Effect of Antidepressants on Back Pain

NCT ID: NCT00018200

Last Updated: 2012-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-04-30

Study Completion Date

2004-03-31

Brief Summary

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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

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Conditions

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Back Pain Sciatica

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1

Desipramine, low, middle or high exposure

Group Type EXPERIMENTAL

Desipramine

Intervention Type DRUG

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

Arm 2

Fluoxetine, low, middle, or high exposure

Group Type EXPERIMENTAL

Fluoxetine

Intervention Type DRUG

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

Arm 3

Benztropine .125-.5mg daily

Group Type PLACEBO_COMPARATOR

Benztropine

Intervention Type DRUG

Daily dose 0.125 to 0.5mg

Interventions

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Desipramine

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

Intervention Type DRUG

Fluoxetine

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

Intervention Type DRUG

Benztropine

Daily dose 0.125 to 0.5mg

Intervention Type DRUG

Other Intervention Names

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Anafranil Prozac Cogentin

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph H. Atkinson, MD

Role: PRINCIPAL_INVESTIGATOR

VA San Diego Healthcare System, San Diego

Locations

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VA San Diego Healthcare System, San Diego

San Diego, California, United States

Site Status

Countries

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United States

References

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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 Apr;27(2):135-42. doi: 10.1097/jcp.0b013e3180333ed5.

Reference Type RESULT
PMID: 17414235 (View on PubMed)

Other Identifiers

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ADRD-018-98F

Identifier Type: -

Identifier Source: org_study_id

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