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Efficacy of Antidepressants in Chronic Back Pain

NCT00964886 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2016-11-29

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

cognitive behavioral therapy

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

DRUG

desipramine hydrochloride

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

BEHAVIORAL

cognitive behavioral therapy

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

DRUG

benztropine mesylate 0.125 mg daily

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

DRUG

desipramine hydrochloride

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

Sponsors & Collaborators

Principal Investigators

  • Joseph H Atkinson, MD · VA San Diego Healthcare System, San Diego, CA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2014-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00964886 on ClinicalTrials.gov