The Effect of 21-Days Intranasal Oxytocin on Clinical Symptoms and Social Function in Patients With Post Traumatic Stress Disorder (PTSD), a Randomized Controled Trail
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 主要终点
- Semi-structured interviews (CAPS)and self-report questionnaires that examine the symptoms of the disorder and related symptoms (social function and aggressive behavior)
研究概览
简要总结
Oxytocin (OT) - a neurohormone and neuromodulator which is mainly synthesized in the hypothalamus - is a mediator stress regulation and improves social bonding. 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. In two current studies that were conducted in Rambam health care we found that a single dose of intranasal OT reduces anxiety and irritability symptoms, and enhances emotional empathy and compassion, in patients with PTSD. The main goal of this study is to examine the effects of 21-days intranasal Oxytocin on clinical symptoms and social function in these patients.
详细描述
This study will examine the effect is of 21-days intranasal Oxytocin on clinical symptoms and social function in these patients, in a double blind (treatment/placebo) study design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PTSD patients (DSM-IV criteria)
- •Ability to provide written informed consent
排除标准
- •Suicidality
- •Psychosis
- •Borderline Personality
- •Arrhythmia
- •Cardiac disease (arrythmia, heart failure)
- •Hyponatremia
- •Hypertension
- •Severe renal insufficiency
- •Liver cirrhosis
- •Lactating or pregnant women, or undergoing fertility treatment
研究组 & 干预措施
Placebo treatments
Other: Placebo treatments- 20 PTSD patients
干预措施: PLACEBO (Drug)
intervention
intervention: Oxytoine treatments - 20 PTSD patients
干预措施: Oxytoine (Drug)
结局指标
主要结局
Semi-structured interviews (CAPS)and self-report questionnaires that examine the symptoms of the disorder and related symptoms (social function and aggressive behavior)
时间窗: 3 weeks
次要结局
未报告次要终点