Stress & Social Cognition in BPD (part 2) (SOKO-2)

"Fight-or-flight" Versus "tend-and-befriend" Response to Behavioral and Pharmacological Interventions in Patients with Borderline Personality Disorder (Part II)

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).

Study Overview

• Status: Completed
• Conditions: Borderline Personality Disorder
• Intervention / Treatment: Drug: Placebo; Drug: Fludrocortisone; Behavioral: Trier Social Stress Test (TSST); Behavioral: Placebo Trier Social Stress Test (P-TSST)

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.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Charité university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

8

Arms and Interventions

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
salivary cortisol	treatment check	3 hours
salivary alpha amylase	treatment check	3 hours
sex hormones	testosterone, estrogen, progesterone	3 hours

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Borderline Personality Disorder; Anti-Inflammatory Agents; Fludrocortisone
• Other Study ID Numbers: WI 3396/12-1.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No