Effect of Antidepressants on Back Pain

Phase 2

Completed

• Conditions: Back Pain; Sciatica
• Interventions: Drug: Benztropine; Drug: Fluoxetine; Drug: Desipramine

• Registration Number: NCT00018200
• Lead Sponsor: US Department of Veterans Affairs

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-04
• Study First Submitted: 2001-07-03
• Study First Submitted QC: 2001-07-04
• Study First Posted: 2001-07-05
• Primary Completion: 2003-12
• Study Completion: 2004-03
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-04
• Last Update Posted: 2012-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3	Benztropine	Benztropine .125-.5mg daily
Arm 2	Fluoxetine	Fluoxetine, low, middle, or high exposure
Arm 1	Desipramine	Desipramine, low, middle or high exposure

Primary Outcome Measures

Name	Time	Method
Descriptor Differential Scale Pain Intensity	12 weeks post baseline

Trial Locations

Locations (1)

VA San Diego Healthcare System, San Diego; 🇺🇸 San Diego, California, United States