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临床试验/NCT03031405
NCT03031405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

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2017年1月15日最近更新:
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
220
试验地点
1
主要终点
Intrusive memories

研究概览

简要总结

The purpose of the study is to examine whether oxytocin and oxytocin receptor gene polymorphism 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 44 Years(Adult)
性别
Female
接受健康志愿者

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

干预措施: Oxytocin nasal spray (Drug)

Placebo and trauma film paradigm

Placebo Comparator

干预措施: Placebos (Drug)

结局指标

主要结局

Intrusive memories

时间窗: four consecutive days

Influence of oxytocin 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)
  • Genetic polymorphism(four consecutive days)
  • Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L)(Day 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Katharina Schultebraucks

PhD

Charite University, Berlin, Germany

研究点 (1)

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