"The Effects of Oxytocin on Patients With Borderline Personality Disorder"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- BPD Symptoms
研究概览
简要总结
RCT. Two substudies (clinical and experimental). Main objective of the trial is to examine if oxytocin, compared to placebo shows any additional effect on the therapy achievements (outcome) of patients with borderline personality disorder, who receive an in-patient standard psychotherapy (Dialectical-behavioral-therapy, Marsha Linehan (2006)).
Secondary objectives :
Investigate if oxytocin compared to placebo enhances social trust and emotion recognition in patients with borderline personality disorder. Comparison of the effects of Oxytocin on patients with BPD and major depression.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gender: Both, male and female
- •Minimum Age: 18 Years
- •Maximum Age: 50 Years
- •Borderline personality disorder or major depression (clinical control group)
- •Mini Mental Status Test > 27 (capacity to consent)
排除标准
- •chronic or acute somatic health problems
- •Schizophrenia
- •Bipolar affective disorder
- •pregnancy
- •breast feeding
- •neurological disorder
- •allergy to antidegradants
研究组 & 干预措施
Oxytocin
Oxytocin
干预措施: Oxytocin (Drug)
Placebo
Placebo
干预措施: placebo (Other)
结局指标
主要结局
BPD Symptoms
时间窗: BPD Symptoms
次要结局
未报告次要终点
研究者
Prof. Dr. Markus Heinrichs
Prof. Dr. Markus Heinrichs
University of Freiburg