The Influence of Estrogen on the Fear Extinction Network in Humans-R61
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Impact of exogenous administration of estradiol on the neural correlates of fear extinction
研究概览
简要总结
The goal of this project is to examine how estrogen may influence the resting-state connectivity and the extinction-induced activation of the fear extinction network.
详细描述
The aim of the study was to examine the influence of exogenous estrogen administration on the activation of the fear extinction network in women. Functional MRI data and psychophysiological indices were collected to test the influence of estrogen on women's ability to regulate conditioned fear responses. Women underwent a 3 day experimental paradigm using classical fear conditioning. The first day was conducted outside the scanner, while days 2 and 3 were done inside the fMRI scanner and tested fear extinction learning and recall in days 2 and 3, respectively. The estrogen (or placebo) pill was given just hours before extinction learning test on day 2. No followups were conducted after women completed the 3 day study.
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)
盲法说明
double blind placebo control study
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Right-handed (Edinburgh Inventory - Oldfield 1971).
- •SCID diagnosis consistent with none, current or past history of Axis I psychiatric disorders.
- •To be matched for age, gender, and years of education, as well as self-identified race/ethnicity.
- •For naturally cycling female subjects, stage of menstrual cycle will be ascertained by history, and by serological measures.
- •For women on oral contraceptives, we will identify those using 20mcg ethinyl, 2nd or 3rd generation, monophasic
排除标准
- •Psychiatric, neurologic or medical condition that would interfere with study procedures or confound results, ascertained by history.
- •History of seizure or significant head trauma (i.e., extended loss of consciousness, neurological sequelae, or known structural brain lesion).
- •History of Axis I psychiatric diagnosis; e.g., history of substance use disorder, psychotic disorder, bipolar disorder, tic disorder, or eating disorder.
- •Use of psychotropic medication within 4 weeks prior to study (within 6 weeks for fluoxetine, or other long-lived compounds; within one year for neuroleptics).
- •Pregnancy (to be ruled out by urine ß-HCG).
- •Metallic implants or devices contraindicating magnetic resonance imaging.
- •Use of oral contraceptives or non-oral contraceptives containing estrogen and progesterone within 3 months
- •History of breast cancer.
- •Allergy to peanut oil.
研究组 & 干预措施
Estradiol 4mg Dose
4mg dose of estradiol (oral administration)
干预措施: Estradiol 4Mg Tablet (Drug)
Placebo
placebo (oral administration)
干预措施: Placebo Pills (Drug)
Estradiol 2mg Dose
2mg dose of estradiol (oral administration)
干预措施: Estradiol 2Mg Tablet (Drug)
结局指标
主要结局
Impact of exogenous administration of estradiol on the neural correlates of fear extinction
时间窗: 3 Days
BOLD responses during fear extinction after taking estradiol or placebo
次要结局
未报告次要终点