Pharmacologic Influence of Escitalopram on the Reduction of Fear Acquisition and Triggered Renewal During Fear Conditioning: a Model for the Prevention and Persistence of Learned Fear and Anxiety in Response to Trauma and Stress
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 65
- 主要终点
- Physiological Reactivity as Measured by Square-root Transformed Skin Conductance Conditioned Response in Early Extinction Trials 1 to 4
研究概览
简要总结
The purpose of the study is to learn how differences in learning under mildly-stressful circumstances may be changed by taking an antidepressant medication. This medication is called Lexapro (Escitalopram). The investigators will also examine the impact of any anxiety, depression, and stress related symptoms on learning processes. The investigators will also look at the response of these symptoms to Lexapro.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female outpatients 18 to 75 years of age
- •Must have no current DSM-IV Axis I diagnosis as measured by the SCID (Structured Clinical Interview for DSM-IV-TR axis 1 disorders) with a trained study investigator. Past history of anxiety disorders, major depressive episodes or substance abuse disorders at least six months prior to baseline are not exclusionary.
排除标准
- •Patients will be excluded from entry into the study for current serious medical conditions or other conditions deemed likely to result in surgery or hospitalization.
- •Patients with a history of trauma resulting in head injury related seizures, or with epilepsy (except a prior history of febrile seizures of infancy which are not exclusionary).
- •Pregnant or lactating women or those of childbearing potential not using medically accepted forms of contraception will be excluded.
- •Concurrent use of other antidepressants, benzodiazepines or antipsychotic medications.
- •Patients with a history of hypersensitivity to escitalopram are excluded.
- •Individuals must have discontinued MAO inhibitors more than 14 days before starting study drug.
- •Additional contraindicated drugs during the study are pimozide, furazolidine, isocarboxazid, lazabemide, and St. John's Wort.
- •Participants meeting DSM-IV or SCID criteria for a substance use disorder in the last six months other than nicotine dependence and those with a positive toxicology screen at baseline consistent with evidence of current substance abuse or dependence as determined by clinical interview.
- •A lifetime history of Bipolar or any psychotic disorder is excluded.
- •Current claustrophobia is exclusionary.
- •Patients currently taking any narcotic will be excluded.
研究组 & 干预措施
Active medication
Escitalopram 10mg/day
干预措施: Escitalopram (Drug)
Placebo
Matched pill placebo
干预措施: Escitalopram (Drug)
结局指标
主要结局
Physiological Reactivity as Measured by Square-root Transformed Skin Conductance Conditioned Response in Early Extinction Trials 1 to 4
时间窗: Day 2 of Fear Conditioning Paradigm (15 to 18 days post medication initiation)
Three-way interaction between group (active vs. placebo), CS (+ vs. -), and trials (1 - 4). CS+ refers to the conditioned stimulus associated with the unconditioned stimulus (electric shock). Higher numbers reflect higher skin conductance response to the CS+ (conditioned stimulus). CS- refers to the stimulus not associated with the unconditioned stimulus. Higher numbers reflect higher skin conductance response to a CS-. Square-root transformed skin conductance conditioned response are reported for trials 1 to 4 of the Early Extinction Phase.
Physiological Reactivity as Measured by Square-root Transformed Skin Conductance Conditioned Response in Acquisition Trials 1 to 5
时间窗: Baseline on Day 1 of Fear Conditioning Paradigm (14 to 17 days post medication initiation)
Three-way interaction between group (active vs. placebo), CS (+ vs. -), and trials (1 - 5). CS+ refers to the conditioned stimulus associated with the unconditioned stimulus (electric shock). Higher numbers reflect higher skin conductance response to the CS+ (conditioned stimulus). CS- refers to the stimulus not associated with the unconditioned stimulus. Higher numbers reflect higher skin conductance response to a CS-. Square-root transformed skin conductance conditioned response are reported for trials 1 to 5 of the Acquisition Phase.
次要结局
未报告次要终点
研究者
Naomi M. Simon
Principal Investigator
Massachusetts General Hospital