Efficacy of Antidepressants in Chronic Back Pain
This study is currently recruiting participants.
Verified March 2013 by Department of Veterans Affairs
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00964886
First received: August 24, 2009
Last updated: March 21, 2013
Last verified: March 2013
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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:
Drug Information available for:
Desipramine
Desipramine hydrochloride
Benztropine
Benztropine mesylate
Clomipramine
Clomipramine hydrochloride
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: 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
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
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: | March 21, 2013 |
| 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 May 21, 2013