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Effect of Antidepressants on Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00018200
Recruitment Status : Completed
First Posted : July 5, 2001
Last Update Posted : June 5, 2012
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Tracking Information
First Submitted Date  ICMJE July 3, 2001
First Posted Date  ICMJE July 5, 2001
Last Update Posted Date June 5, 2012
Study Start Date  ICMJE April 1999
Actual Primary Completion Date December 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2009)
Descriptor Differential Scale Pain Intensity [ Time Frame: 12 weeks post baseline ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Back Pain
  • Sciatica
Intervention  ICMJE
  • Drug: Desipramine
    Low exposure (40-70 ng/mL), Middle exposure (70-130 ng/mL), High exposure (130-200 ng/mL)
    Other Name: Anafranil
  • Drug: Fluoxetine
    Low exposure (200-399 ng/mL), Middle exposure (400-499 ng/mL), High exposure (500-700ng/mL)
    Other Name: Prozac
  • Drug: Benztropine
    Daily dose 0.125 to 0.5mg
    Other Name: Cogentin
Study Arms  ICMJE
  • Experimental: Arm 1
    Desipramine, low, middle or high exposure
    Intervention: Drug: Desipramine
  • Experimental: Arm 2
    Fluoxetine, low, middle, or high exposure
    Intervention: Drug: Fluoxetine
  • Placebo Comparator: Arm 3
    Benztropine .125-.5mg daily
    Intervention: Drug: Benztropine
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2009)
130
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2004
Actual 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:

  • medical contraindication to tricyclic antidepressants
  • recent alcohol or substance use disorder
  • bipolar disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00018200
Other Study ID Numbers  ICMJE ADRD-018-98F
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party VA Office of Research and Development ( US Department of Veterans Affairs )
Study Sponsor  ICMJE US Department of Veterans Affairs
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joseph H. Atkinson, MD VA San Diego Healthcare System, San Diego
PRS Account VA Office of Research and Development
Verification Date June 2012

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