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Clinical Trial Name - Effect of Antidepressants on Back Pain
| Original Study ID : ADRD-018-98F |
| NCT ID : NCT00018200 |
| Brief Title : Effect of Antidepressants on Back Pain |
| Official Title : Efficacy of Antidepressants in Chronic Back Pain |
| Brief Summary : 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. |
| Source : Department of Veterans Affairs |
| Overall Status : Completed |
| Start Date : April 1999 |
| End Date : March 2004 |
| Completion Date : March 2004 |
| Official Title : Phase 2 |
| Phase : Interventional |
| Study Design : Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Enrollment : 130 |
| Verification Date : March 2009 |
| First Received Date : July 3, 2001 |
| Trial Eligibility |
| Criteria : Inclusion Criteria: - Chronic back pain (pain on a daily basis for six months or longer) - Age 18-65 - No major medical illness Exclusion Criteria: |
| Gender : Both |
| Minimum Age : 18 Years |
| Maximum Age : 65 Years |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : VA San Diego Healthcare System, San Diego |
| City : San Diego |
| State : California |
| Zip Code : 92161 |
| Country : United States |
| OutComes |
| Primary OutComes |
| Measure : Descriptor Differential Scale Pain Intensity |
| Time Frame : 12 weeks post baseline |
| Safety issue : No |
| Interventions |
| Type : Drug |
| Name : Desipramine |
| Description : Low exposure (40-70 ng/mL), Middle exposure (70-130 ng/mL), High exposure (130-200 ng/mL) |
| Type : Drug |
| Name : Fluoxetine |
| Description : Low exposure (200-399 ng/mL), Middle exposure (400-499 ng/mL), High exposure (500-700ng/mL) |
| Type : Drug |
| Name : Benztropine |
| Description : Daily dose 0.125 to 0.5mg |
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