Effect of Antidepressants on Back Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00018200
First received: July 3, 2001
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Back Pain
Sciatica
Drug: Desipramine
Drug: Fluoxetine
Drug: Benztropine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Antidepressants in Chronic Back Pain

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

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

Enrollment: 130
Study Start Date: April 1999
Study Completion Date: March 2004
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00018200

Locations
United States, California
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
Sponsors and Collaborators
Investigators
Principal Investigator: Joseph H. Atkinson, MD VA San Diego Healthcare System, San Diego
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00018200     History of Changes
Other Study ID Numbers: ADRD-018-98F
Study First Received: July 3, 2001
Last Updated: June 4, 2012
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
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
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents, Tricyclic
Enzyme Inhibitors
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on September 18, 2014