Phase 2 N=142 Randomized Triple-blind Treatment

Efficacy of Antidepressants in Chronic Back Pain

Back Pain

Bottom Line

View on ClinicalTrials.gov: NCT00964886 ↗

Enrolled (actual)

142

Serious AEs

1.4%

Results posted

Nov 2016

Primary outcome: Primary: Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity — 8.3; 8.1 units on a scale — p=0.7

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: cognitive behavioral therapy (Behavioral); desipramine hydrochloride (Drug); benztropine mesylate 0.125 mg daily (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Dec 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity	8.0; 8.4	0.6
SECONDARY Roland and Morris Disability Questionnaire	8.7; 8.9	0.8

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.

Eligibility Criteria

Inclusion Criteria

Chronic back pain (daily pain for > 6 months)

Exclusion Criteria

Major medical conditions which might contraindicate antidepressant treatment

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00964886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.