Effect of Antidepressants on Back Pain

Sponsor

US Department of Veterans Affairs (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00018200

Collaborator

(none)

130

Enrollment

Location

Arms

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Back Pain Sciatica	Drug: Desipramine Drug: Fluoxetine Drug: Benztropine	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy of Antidepressants in Chronic Back Pain

Study Start Date :

Apr 1, 1999

Actual Primary Completion Date :

Dec 1, 2003

Actual Study Completion Date :

Mar 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Desipramine, low, middle or high exposure	Drug: Desipramine Low exposure (40-70 ng/mL), Middle exposure (70-130 ng/mL), High exposure (130-200 ng/mL) Other Names: Anafranil
Experimental: Arm 2 Fluoxetine, low, middle, or high exposure	Drug: Fluoxetine Low exposure (200-399 ng/mL), Middle exposure (400-499 ng/mL), High exposure (500-700ng/mL) Other Names: Prozac
Placebo Comparator: Arm 3 Benztropine .125-.5mg daily	Drug: Benztropine Daily dose 0.125 to 0.5mg Other Names: Cogentin

Arm

Intervention/Treatment

Experimental: Arm 1

Desipramine, low, middle or high exposure

Drug: Desipramine

Low exposure (40-70 ng/mL), Middle exposure (70-130 ng/mL), High exposure (130-200 ng/mL)

Other Names:

Anafranil

Experimental: Arm 2

Fluoxetine, low, middle, or high exposure

Drug: Fluoxetine

Low exposure (200-399 ng/mL), Middle exposure (400-499 ng/mL), High exposure (500-700ng/mL)

Other Names:

Prozac

Placebo Comparator: Arm 3

Benztropine .125-.5mg daily

Drug: Benztropine

Daily dose 0.125 to 0.5mg

Other Names:

Cogentin

Outcome Measures

Primary Outcome Measures

Descriptor Differential Scale Pain Intensity [12 weeks post baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA San Diego Healthcare System, San Diego	San Diego	California	United States	92161

Sponsors and Collaborators

US Department of Veterans Affairs

Investigators

Principal Investigator: Joseph H. Atkinson, MD, VA San Diego Healthcare System, San Diego

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

US Department of Veterans Affairs

ClinicalTrials.gov Identifier:

NCT00018200

Other Study ID Numbers:

ADRD-018-98F

First Posted:

Jul 5, 2001

Last Update Posted:

Jun 5, 2012

Last Verified:

Jun 1, 2012

Keywords provided by US Department of Veterans Affairs

analgesia

Back pain

sciatica

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 5, 2012