The Effect of Estradiol on the Acquisition and Consolidation of Trauma-Associated Memories
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 273
- 试验地点
- 1
- 主要终点
- Change of Intrusive Memories in the following four days after the intervention
研究概览
简要总结
The aim of the current project is to investigate the impact of 3mg of oral estradiol valerate on the formation of intrusive memories after analog trauma.
A well-established stress-film paradigm will be used to induce intrusive symptoms in healthy participants. In a double-blind placebo-controlled study, the impact of oral estradiol on intrusive symptoms during and immediately after exposure to a trauma film will be examined. The primary hypothesis is that exogenous oral estradiol will decrease the number of intrusive memories recorded in the four days following experimental trauma compared with placebo controls.
This project will contribute to the current understanding of intrusive memory formation in PTSD and may guide the development of future pharmacological preventions.
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, randomized, placebo controlled
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy female volunteers
- •German on B1 level
排除标准
- •former or present disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5)
- •any physical illnesses
- •any medication intake (except oral contraceptive)
- •history of traumatic experience, e.g. history of sexual abuse or rape
- •pregnancy or lactation period
- •intake of oral contraceptives
- •follicular phase of menstrual cycle
研究组 & 干预措施
Estradiol before the trauma paradigme
3mg of oral estradiol valerate administered two hours before the trauma film (during acquisition of trauma associated memories)
干预措施: Estradiol Valerate (Drug)
Estradiol after the trauma paradigme
3mg of oral estradiol valerate administered immediately after the trauma film (during consolidation of trauma associated memories)
干预措施: Estradiol Valerate (Drug)
Placebo before and after the trauma film paradigm
干预措施: Placebo (Drug)
结局指标
主要结局
Change of Intrusive Memories in the following four days after the intervention
时间窗: four consecutive days
Influence of estradiol on the development of intrusive memories measured with an intrusion diary
次要结局
- Noradrenergic System (measured with salivary alpha-amylase - u/ml)(Day 1)
- Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L)(Day 1)
- Estradiol and Progesterone(Day 1)
- heart rate variability(Day 1)
研究者
Stefan Roepke
Prof. Dr.
Charite University, Berlin, Germany