NCT05310253

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 14, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

3.1 years

First QC Date

March 14, 2022

Last Update Submit

March 4, 2025

Conditions

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Sharing behavior

    10 minutes after (P-)TSST

  • Punishment behavior

    10 minutes after (P-)TSST

Other Outcomes (3)

  • salivary cortisol

    3 hours

  • salivary alpha amylase

    3 hours

  • sex hormones

    3 hours

Study Arms (8)

Fludrocortisone & TSST - BPD patients

EXPERIMENTAL

intake of 0.4mg fludrocortisone (orally) before stress

Drug: FludrocortisoneBehavioral: Trier Social Stress Test (TSST)

Fludrocortisone & TSST - Healthy controls

EXPERIMENTAL

intake of 0.4mg fludrocortisone (orally) before stress

Drug: FludrocortisoneBehavioral: Trier Social Stress Test (TSST)

Placebo pills & TSST - BPD patients

EXPERIMENTAL

intake of placebo pill before stress

Drug: PlaceboBehavioral: Trier Social Stress Test (TSST)

Placebo pills & TSST - Healthy controls

EXPERIMENTAL

intake of placebo pill before stress

Drug: PlaceboBehavioral: Trier Social Stress Test (TSST)

Fludrocortisone & Placebo-TSST- BPD patients

EXPERIMENTAL

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

Drug: FludrocortisoneBehavioral: Placebo Trier Social Stress Test (P-TSST)

Fludrocortisone & Placebo-TSST - Healthy controls

EXPERIMENTAL

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

Drug: FludrocortisoneBehavioral: Placebo Trier Social Stress Test (P-TSST)

Placebo pills & Placebo-TSST - BPD patients

EXPERIMENTAL

intake of placebo pill before "no stress"

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

Placebo pills & Placebo-TSST - Healthy controls

EXPERIMENTAL

intake of placebo pill before "no stress"

Drug: PlaceboBehavioral: Placebo Trier Social Stress Test (P-TSST)

Interventions

FludrocortisoneDRUG

pill of fludrocortisone

Fludrocortisone & Placebo-TSST - Healthy controlsFludrocortisone & Placebo-TSST- BPD patientsFludrocortisone & TSST - BPD patientsFludrocortisone & TSST - Healthy controls
PlaceboDRUG

placebo pill

Placebo pills & Placebo-TSST - Healthy controlsPlacebo pills & TSST - BPD patientsPlacebo pills & TSST - Healthy controls
Trier Social Stress Test (TSST)BEHAVIORAL

psychosocial stress induction

Also known as: Stress
Fludrocortisone & TSST - BPD patientsFludrocortisone & TSST - Healthy controlsPlacebo pills & TSST - BPD patientsPlacebo pills & TSST - Healthy controls
Placebo Trier Social Stress Test (P-TSST)BEHAVIORAL

control condition

Also known as: no stress
Fludrocortisone & Placebo-TSST - Healthy controlsFludrocortisone & Placebo-TSST- BPD patientsPlacebo pills & Placebo-TSST - BPD patientsPlacebo pills & Placebo-TSST - Healthy controls

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • acute depressive episode,
  • acute or lifetime psychotic symptoms
  • acute substance abuse
  • physical illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite University

Berlin, Germany

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

FludrocortisonePsychological Tests

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

HydrocortisonePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
"Fight-or-flight" versus "tend-and-befriend" response to behavioral and pharmacological interventions in patients with borderline personality disorder

Study Record Dates

First Submitted

March 14, 2022

First Posted

April 4, 2022

Study Start

February 1, 2022

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

March 6, 2025

Record last verified: 2025-03

Locations

DE(1)