The Effect of Intranasal Oxytocin on Emphatic Abilities in Patients With PTSD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Computer tasks that assess empathy, Another goal of this study is to examine the relationship between empathic abilities and the ability to retrieve autobiographical memories among PTSD patients.
研究概览
简要总结
Oxytocin (OT) - a neurohormone and neuromodulator which is mainly synthesized in the hypothalamus - is a key mediator of complex social and affective behaviors, including emotional empathy. Recently, several theoretical studies suggested that PTSD patients have abnormal functioning of the OT system. According to these theories, dysfunction in the oxytocin system may modulate the interpersonal impairment that characterizes PTSD, and therefore intranasal OT may potentially relieve these symptoms. The main goal of this study is to examine the effects of administration of nasal OT on empathic abilities among PTSD patients. Another goal of this study is to examine the relationship between empathic abilities and the ability to retrieve autobiographical memories among PTSD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PTSD patients (DSM-IV criteria)
- •Ability to provide written informed consent
排除标准
- •Suicidality
- •Psychosis
- •Arrhythmia
- •Cardiac disease (arrythmia, heart failure)
- •Hyponatremia
- •Severe renal insufficiency
- •Liver cirrhosis
- •Pregnancy
研究组 & 干预措施
study group
32 PTSD patients intervention: Drug: syntocinon nasal spray / placebo nasal spray nasal OT - 24 IU, 3 inhalations of 4IU to each nostril (45 sec waiting between the inhalations)
干预措施: syntocinon nasal spray (Drug)
study group
32 PTSD patients intervention: Drug: syntocinon nasal spray / placebo nasal spray nasal OT - 24 IU, 3 inhalations of 4IU to each nostril (45 sec waiting between the inhalations)
干预措施: placebo nasal spray (Drug)
control group
control group - 30 healthy control subjects intervention: Drug: syntocinon nasal spray / placebo nasal spray nasal OT - 24 IU, 3 inhalations of 4IU to each nostril (45 sec waiting between the inhalations)
干预措施: syntocinon nasal spray (Drug)
control group
control group - 30 healthy control subjects intervention: Drug: syntocinon nasal spray / placebo nasal spray nasal OT - 24 IU, 3 inhalations of 4IU to each nostril (45 sec waiting between the inhalations)
干预措施: placebo nasal spray (Drug)
结局指标
主要结局
Computer tasks that assess empathy, Another goal of this study is to examine the relationship between empathic abilities and the ability to retrieve autobiographical memories among PTSD patients.
时间窗: 1 hour after the inhalation the OT
The computer tasks will assess emotional empathy(e.g. task that assess the ability to recognizes emotional facial expressions ('face morphing'), and task that assess the ability to recognizes emotions depicted in a biological motion ('biological motion')), And cognitive empathy ( task that assess the ability to judge mental states based on verbal and eye gaze cues (ToM task)).
次要结局
未报告次要终点