Efficacy of Antidepressants in Chronic Back Pain
Information source: Department of Veterans Affairs
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Back Pain
Intervention: cognitive behavioral therapy (Behavioral); desipramine hydrochloride (Drug); cognitive behavioral therapy (Behavioral); benztropine mesylate 0.125 mg daily (Drug); desipramine hydrochloride (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Department of Veterans Affairs Official(s) and/or principal investigator(s):
Joseph H. Atkinson, MD, Principal Investigator, Affiliation: VA San Diego Healthcare System, San Diego
Overall contact:
Shetal Patel, PhD, Phone: (858) 642-3830, Email: backpainresearch@vapop.ucsd.edu
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.
Clinical Details
Official title: Efficacy of Antidepressants in Chronic Back Pain
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Descriptor Differential Scale of pain intensity
Secondary outcome: Roland and Morris Disability
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Chronic back pain (daily pain for > 6 months)
Exclusion Criteria:
- Major medical conditions which might contraindicate antidepressant treatment
Locations and Contacts
Shetal Patel, PhD, Phone: (858) 642-3830, Email: backpainresearch@vapop.ucsd.edu
VA San Diego Healthcare System, San Diego, San Diego, California 92161, United States; Recruiting
Janet M Peyton, MA MA, Phone: 858-642-3657, Email: janet.peyton@va.gov
Gerhard Schulteis, PhD, Phone: (858) 642-3657, Email: gerhard.schulteis@va.gov
Joseph H. Atkinson, MD, Principal Investigator
Additional Information
Starting date: January 2010
Last updated: October 15, 2012
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