"Fight-or-flight" Versus "tend-and-befriend" Response to Behavioral and Pharmacological Interventions in Patients with Borderline Personality Disorder (Part II)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Empathy: Multifaceted Empathy Test
研究概览
简要总结
The investigators will examine how a combination of pharmacological mineralocorticoid receptor (MR) stimulation and psychosocial stress will influence prosocial behavior in patients with Borderline Personality Disorder (BPD) compared to healthy controls (HC).
详细描述
The investigators will examine whether MR stimulation enhances prosocial behavior in BPD patients under additional psychosocial stress. Participants will be randomly assigned to receive either fludrocortisone as an MR stimulant or placebo. Afterwards, participants will either undergo the stress or placebo condition of the Trier Social Stress Test ((P-)TSST). Subsequently, cognitive and emotional empathy, as well as sharing and punishment behavior will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •acute depressive episode,
- •acute or lifetime psychotic symptoms
- •acute substance abuse
- •physical illness
研究组 & 干预措施
Placebo pills & TSST - Healthy controls
intake of placebo pill before stress
干预措施: Placebo (Drug)
Fludrocortisone & TSST - BPD patients
intake of 0.4mg fludrocortisone (orally) before stress
干预措施: Fludrocortisone (Drug)
Fludrocortisone & TSST - BPD patients
intake of 0.4mg fludrocortisone (orally) before stress
干预措施: Trier Social Stress Test (TSST) (Behavioral)
Fludrocortisone & TSST - Healthy controls
intake of 0.4mg fludrocortisone (orally) before stress
干预措施: Fludrocortisone (Drug)
Fludrocortisone & TSST - Healthy controls
intake of 0.4mg fludrocortisone (orally) before stress
干预措施: Trier Social Stress Test (TSST) (Behavioral)
Placebo pills & TSST - BPD patients
intake of placebo pill before stress
干预措施: Placebo (Drug)
Placebo pills & TSST - BPD patients
intake of placebo pill before stress
干预措施: Trier Social Stress Test (TSST) (Behavioral)
Placebo pills & TSST - Healthy controls
intake of placebo pill before stress
干预措施: Trier Social Stress Test (TSST) (Behavioral)
Fludrocortisone & Placebo-TSST- BPD patients
intake of 0.4mg fludrocortisone (orally) before "no stress"
干预措施: Fludrocortisone (Drug)
Fludrocortisone & Placebo-TSST- BPD patients
intake of 0.4mg fludrocortisone (orally) before "no stress"
干预措施: Placebo Trier Social Stress Test (P-TSST) (Behavioral)
Fludrocortisone & Placebo-TSST - Healthy controls
intake of 0.4mg fludrocortisone (orally) before "no stress"
干预措施: Fludrocortisone (Drug)
Fludrocortisone & Placebo-TSST - Healthy controls
intake of 0.4mg fludrocortisone (orally) before "no stress"
干预措施: Placebo Trier Social Stress Test (P-TSST) (Behavioral)
Placebo pills & Placebo-TSST - BPD patients
intake of placebo pill before "no stress"
干预措施: Placebo Trier Social Stress Test (P-TSST) (Behavioral)
Placebo pills & Placebo-TSST - Healthy controls
intake of placebo pill before "no stress"
干预措施: Placebo (Drug)
Placebo pills & Placebo-TSST - Healthy controls
intake of placebo pill before "no stress"
干预措施: Placebo Trier Social Stress Test (P-TSST) (Behavioral)
结局指标
主要结局
Empathy: Multifaceted Empathy Test
时间窗: 15 minutes after (P-)TSST
correct answers (mental state of the subject in the photos), rating of own emotional reaction
次要结局
- Sharing behavior(10 minutes after (P-)TSST)
- Punishment behavior(10 minutes after (P-)TSST)
研究者
Katja Wingenfeld
"Fight-or-flight" versus "tend-and-befriend" response to behavioral and pharmacological interventions in patients with borderline personality disorder
Charite University, Berlin, Germany