Stress & Social Cognition in BPD (part 2)

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05310253

Acronym

SOKO-2

Enrollment

240

Registered

2022-04-04

Start date

2022-02-01

Completion date

2025-03-01

Last updated

2025-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Borderline Personality Disorder

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.

Interventions

DRUGFludrocortisone

pill of fludrocortisone

DRUGPlacebo

placebo pill

BEHAVIORALTrier Social Stress Test (TSST)

psychosocial stress induction

BEHAVIORALPlacebo Trier Social Stress Test (P-TSST)

control condition

Study design

Allocation

Intervention model

FACTORIAL

Primary purpose

OTHER

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Other

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026