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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. Identifier: NCT00018200
Recruitment Status : Completed
First Posted : July 5, 2001
Last Update Posted : June 5, 2012
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

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

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Study Type : Interventional  (Clinical Trial)
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 : April 1999
Actual Primary Completion Date : December 2003
Actual Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

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 Name: 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 Name: Prozac

Placebo Comparator: Arm 3
Benztropine .125-.5mg daily
Drug: Benztropine
Daily dose 0.125 to 0.5mg
Other Name: Cogentin

Primary Outcome Measures :
  1. Descriptor Differential Scale Pain Intensity [ Time Frame: 12 weeks post baseline ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00018200

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United States, California
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
Sponsors and Collaborators
US Department of Veterans Affairs
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Principal Investigator: Joseph H. Atkinson, MD VA San Diego Healthcare System, San Diego

Publications of Results:
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Responsible Party: US Department of Veterans Affairs Identifier: NCT00018200    
Other Study ID Numbers: ADRD-018-98F
First Posted: July 5, 2001    Key Record Dates
Last Update Posted: June 5, 2012
Last Verified: June 2012
Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):
Back pain
Additional relevant MeSH terms:
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Back Pain
Neurologic Manifestations
Signs and Symptoms
Sciatic Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Antidepressive Agents, Tricyclic
Adrenergic Uptake Inhibitors
Adrenergic Agents