Effect of Antidepressants on Back Pain - Tabular View

Tracking Information

First Received Date ^ICMJE

July 3, 2001

Last Updated Date

September 17, 2009

Start Date ^ICMJE

April 1999

Primary Completion Date

December 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Descriptor Differential Scale Pain Intensity [ Time Frame: 12 weeks post baseline ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00018200 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Effect of Antidepressants on Back Pain

Official Title ^ICMJE

Efficacy of Antidepressants in Chronic Back Pain

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 noradrenoline 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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Back Pain
Sciatica

Intervention ^ICMJE

Drug: Desipramine
Drug: Fluoxetine
Drug: Benztropine

Study Arms / Comparison Groups

Experimental: Desipramine, low, middle or high exposure
Experimental: Fluoxetine, low, middle, or high exposure
Placebo Comparator: Benztropine .125-.5mg daily

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

130

Completion Date

March 2004

Primary Completion Date

December 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Chronic back pain (pain on a daily basis for six months or longer)
Age 18-65
No major medical illness

Exclusion Criteria:

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00018200

Responsible Party

Atkinson, Joseph - Principal Investigator, Department of Veterans Affairs

Study ID Numbers ^ICMJE

ADRD-018-98F

Study Sponsor ^ICMJE

Department of Veterans Affairs

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Joseph H. Atkinson, MD

VA San Diego Healthcare System, San Diego

Information Provided By

Department of Veterans Affairs

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP