VENLAFAXINE TREATMENT FOR ACTIVITY-LIMITING OSTEOARTHRITIS PAIN

文拉法辛治疗限制活动的骨关节炎疼痛

• 批准号: 7603498
• 负责人: MARK A SULLIVAN
• 金额: $ 0.11万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603498
• 关键词: Acetaminophen; Aftercare; Antidepressive Agents; Computer Retrieval of Information on Scientific Projects Database; Degenerative polyarthritis; Dose; Funding; Grant; Institution; Label; Mental Depression; Non-Steroidal Anti-Inflammatory Agents; Outcome Assessment; Pain; Placebos; Randomized Controlled Clinical Trials; Research; Research Design; Research Personnel; Resources; Severities; Source; United States National Institutes of Health; Week; day; depressive symptoms; design; improved; randomized placebo controlled trial; venlafaxine; week trial

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for 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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 中心，不一定是研究者的机构。 研究假设： 对于在使用对乙酰氨基酚或非甾体抗炎药治疗后继续出现限制活动的骨关节炎疼痛的受试者，每天 150-225 mg 文拉法辛将提供显着的额外疼痛缓解（> 30%）。 研究设计： 这将是一项单盲、安慰剂清除试验。这比开放标签设计更严格，但比随机安慰剂对照试验更容易完成。这是合适的，因为还没有抗抑郁药治疗骨关节炎疼痛的试验（随机或开放）。 受试者将被告知他们在试验过程中可能会接受安慰剂，但他们不会知道所有受试者将在试验的前两周接受安慰剂。服用安慰剂 2 周后，无反应者将在 4-6 周内将文拉法辛剂量提升至每天 150 或 225 毫克（只要耐受）。他们将维持该剂量 6 周。主要结局评估将在文拉法辛治疗 12 周后进行。 预期结果： 我们预计治疗前与治疗后的平均疼痛强度差异将大于 30%，与初始抑郁严重程度无关。抑郁症状也会改善，但路径分析将证明疼痛影响是独立的。