Stress & Social Cognition in BPD (Part 2)

Study Overview
=================
Brief Summary
-----------------
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).

Detailed Description
-----------------
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.

Official Title
-----------------
Fight-or-flight Versus Tend-and-befriend Response to Behavioral and Pharmacological Interventions in Patients With Borderline Personality Disorder (Part II)

Conditions
-----------------
Borderline Personality Disorder

Intervention / Treatment
-----------------
* Drug: Fludrocortisone
* Drug: Placebo
* Behavioral: Trier Social Stress Test (TSST)
* Behavioral: Placebo Trier Social Stress Test (P-TSST)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria BPD group: clinical diagnosis of borderline personality disorder female BMI between 17.5-30 Inclusion Criteria control group: female BMI between 17.5-30 no clinical diagnosis of any mental disorder Exclusion Criteria: acute depressive episode, acute or lifetime psychotic symptoms acute substance abuse physical illness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fludrocortisone & TSST - BPD patients<br>intake of 0.4mg fludrocortisone (orally) before stress | Drug: Fludrocortisone<br>* pill of fludrocortisone<br>Behavioral: Trier Social Stress Test (TSST)<br>* psychosocial stress induction<br>* Other names: Stress;|
| Experimental: Fludrocortisone & TSST - Healthy controls<br>intake of 0.4mg fludrocortisone (orally) before stress | Drug: Fludrocortisone<br>* pill of fludrocortisone<br>Behavioral: Trier Social Stress Test (TSST)<br>* psychosocial stress induction<br>* Other names: Stress;|
| Experimental: Placebo pills & TSST - BPD patients<br>intake of placebo pill before stress | Drug: Placebo<br>* placebo pill<br>Behavioral: Trier Social Stress Test (TSST)<br>* psychosocial stress induction<br>* Other names: Stress;|
| Experimental: Placebo pills & TSST - Healthy controls<br>intake of placebo pill before stress | Drug: Placebo<br>* placebo pill<br>Behavioral: Trier Social Stress Test (TSST)<br>* psychosocial stress induction<br>* Other names: Stress;|
| Experimental: Fludrocortisone & Placebo-TSST- BPD patients<br>intake of 0.4mg fludrocortisone (orally) before no stress | Drug: Fludrocortisone<br>* pill of fludrocortisone<br>Behavioral: Placebo Trier Social Stress Test (P-TSST)<br>* control condition<br>* Other names: no stress;|
| Experimental: Fludrocortisone & Placebo-TSST - Healthy controls<br>intake of 0.4mg fludrocortisone (orally) before no stress | Drug: Fludrocortisone<br>* pill of fludrocortisone<br>Behavioral: Placebo Trier Social Stress Test (P-TSST)<br>* control condition<br>* Other names: no stress;|
| Experimental: Placebo pills & Placebo-TSST - BPD patients<br>intake of placebo pill before no stress | Behavioral: Placebo Trier Social Stress Test (P-TSST)<br>* control condition<br>* Other names: no stress;|
| Experimental: Placebo pills & Placebo-TSST - Healthy controls<br>intake of placebo pill before no stress | Drug: Placebo<br>* placebo pill<br>Behavioral: Placebo Trier Social Stress Test (P-TSST)<br>* control condition<br>* Other names: no stress;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Empathy: Multifaceted Empathy Test | correct answers (mental state of the subject in the photos), rating of own emotional reaction | 15 minutes after (P-)TSST | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sharing behavior | amount of monetary units (max 100) shared with co-player | 10 minutes after (P-)TSST | 
| Punishment behavior | number of rejected offers from co-player | 10 minutes after (P-)TSST |