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| Sponsor: | Department of Veterans Affairs |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00018200 |
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 noradrenoline 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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Efficacy of Antidepressants in Chronic Back Pain |
| 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 |
|---|---|
|
1: Experimental
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)
|
|
2: Experimental
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)
|
|
3: Placebo Comparator
Benztropine .125-.5mg daily
|
Drug: Benztropine
Daily dose 0.125 to 0.5mg
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| VA San Diego Healthcare System, San Diego | |
| San Diego, California, United States, 92161 | |
| Principal Investigator: | Joseph H. Atkinson, MD | VA San Diego Healthcare System, San Diego |
More Information
| Responsible Party: | Department of Veterans Affairs ( Atkinson, Joseph - Principal Investigator ) |
| Study ID Numbers: | ADRD-018-98F |
| Study First Received: | July 3, 2001 |
| Last Updated: | September 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00018200 History of Changes |
| Health Authority: | United States: Federal Government |
|
analgesia Back pain sciatica |
|
Dopamine Uptake Inhibitors Sciatic Neuropathy Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Adrenergic Uptake Inhibitors Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Pain Cholinergic Agents |
Desipramine Mononeuropathies Sciatica Signs and Symptoms Neuromuscular Diseases Therapeutic Uses Antidepressive Agents, Second-Generation Antidepressive Agents Neuralgia Nervous System Diseases Enzyme Inhibitors Serotonin Uptake Inhibitors Back Pain Pharmacologic Actions Antidepressive Agents, Tricyclic |
