OCD TREATMENT OUTCOMES--BEYOND PHASE 3 DRUG TRIALS

强迫症治疗结果——超越第三阶段药物试验

• 批准号: 6185361
• 负责人: DEBORAH ACKERMAN
• 金额: $ 7.61万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-08-01 至 2003-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6185361
• 关键词: clinical research; clomipramine; fluoxetine; human data; human therapy evaluation; longitudinal human study; mental disorder chemotherapy; mental health epidemiology; obsessive compulsive disorder; outcomes research; remission /regression; sign /symptom; statistics /biometry

The research career award would provide Dr. Ackerman with didactic and research training to conduct epidemiologic studies of treatment outcomes and clinical trials, including methods of psychiatric screening and psychological assessment, diagnostic procedures, and advanced statistical techniques. Her previous research has focused on the identification of predictors of response to psychotherapeutics by performing secondary analyses of data collected by pharmaceutical companies in randomized clinical trials (RCTs). During the first 3 years of this grant, formal course work and directed study will train Dr. Ackerman in the biological and methodological principles of clinical psychopharmacology and pharmacoepidemiology. An observational study during the fourth and fifth years will evaluate treatment response in obsessive-compulsive disorder (OCD) and extend the findings from industry-sponsored clinical trials to clinic settings. A cohort will be drawn by retrospective chart review of all patients with OCD treated in the UCLA Neuropsychiatric Hospital Mood and Anxiety Disorders Program during the previous 4 years. Two types of cohorts will be chosen. One will include all patients and will assess short and long-term outcomes of all treatments. The other will be restricted to patients who received either clomipramine or fluoxetine and will be subject to the same exclusion criteria and follow-up periods that were employed in the Phase 3 RCTs sponsored by the two drugs' developers. Results from the two cohorts will be compared with respect to predictors of all possible outcomes, including response, partial response, added medications, drop- outs. Predictors of response from the cohorts will then be compared with predictors of response that were identified by analyzing data from two Phase 3 trials of clomipramine and fluoxetine. Statistical methods will be used that can identify and resolve problems of biological heterogeneity, i.e., when people vary in their response to a particular treatment and in their risk for a given condition, and multiple- comparison artifacts that are frequently encountered in analyzing data from multicenter studies.

研究职业奖将为Ackerman博士提供教学和 研究治疗结果流行病学研究的研究培训 和临床试验，包括精神筛查和 心理评估，诊断程序和高级 统计技术。 她以前的研究重点是 通过 对药物收集的数据进行次要分析 随机临床试验（RCT）的公司。 在第3个 这项赠款的年，正式的课程工作和定向学习将培训 Ackerman博士的临床生物学和方法论原理 心理药理学和药物epidemiology。 观察性研究 在第四和第五年，将评估治疗反应 强迫症（OCD）并从 行业赞助的临床试验到诊所环境。 队列遗嘱 通过对所有经过OCD治疗的患者的回顾性图表审查来绘制 在UCLA神经精神病医院的情绪和焦虑症计划中 在过去的四年中。 将选择两种类型的队列。 一 将包括所有患者，并将评估短期和长期结局 所有治疗方法。 另一个将仅限于 接受了氯米帕明或氟西汀，将受到 相同的排除标准和随访期 这两种药物开发人员赞助的第3阶段RCT。 结果 在所有可能的预测因子方面将进行两个队列的比较 结果，包括反应，部分反应，增加了药物，滴剂 - 出口。然后将比较来自队列的反应的预测指标 通过分析两个数据来识别的响应预测指标 氯米帕明和氟西汀的3阶段试验。统计方法将 可以使用可以识别和解决生物学问题的问题 异质性，即当人们对特定的回应变化时 治疗及其患有给定状况的风险，多重 分析数据时经常遇到的比较伪像 来自多中心研究。