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临床试验/NCT00763178
NCT00763178已完成早期 1 期

Effects of Duloxetine on Fear Conditioning in PTSD

Yale University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2007年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
26
试验地点
1
主要终点
Anxiolytic and antidepressant effects of duloxetine in patients with chronic PTSD

研究概览

简要总结

Chronic posttraumatic stress disorder (PTSD) is a debilitating disorder and treatment response to pharmacological interventions has been modest for these patients. Chronic elevated anxiety and associated psychophysiological parameters including increased heart rate and alterations in skin conductance are key symptoms of chronic PTSD. Selective serotonin reuptake inhibitors (SRIs) are considered treatment of first choice for these patients, however a substantial portion of patients treated with SRIs do not respond sufficiently. Therefore, there is a need to establish novel and effective treatment strategies for these patients. Recently, duloxetine has received considerable attention since it was shown in multiple controlled trials to be an effective treatment for people with major depressive disorder (MDD), a condition which is often co-morbid with PTSD. In chronic PTSD, the psychophysiological responses at baseline and in response to treatment with duloxetine have been inadequately studied and may provide novel insight into antidepressant and anxiolytic mechanisms of this compound.

Primary Aim 1: Evaluate the anxiolytic and antidepressant effects of duloxetine in patients with chronic PTSD.

Secondary Aim 2: Evaluate the effects of duloxetine on fear conditioned psychophysiological responses (including startle eyeblink, skin conductance, and cardiovascular inter-beat interval) at baseline and after 8 weeks of naturalistic treatment in chronic PTSD patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

PTSD

Experimental

Duloxetine

干预措施: Duloxetine (Drug)

结局指标

主要结局

Anxiolytic and antidepressant effects of duloxetine in patients with chronic PTSD

时间窗: 8 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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