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Stress & Social Cognition in BPD (Part 2) (SOKO-2)

Primary Purpose

Borderline Personality Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Fludrocortisone
Placebo
Trier Social Stress Test (TSST)
Placebo Trier Social Stress Test (P-TSST)
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Borderline Personality Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Charite UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Fludrocortisone & TSST - BPD patients

Fludrocortisone & TSST - Healthy controls

Placebo pills & TSST - BPD patients

Placebo pills & TSST - Healthy controls

Fludrocortisone & Placebo-TSST- BPD patients

Fludrocortisone & Placebo-TSST - Healthy controls

Placebo pills & Placebo-TSST - BPD patients

Placebo pills & Placebo-TSST - Healthy controls

Arm Description

intake of 0.4mg fludrocortisone (orally) before stress

intake of 0.4mg fludrocortisone (orally) before stress

intake of placebo pill before stress

intake of placebo pill before stress

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

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

intake of placebo pill before "no stress"

intake of placebo pill before "no stress"

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Sharing behavior
amount of monetary units (max 100) shared with co-player
Punishment behavior
number of rejected offers from co-player

Full Information

First Posted
March 14, 2022
Last Updated
July 17, 2023
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT05310253
Brief Title
Stress & Social Cognition in BPD (Part 2)
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
December 22, 2023 (Anticipated)
Study Completion Date
December 22, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fludrocortisone & TSST - BPD patients
Arm Type
Experimental
Arm Description
intake of 0.4mg fludrocortisone (orally) before stress
Arm Title
Fludrocortisone & TSST - Healthy controls
Arm Type
Experimental
Arm Description
intake of 0.4mg fludrocortisone (orally) before stress
Arm Title
Placebo pills & TSST - BPD patients
Arm Type
Experimental
Arm Description
intake of placebo pill before stress
Arm Title
Placebo pills & TSST - Healthy controls
Arm Type
Experimental
Arm Description
intake of placebo pill before stress
Arm Title
Fludrocortisone & Placebo-TSST- BPD patients
Arm Type
Experimental
Arm Description
intake of 0.4mg fludrocortisone (orally) before "no stress"
Arm Title
Fludrocortisone & Placebo-TSST - Healthy controls
Arm Type
Experimental
Arm Description
intake of 0.4mg fludrocortisone (orally) before "no stress"
Arm Title
Placebo pills & Placebo-TSST - BPD patients
Arm Type
Experimental
Arm Description
intake of placebo pill before "no stress"
Arm Title
Placebo pills & Placebo-TSST - Healthy controls
Arm Type
Experimental
Arm Description
intake of placebo pill before "no stress"
Intervention Type
Drug
Intervention Name(s)
Fludrocortisone
Intervention Description
pill of fludrocortisone
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo pill
Intervention Type
Behavioral
Intervention Name(s)
Trier Social Stress Test (TSST)
Other Intervention Name(s)
Stress
Intervention Description
psychosocial stress induction
Intervention Type
Behavioral
Intervention Name(s)
Placebo Trier Social Stress Test (P-TSST)
Other Intervention Name(s)
no stress
Intervention Description
control condition
Primary Outcome Measure Information:
Title
Empathy: Multifaceted Empathy Test
Description
correct answers (mental state of the subject in the photos), rating of own emotional reaction
Time Frame
15 minutes after (P-)TSST
Secondary Outcome Measure Information:
Title
Sharing behavior
Description
amount of monetary units (max 100) shared with co-player
Time Frame
10 minutes after (P-)TSST
Title
Punishment behavior
Description
number of rejected offers from co-player
Time Frame
10 minutes after (P-)TSST
Other Pre-specified Outcome Measures:
Title
salivary cortisol
Description
treatment check
Time Frame
3 hours
Title
salivary alpha amylase
Description
treatment check
Time Frame
3 hours
Title
sex hormones
Description
testosterone, estrogen, progesterone
Time Frame
3 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katja Wingenfeld
Phone
004930450517534
Email
katja.wingenfeld@charite.de
Facility Information:
Facility Name
Charite University
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katja Wingenfeld, PhD
Phone
004930450517534
Email
katja.wingenfeld@charite.de

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Stress & Social Cognition in BPD (Part 2)

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