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Effect of Antidepressants on Back Pain

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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

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

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
Primary Completion Date : December 2003
Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT00018200


Locations
United States, California
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Joseph H. Atkinson, MD VA San Diego Healthcare System, San Diego

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00018200     History of Changes
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:
analgesia
Back pain
sciatica

Additional relevant MeSH terms:
Back Pain
Sciatica
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neuralgia
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Antidepressive Agents
Fluoxetine
Desipramine
Benztropine
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