NCT00018200

Effect of Antidepressants on Back Pain

Efficacy of Antidepressants in Chronic Back Pain

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: US Department of Veterans Affairs · Federal
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Back Pain
• Sciatica

Interventions

Type	Name	Description
DRUG	Desipramine	Low exposure (40-70 ng/mL), Middle exposure (70-130 ng/mL), High exposure (130-200 ng/mL)
DRUG	Fluoxetine	Low exposure (200-399 ng/mL), Middle exposure (400-499 ng/mL), High exposure (500-700ng/mL)
DRUG	Benztropine	Daily dose 0.125 to 0.5mg

Timeline

• Start date: 1999-04-01
• Primary completion: 2003-12-01
• Completion: 2004-03-01
• First posted: 2001-07-05
• Last updated: 2012-06-05

Locations

1 site across 1 country: United States