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

Charité University Medicine Berlin

Status: Completed

Conditions: Borderline Personality Disorder

Treatments: Behavioral: Trier Social Stress Test (TSST); Drug: Placebo; Behavioral: Placebo Trier Social Stress Test (P-TSST); Drug: Fludrocortisone

Study type: Interventional

Funder types: Other

Identifiers

NCT05310253

WI 3396/12-1.2

Details and patient eligibility

About

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).

Full 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.

Enrollment: 240 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Factorial Assignment

Masking: Triple Blind

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240 participants in 8 patient groups

Fludrocortisone & TSST - BPD patients

Experimental group

Description:

intake of 0.4mg fludrocortisone (orally) before stress

Treatment:

Drug: Fludrocortisone

Behavioral: Trier Social Stress Test (TSST)

Fludrocortisone & TSST - Healthy controls

Experimental group

Description:

intake of 0.4mg fludrocortisone (orally) before stress

Treatment:

Drug: Fludrocortisone

Behavioral: Trier Social Stress Test (TSST)

Placebo pills & TSST - BPD patients

Experimental group

Description:

intake of placebo pill before stress

Treatment:

Drug: Placebo

Behavioral: Trier Social Stress Test (TSST)

Placebo pills & TSST - Healthy controls

Experimental group

Description:

intake of placebo pill before stress

Treatment:

Drug: Placebo

Behavioral: Trier Social Stress Test (TSST)

Fludrocortisone & Placebo-TSST- BPD patients

Experimental group

Description:

intake of 0.4mg fludrocortisone (orally) before "no stress"

Treatment:

Drug: Fludrocortisone

Behavioral: Placebo Trier Social Stress Test (P-TSST)

Fludrocortisone & Placebo-TSST - Healthy controls

Experimental group

Description:

intake of 0.4mg fludrocortisone (orally) before "no stress"

Treatment:

Drug: Fludrocortisone

Behavioral: Placebo Trier Social Stress Test (P-TSST)

Placebo pills & Placebo-TSST - BPD patients

Experimental group

Description:

intake of placebo pill before "no stress"

Treatment:

Behavioral: Placebo Trier Social Stress Test (P-TSST)

Placebo pills & Placebo-TSST - Healthy controls

Experimental group

Description:

intake of placebo pill before "no stress"

Treatment:

Behavioral: Placebo Trier Social Stress Test (P-TSST)

Drug: Placebo