NCT03875391已完成不适用
The Effect of Oxytocin on the Acquisition and Consolidation of Trauma-Associated Memories: A Model to Understand the Development of Posttraumatic Stress Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 217
- 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 purpose of the study is to examine whether oxytocin and certain polygenic risk scores affect the development of intrusive memories, a cardinal symptom of PTSD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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 a native 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
- •follicular phase of menstrual cycle for all women not using oral contraceptives
研究组 & 干预措施
Oxytocin and trauma film paradigm
Experimental
Intervention: Drug: Oxytocin nasal spray
干预措施: Oxytocin (Drug)
Placebo and trauma film paradigm
Placebo Comparator
Intervention: Drug: Placebos
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 oxytocin on the development of intrusive memories measured with an intrusion diary
次要结局
- Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L)(Day 1)
- Polygenic Risk Score(four consecutive days)
- Noradrenergic System (measured with salivary alpha-amylase - u/ml)(Day 1)
研究者
Stefan Roepke
Principal Investigator, PD Dr.
Charite University, Berlin, Germany
研究点 (1)
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