Efficacy of Antidepressants in Chronic Back Pain

VA Office of Research and Development

Status and phase: Completed; Phase 2

Conditions: Back Pain

Treatments: Drug: desipramine hydrochloride; Behavioral: cognitive behavioral therapy; Drug: benztropine mesylate 0.125 mg daily

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00964886

NURA-019-09S

Details and patient eligibility

About

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.

Full 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).

Enrollment: 142 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Major medical conditions which might contraindicate antidepressant treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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142 participants in 4 patient groups, including a placebo group

Arm 1

Experimental group

Description:

desipramine hydrochloride

Treatment:

Drug: desipramine hydrochloride

Drug: desipramine hydrochloride

Arm 2

Experimental group

Description:

cognitive behavioral therapy

Treatment:

Behavioral: cognitive behavioral therapy

Behavioral: cognitive behavioral therapy

Arm 3

Experimental group

Description:

desipramine hydrochloride and cognitive behavioral therapy

Treatment:

Drug: desipramine hydrochloride

Behavioral: cognitive behavioral therapy

Behavioral: cognitive behavioral therapy

Drug: desipramine hydrochloride

Arm 4

Placebo Comparator group

Description:

anticholinergic medication; active placebo

Treatment:

Drug: benztropine mesylate 0.125 mg daily