Stress & Social Cognition in BPD (Part 2)

Not Applicable

Recruiting

• Conditions: Borderline Personality Disorder
• Interventions: Drug: Placebo; Drug: Fludrocortisone; Behavioral: Trier Social Stress Test (TSST); Behavioral: Placebo Trier Social Stress Test (P-TSST)

• Registration Number: NCT05310253
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study Start: 2022-02-01
• Study First Submitted: 2022-03-14
• Study First Submitted QC: 2022-03-31
• Study First Posted: 2022-04-04
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

• acute depressive episode,
• acute or lifetime psychotic symptoms
• acute substance abuse
• physical illness

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Fludrocortisone & TSST - BPD patients	Trier Social Stress Test (TSST)	intake of 0.4mg fludrocortisone (orally) before stress
Fludrocortisone & TSST - Healthy controls	Trier Social Stress Test (TSST)	intake of 0.4mg fludrocortisone (orally) before stress
Placebo pills & TSST - BPD patients	Placebo	intake of placebo pill before stress
Placebo pills & TSST - BPD patients	Trier Social Stress Test (TSST)	intake of placebo pill before stress
Placebo pills & TSST - Healthy controls	Placebo	intake of placebo pill before stress
Placebo pills & TSST - Healthy controls	Trier Social Stress Test (TSST)	intake of placebo pill before stress
Fludrocortisone & Placebo-TSST- BPD patients	Fludrocortisone	intake of 0.4mg fludrocortisone (orally) before "no stress"
Fludrocortisone & Placebo-TSST- BPD patients	Placebo Trier Social Stress Test (P-TSST)	intake of 0.4mg fludrocortisone (orally) before "no stress"
Fludrocortisone & Placebo-TSST - Healthy controls	Fludrocortisone	intake of 0.4mg fludrocortisone (orally) before "no stress"
Fludrocortisone & Placebo-TSST - Healthy controls	Placebo Trier Social Stress Test (P-TSST)	intake of 0.4mg fludrocortisone (orally) before "no stress"
Placebo pills & Placebo-TSST - BPD patients	Placebo Trier Social Stress Test (P-TSST)	intake of placebo pill before "no stress"
Placebo pills & Placebo-TSST - Healthy controls	Placebo	intake of placebo pill before "no stress"
Placebo pills & Placebo-TSST - Healthy controls	Placebo Trier Social Stress Test (P-TSST)	intake of placebo pill before "no stress"
Fludrocortisone & TSST - BPD patients	Fludrocortisone	intake of 0.4mg fludrocortisone (orally) before stress
Fludrocortisone & TSST - Healthy controls	Fludrocortisone	intake of 0.4mg fludrocortisone (orally) before stress

Primary Outcome Measures

Name	Time	Method
Empathy: Multifaceted Empathy Test	15 minutes after (P-)TSST	correct answers (mental state of the subject in the photos), rating of own emotional reaction

Secondary Outcome Measures

Name	Time	Method
Sharing behavior	10 minutes after (P-)TSST	amount of monetary units (max 100) shared with co-player
Punishment behavior	10 minutes after (P-)TSST	number of rejected offers from co-player

Trial Locations

Locations (1)

Charite University; 🇩🇪 Berlin, Germany