Efficacy of Antidepressants in Chronic Back Pain

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00964886
First received: August 24, 2009
Last updated: July 16, 2015
Last verified: July 2015
  Purpose
This 12 week placebo controlled clinical trial tests the individual and combined effects of an antidepressant medication and cognitive behavioral therapy for chronic back pain.

Condition Intervention Phase
Back Pain
Behavioral: cognitive behavioral therapy
Drug: desipramine hydrochloride
Drug: benztropine mesylate 0.125 mg daily
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 of pain intensity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Roland and Morris Disability [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2010
Estimated Study Completion Date: December 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
desipramine hydrochloride
Drug: desipramine hydrochloride
desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
Other Name: Anafranil
Experimental: Arm 2
cognitive behavioral therapy
Behavioral: cognitive behavioral therapy
cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life
Experimental: Arm 3
desipramine hydrochloride and cognitive behavioral therapy
Drug: desipramine hydrochloride
desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml
Other Name: Anafranil
Behavioral: cognitive behavioral therapy
cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life
Placebo Comparator: Arm 4
anticholinergic medication; active placebo
Drug: benztropine mesylate 0.125 mg daily
benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride
Other Name: Cogentin

Detailed Description:
This is a 4 arm 12 week randomized clinical trial comparing the efficacy of 1) low concentration desipramine (< 60 ng/ml); 2) cognitive behavioral therapy; 3) low concentration desipramine + cognitive behavioral therapy; and 4) placebo medication.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic back pain (daily pain for > 6 months)

Exclusion Criteria:

  • Major medical conditions which might contraindicate antidepressant treatment
  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: NCT00964886

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

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00964886     History of Changes
Other Study ID Numbers: NURA-019-09S 
Study First Received: August 24, 2009
Last Updated: July 16, 2015
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
chronic pain
back pain
antidepressants

Additional relevant MeSH terms:
Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Antidepressive Agents
Benztropine
Desipramine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Anti-Dyskinesia Agents
Antidepressive Agents, Tricyclic
Antiparkinson Agents
Autonomic Agents
Cholinergic Agents
Cholinergic Antagonists
Dopamine Agents
Dopamine Uptake Inhibitors
Enzyme Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 26, 2016