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OpenTrials
Completed

NCT Number: NCT05310253

Stress & Social Cognition in BPD (part 2)

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).

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Key information

Conditions

Borderline Personality Disorder Mental Disorders Personality Disorders

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Charite University

Berlin, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fludrocortisone

Drug

pill of fludrocortisone

Placebo

Drug

placebo pill

Trier Social Stress Test (TSST)

Behavioral

psychosocial stress induction

Other names: Stress

Placebo Trier Social Stress Test (P-TSST)

Behavioral

control condition

Other names: no stress

Primary outcomes

  1. Empathy: Multifaceted Empathy Test

    Time frame: 15 minutes after (P-)TSST

    correct answers (mental state of the subject in the photos), rating of own emotional reaction

Secondary outcomes

  1. Sharing behavior

    Time frame: 10 minutes after (P-)TSST

    amount of monetary units (max 100) shared with co-player

  2. Punishment behavior

    Time frame: 10 minutes after (P-)TSST

    number of rejected offers from co-player

Other outcomes

  1. salivary cortisol

    Time frame: 3 hours

    treatment check

  2. salivary alpha amylase

    Time frame: 3 hours

    treatment check

  3. sex hormones

    Time frame: 3 hours

    testosterone, estrogen, progesterone

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: SOKO-2

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2022
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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