This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Study Hypothesis:In subjects who continue to have activity-limiting osteoarthritis pain after treatment with acetaminophen or non-steroidal anti-inflammatory agents, 150-225 mg Venlafaxine per day will provide significant additional pain relief (> 30%).Study Design: This will be a single-blind, placebo washout trial. This is more rigorous than an open label design, but easier to accomplish than a randomized placebo-controlled trial. It is appropriate because there are no trials (randomized or open) of antidepressants for OA pain. Subjects will be informed that they may receive placebo during the course of the trial, but they will not know that all subjects will receive placebo for the first 2 weeks of the trial. Following 2 weeks of placebo, non-responders will be advanced over a 4-6 week period to 150 or 225 mg of venlafaxine per day as tolerated. They will be maintained on this dose for 6 weeks. Primary outcome assessment will occur after 12 weeks of venlafaxine treatment. Anticipated Findings: We anticipate a >30% pre-treatment to post-treatment difference in average pain intensity independent of initial depression severity. Depressive symptoms will also improve but pain effects will be demonstrated to be independent by path analysis.
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