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Effect of Antidepressants on Back Pain

Primary Purpose

Back Pain, Sciatica

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Desipramine
Fluoxetine
Benztropine
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain focused on measuring analgesia, Back pain, sciatica

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • VA San Diego Healthcare System, San Diego

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Desipramine, low, middle or high exposure

Fluoxetine, low, middle, or high exposure

Benztropine .125-.5mg daily

Outcomes

Primary Outcome Measures

Descriptor Differential Scale Pain Intensity

Secondary Outcome Measures

Full Information

First Posted
July 3, 2001
Last Updated
June 4, 2012
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00018200
Brief Title
Effect of Antidepressants on Back Pain
Official Title
Efficacy of Antidepressants in Chronic Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
April 1999 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
March 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Sciatica
Keywords
analgesia, Back pain, sciatica

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Desipramine, low, middle or high exposure
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Fluoxetine, low, middle, or high exposure
Arm Title
Arm 3
Arm Type
Placebo Comparator
Arm Description
Benztropine .125-.5mg daily
Intervention Type
Drug
Intervention Name(s)
Desipramine
Other Intervention Name(s)
Anafranil
Intervention Description
Low exposure (40-70 ng/mL), Middle exposure (70-130 ng/mL), High exposure (130-200 ng/mL)
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Other Intervention Name(s)
Prozac
Intervention Description
Low exposure (200-399 ng/mL), Middle exposure (400-499 ng/mL), High exposure (500-700ng/mL)
Intervention Type
Drug
Intervention Name(s)
Benztropine
Other Intervention Name(s)
Cogentin
Intervention Description
Daily dose 0.125 to 0.5mg
Primary Outcome Measure Information:
Title
Descriptor Differential Scale Pain Intensity
Time Frame
12 weeks post baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph H. Atkinson, MD
Organizational Affiliation
VA San Diego Healthcare System, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17414235
Citation
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.
Results Reference
result

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Effect of Antidepressants on Back Pain

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