (or last observation carried forward)
Secondary Outcome Measure Information:
Title
Roland and Morris Disability Questionnaire
Description
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.
Time Frame
12 weeks after baseline (or last observation carried forward)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic back pain (daily pain for > 6 months)
Exclusion Criteria:
Major medical conditions which might contraindicate antidepressant treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph H Atkinson, MD
Organizational Affiliation
VA San Diego Healthcare System, San Diego, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Available in SPSS format from the investigators.
Citations:
PubMed Identifier
32068667
Citation
Gould HM, Atkinson JH, Chircop-Rollick T, D'Andrea J, Garfin S, Patel SM, Funk SD, Capparelli EV, Penzien DB, Wallace M, Weickgenanta AL, Slater M, Rutledge T. A randomized placebo-controlled trial of desipramine, cognitive behavioral therapy, and active placebo therapy for low back pain. Pain. 2020 Jun;161(6):1341-1349. doi: 10.1097/j.pain.0000000000001834.
Results Reference
derived
Learn more about this trial
Efficacy of Antidepressants in Chronic Back Pain
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