Stress & Social Cognition in BPD (Part 2)

Borderline Personality Disorder Clinical Trial

— SOKO-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05310253
• Other study ID #: WI 3396/12-1.2
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: December 22, 2023

Study information

• Verified date: July 2023
• Source: Charite University, Berlin, Germany
• Contact: Katja Wingenfeld
• Phone: 004930450517534
• Email: katja.wingenfeld[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 22, 2023
• Est. primary completion date: December 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

Drug:
• Fludrocortisone
pill of fludrocortisone
• Placebo
placebo pill

Behavioral:
• Trier Social Stress Test (TSST)
psychosocial stress induction
• Placebo Trier Social Stress Test (P-TSST)
control condition

Locations

Country	Name	City	State
Germany	Charite University	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	salivary cortisol	treatment check	3 hours
Other	salivary alpha amylase	treatment check	3 hours
Other	sex hormones	testosterone, estrogen, progesterone	3 hours
Primary	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	Sharing behavior	amount of monetary units (max 100) shared with co-player	10 minutes after (P-)TSST
Secondary	Punishment behavior	number of rejected offers from co-player	10 minutes after (P-)TSST