MAINTENANCE FLUOXETINE IN POSTTRAUMATIC STRESS DISORDER

维持氟西汀治疗创伤后应激障碍

• 批准号: 2403855
• 负责人: JONATHAN R DAVIDSON
• 金额: $ 19.86万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-08-01 至 2002-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2403855
• 关键词: clinical research; clinical trials; drug adverse effect; fluoxetine; human subject; human therapy evaluation; interview; longitudinal human study; mental disorder chemotherapy; placebos; posttraumatic stress disorder; psychological tests; psychopharmacology; relapse /recurrence; therapy compliance; clinical research; clinical trials; drug adverse effect; fluoxetine; human subject; human therapy evaluation; interview; longitudinal human study; mental disorder chemotherapy; placebos; posttraumatic stress disorder; psychological tests; psychopharmacology; relapse /recurrence; therapy compliance

PTSD is a chronic and distressing disorder, affecting up to 8% of the U.S. population. It is associated with significant morbidity, possible increased mortality and may persist for many years. Controlled studies have shown efficacy for antidepressant drugs in PTSD. Specifically, fluoxetine has been the most studied. No trials have evaluated the effects of long-term pharmacotherapy in PTSD, nor have they looked at the issues of relapse upon discontinuation. Little is known as to the optimum length of pharmacotherapy, or even whether long-term therapy is necessary. In this proposal we aim to assess relapse and recurrence rates of PTSD in 74 patients with PTSD who have responded successfully to 6 months of open-label treatment with fluoxetine (FLU). 126 subjects will enter open-label treatment with fluoxetine (FLU) for 6 months. At 6 months, 82 subjects will be randomized to either continue of FLU or receive placebo (PBO) double-blind for a period of up to 6 months, at which time FLU responders will agin be randomized to continue to FLU or receive PBO for a further 3 months, thus providing a total term of 15 months treatment up to a maximum of 74 patients. The goals of the study are to compare rates of relapse/recurrence in the FLU and PBO groups after each of the discontinuation points. Subjects will initially be diagnosed by the SCID, with symptom severity measures including the CGI, structured interview (SI), Hamilton Scales and self-rating measures for PTSD, to include the Davidson Trauma Scale, Impact of Events Scale Revised and Patient Global Improvement. Adverse effects of the medication will also be monitored and compliance checked with pill counts, daily logs and medication levels. This study will provide information about whether there is extended benefit by continuing pharmacotherapy for more than 6 months, whether long-term pharmacotherapy reduces the likelihood of symptom return during 12 months of pharmacotherapy. Health services and cost implications of such findings remain considerable, given the morbidity associated with PTSD.

PTSD是一种慢性和令人痛苦的疾病，影响多达8％ 美国人口。 它与明显的发病率有关 死亡率增加，可能会持续多年。 受控 研究表明，PTSD中抗抑郁药的功效。 具体而言，氟西汀的研究最多。 没有试验 评估了长期药物疗法对PTSD的影响，也没有 他们是否看过中断时复发的问题。 小的 被称为最佳药物疗法的最佳长度，甚至 长期治疗是否需要。在这个建议中，我们的目标是 评估74例患者的PTSD复发和复发率 已成功响应6个月的开放标签的PTSD 用氟西汀（流感）治疗。 126个受试者将进入开放标签 用氟西汀（流感）处理6个月。 6个月，82 受试者将被随机分配为继续流感或接受 安慰剂（PBO）双盲持续时间长达6个月，在此期间 时间流感反应者将被随机分配以继续流感或 再接收PBO 3个月，因此总学期为15 几个月治疗最多可达74例患者。 目标的目标 研究要比较流感和PBO的复发/复发率 每个中断点之后的小组。 受试者最初会 通过SCID诊断，并采取症状严重程度措施 包括CGI，结构化访谈（SI），汉密尔顿秤和 PTSD的自我评价措施，包括戴维森创伤 比例，事件规模修订的影响和患者全球 改进。 药物的不良影响也将是 通过药丸计数，每日原木和合规性检查和合规性检查 用药水平。 这项研究将提供有关是否的信息 通过继续药物疗法，可以扩大好处 超过6个月，长期药物疗法是否会减少 在药物治疗12个月内症状的可能性。 保健服务和此类发现的成本影响仍然存在 鉴于与PTSD相关的发病率相当大。