Stress & Social Cognition in BPD (part 2)

NCT ID: NCT05310253

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2025-03-01

Brief Summary

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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

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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.

Conditions

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Borderline Personality Disorder

Study Design

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Allocation Method

NA

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Fludrocortisone & TSST - BPD patients

intake of 0.4mg fludrocortisone (orally) before stress

Group Type EXPERIMENTAL

Fludrocortisone

Intervention Type DRUG

pill of fludrocortisone

Trier Social Stress Test (TSST)

Intervention Type BEHAVIORAL

psychosocial stress induction

Fludrocortisone & TSST - Healthy controls

intake of 0.4mg fludrocortisone (orally) before stress

Group Type EXPERIMENTAL

Fludrocortisone

Intervention Type DRUG

pill of fludrocortisone

Trier Social Stress Test (TSST)

Intervention Type BEHAVIORAL

psychosocial stress induction

Placebo pills & TSST - BPD patients

intake of placebo pill before stress

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

placebo pill

Trier Social Stress Test (TSST)

Intervention Type BEHAVIORAL

psychosocial stress induction

Placebo pills & TSST - Healthy controls

intake of placebo pill before stress

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

placebo pill

Trier Social Stress Test (TSST)

Intervention Type BEHAVIORAL

psychosocial stress induction

Fludrocortisone & Placebo-TSST- BPD patients

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

Group Type EXPERIMENTAL

Fludrocortisone

Intervention Type DRUG

pill of fludrocortisone

Placebo Trier Social Stress Test (P-TSST)

Intervention Type BEHAVIORAL

control condition

Fludrocortisone & Placebo-TSST - Healthy controls

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

Group Type EXPERIMENTAL

Fludrocortisone

Intervention Type DRUG

pill of fludrocortisone

Placebo Trier Social Stress Test (P-TSST)

Intervention Type BEHAVIORAL

control condition

Placebo pills & Placebo-TSST - BPD patients

intake of placebo pill before "no stress"

Group Type EXPERIMENTAL

Placebo Trier Social Stress Test (P-TSST)

Intervention Type BEHAVIORAL

control condition

Placebo pills & Placebo-TSST - Healthy controls

intake of placebo pill before "no stress"

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

placebo pill

Placebo Trier Social Stress Test (P-TSST)

Intervention Type BEHAVIORAL

control condition

Interventions

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Fludrocortisone

pill of fludrocortisone

Intervention Type DRUG

Placebo

placebo pill

Intervention Type DRUG

Trier Social Stress Test (TSST)

psychosocial stress induction

Intervention Type BEHAVIORAL

Placebo Trier Social Stress Test (P-TSST)

control condition

Intervention Type BEHAVIORAL

Other Intervention Names

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Stress no stress

Eligibility Criteria

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Inclusion Criteria

* clinical diagnosis of borderline personality disorder
* female
* BMI between 17.5-30


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Katja Wingenfeld

"Fight-or-flight" versus "tend-and-befriend" response to behavioral and pharmacological interventions in patients with borderline personality disorder

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Charite University

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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WI 3396/12-1.2

Identifier Type: -

Identifier Source: org_study_id

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