Efficacy of Antidepressants in Chronic Back Pain - Full Text View

Sponsor:	Department of Veterans Affairs
Collaborator:	University of California, San Diego
Information provided by (Responsible Party):	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00964886

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 II

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:

MedlinePlus related topics: Antidepressants Back Pain

Drug Information available for: Desipramine Desipramine hydrochloride Clomipramine hydrochloride Benztropine Benzatropine methanesulfonate Clomipramine

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

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 2014
Estimated Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 desipramine hydrochloride	Drug: desipramine hydrochloride desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml Other Name: Anafranil
Experimental: 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: 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: 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00964886

Contacts

Contact: Shetal Patel, PhD	(858) 642-3830	backpainresearch@vapop.ucsd.edu
Contact: Judy Ortega, BA	(858) 642-3830	judith.ortega@va.gov

Locations

United States, California
VA San Diego Healthcare System, San Diego	Recruiting
San Diego, California, United States, 92161
Contact: Janet M Peyton, MA MA 858-642-3657 janet.peyton@va.gov
Contact: Gerhard Schulteis, PhD (858) 642-3657 gerhard.schulteis@va.gov
Principal Investigator: Joseph H. Atkinson, MD

Sponsors and Collaborators

Department of Veterans Affairs

University of California, San Diego

Investigators

Principal Investigator:

Joseph H. Atkinson, MD

VA San Diego Healthcare System, San Diego

More Information

No publications provided

Responsible Party:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00964886 History of Changes
Other Study ID Numbers:	NURA-019-09S
Study First Received:	August 24, 2009
Last Updated:	November 17, 2011
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

chronic pain
back pain
antidepressants

Additional relevant MeSH terms:

Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Clomipramine
Desipramine
Antidepressive Agents
Benztropine
Antidepressive Agents, Tricyclic
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
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on February 09, 2012