Effect of Antidepressants on Back Pain

US Department of Veterans Affairs (VA)

Status and phase: Completed; Phase 2

Conditions: Back Pain; Sciatica

Treatments: Drug: Benztropine; Drug: Fluoxetine; Drug: Desipramine

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00018200

ADRD-018-98F

Details and patient eligibility

About

The purpose of this study is to determine whether different types of antidepressant medicines relieve back pain that has lasted at least six months on a daily basis. Study participants will be assigned to treatment with either a antidepressant acting on the serotonin system in the brain (fluoxetine), one acting on the noradrenaline system (desipramine, or to a control medication not expected to relieve pain (benztropine). Each participant will be seen at least nine times during their 12 weeks on medication. This is a phase 2/3, outpatient study.

Enrollment: 130 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic back pain (pain on a daily basis for six months or longer)
• Age 18-65
• No major medical illness

Exclusion criteria

• medical contraindication to tricyclic antidepressants
• recent alcohol or substance use disorder
• bipolar disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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130 participants in 3 patient groups, including a placebo group

Arm 1

Experimental group

Description:

Desipramine, low, middle or high exposure

Treatment:

Drug: Desipramine

Arm 2

Experimental group

Description:

Fluoxetine, low, middle, or high exposure

Treatment:

Drug: Fluoxetine

Arm 3

Placebo Comparator group

Description:

Benztropine .125-.5mg daily

Treatment:

Drug: Benztropine