Effect of Antidepressants on Back Pain

This study has been completed.
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
First received: July 3, 2001
Last updated: June 4, 2012
Last verified: June 2012
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
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 VA Office of Research and Development:

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


Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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
  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

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
Principal Investigator: Joseph H. Atkinson, MD VA San Diego Healthcare System, San Diego
  More Information

Responsible Party: VA Office of Research and Development
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 VA Office of Research and Development:
Back pain

Additional relevant MeSH terms:
Back Pain
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Peripheral Nervous System Diseases
Sciatic Neuropathy
Signs and Symptoms
Antidepressive Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors
Anti-Dyskinesia Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents, Tricyclic
Antiparkinson Agents
Autonomic Agents
Cholinergic Agents
Cholinergic Antagonists
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Dopamine Agents
Dopamine Uptake Inhibitors
Enzyme Inhibitors
Membrane Transport Modulators

ClinicalTrials.gov processed this record on May 26, 2016