Effect of Antidepressants on Back Pain

Back Pain Clinical Trial

Official title:

Efficacy of Antidepressants in Chronic Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00018200
• Other study ID #: ADRD-018-98F
• Status: Completed
• Phase: Phase 2
• First received: July 3, 2001
• Last updated: June 4, 2012
• Start date: April 1999
• Est. completion date: March 2004

Study information

• Verified date: June 2012
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: March 2004
• Est. primary completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Sciatica

Intervention

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

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Atkinson JH, Slater MA, Capparelli EV, Wallace MS, Zisook S, Abramson I, Matthews SC, Garfin SR. Efficacy of noradrenergic and serotonergic antidepressants in chronic back pain: a preliminary concentration-controlled trial. J Clin Psychopharmacol. 2007 Ap — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Descriptor Differential Scale Pain Intensity		12 weeks post baseline	No