Borderline Personality DisorderSOKO-2NCT05310253
Stress & Social Cognition in BPD (part 2)
A study testing Fludrocortisone and Trier Social Stress Test (TSST) in people with Borderline Personality Disorder, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Fludrocortisone and Trier Social Stress Test (TSST)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2022to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- acute depressive episode,
- acute or lifetime psychotic symptoms
- acute substance abuse
- physical illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Fight-or-flight" Versus "tend-and-befriend" Response to Behavioral and Pharmacological Interventions in Patients with Borderline Personality Disorder (Part II)
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).
Read the 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.
- Conditions
- Borderline Personality Disorder
- Being tested
- Fludrocortisone, Placebo, Trier Social Stress Test (TSST), Placebo Trier Social Stress Test (P-TSST)
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludrocortisoneDrug
pill of fludrocortisone
PlaceboDrug
placebo pill
Trier Social Stress Test (TSST)Behavioural
Also called Stress
psychosocial stress induction
Placebo Trier Social Stress Test (P-TSST)Behavioural
Also called no stress
control condition
| Study group | Role | What they receive |
|---|---|---|
| Fludrocortisone & TSST - BPD patients | Experimental | intake of 0.4mg fludrocortisone (orally) before stress Receives: Drug: Fludrocortisone; Behavioral: Trier Social Stress Test (TSST) |
| Fludrocortisone & TSST - Healthy controls | Experimental | intake of 0.4mg fludrocortisone (orally) before stress Receives: Drug: Fludrocortisone; Behavioral: Trier Social Stress Test (TSST) |
| Placebo pills & TSST - BPD patients | Experimental | intake of placebo pill before stress Receives: Drug: Placebo; Behavioral: Trier Social Stress Test (TSST) |
| Placebo pills & TSST - Healthy controls | Experimental | intake of placebo pill before stress Receives: Drug: Placebo; Behavioral: Trier Social Stress Test (TSST) |
| Fludrocortisone & Placebo-TSST- BPD patients | Experimental | intake of 0.4mg fludrocortisone (orally) before "no stress" Receives: Drug: Fludrocortisone; Behavioral: Placebo Trier Social Stress Test (P-TSST) |
| Fludrocortisone & Placebo-TSST - Healthy controls | Experimental | intake of 0.4mg fludrocortisone (orally) before "no stress" Receives: Drug: Fludrocortisone; Behavioral: Placebo Trier Social Stress Test (P-TSST) |
| Placebo pills & Placebo-TSST - BPD patients | Experimental | intake of placebo pill before "no stress" Receives: Behavioral: Placebo Trier Social Stress Test (P-TSST) |
| Placebo pills & Placebo-TSST - Healthy controls | Experimental | intake of placebo pill before "no stress" Receives: Drug: Placebo; Behavioral: Placebo Trier Social Stress Test (P-TSST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Empathy: Multifaceted Empathy Test
correct answers (mental state of the subject in the photos), rating of own emotional reaction
Measured: 15 minutes after (P-)TSST
Secondary outcomes (2)
Sharing behavior
amount of monetary units (max 100) shared with co-player
Measured: 10 minutes after (P-)TSST
Punishment behavior
number of rejected offers from co-player
Measured: 10 minutes after (P-)TSST
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start1 Feb 2022
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katja Wingenfeld, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310253
- Sponsor's protocol ID
- WI 3396/12-1.2
- Acronym
- SOKO-2
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2022
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Barthauer M, Graumann L, Cho AB, Kulakova E, Deuter CE, Wolf OT, Hellmann-Regen J, Roepke S, Otte C, Wingenfeld K. Mineralocorticoid receptor stimulation effects on stress-induced cortisol and alpha-amylase in female patients with borderline personality disorder and healthy controls: A randomized placebo-controlled experimental study. J Affect Disord. 2026 Sep 26:122552. doi: 10.1016/j.jad.2026.122552. Online ahead of print.
PubMed 42800510
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Fight-or-flight" Versus "tend-and-befriend" Response to Behavioral and Pharmacological Interventions in Patients with Borderline Personality Disorder (Part II)
- ClinicalTrials.gov ID
- NCT05310253
- Acronym / sponsor ID
- SOKO-2 / WI 3396/12-1.2
- Conditions
- Borderline Personality Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Fludrocortisone & TSST - BPD patients | Experimental | Drug: Fludrocortisone, Behavioral: Trier Social Stress Test (TSST)intake of 0.4mg fludrocortisone (orally) before stress |
| Fludrocortisone & TSST - Healthy controls | Experimental | Drug: Fludrocortisone, Behavioral: Trier Social Stress Test (TSST)intake of 0.4mg fludrocortisone (orally) before stress |
| Placebo pills & TSST - BPD patients | Experimental | Drug: Placebo, Behavioral: Trier Social Stress Test (TSST)intake of placebo pill before stress |
| Placebo pills & TSST - Healthy controls | Experimental | Drug: Placebo, Behavioral: Trier Social Stress Test (TSST)intake of placebo pill before stress |
| Fludrocortisone & Placebo-TSST- BPD patients | Experimental | Drug: Fludrocortisone, Behavioral: Placebo Trier Social Stress Test (P-TSST)intake of 0.4mg fludrocortisone (orally) before "no stress" |
| Fludrocortisone & Placebo-TSST - Healthy controls | Experimental | Drug: Fludrocortisone, Behavioral: Placebo Trier Social Stress Test (P-TSST)intake of 0.4mg fludrocortisone (orally) before "no stress" |
| Placebo pills & Placebo-TSST - BPD patients | Experimental | Behavioral: Placebo Trier Social Stress Test (P-TSST)intake of placebo pill before "no stress" |
| Placebo pills & Placebo-TSST - Healthy controls | Experimental | Drug: Placebo, Behavioral: Placebo Trier Social Stress Test (P-TSST)intake of placebo pill before "no stress" |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- clinical diagnosis of borderline personality disorder
- female
- BMI between 17.5-30
- female
- BMI between 17.5-30
Key exclusion criteria (4 listed)
- acute depressive episode,
- acute or lifetime psychotic symptoms
- acute substance abuse
- physical illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fludrocortisonepill of fludrocortisone | Drug | Fludrocortisone & Placebo-TSST - Healthy controls, Fludrocortisone & Placebo-TSST- BPD patients, Fludrocortisone & TSST - BPD patients, Fludrocortisone & TSST - Healthy controls |
| Placeboplacebo pill | Drug | Placebo pills & Placebo-TSST - Healthy controls, Placebo pills & TSST - BPD patients, Placebo pills & TSST - Healthy controls |
| Trier Social Stress Test (TSST)Also: Stresspsychosocial stress induction | Behavioural | Fludrocortisone & TSST - BPD patients, Fludrocortisone & TSST - Healthy controls, Placebo pills & TSST - BPD patients, Placebo pills & TSST - Healthy controls |
| Placebo Trier Social Stress Test (P-TSST)Also: no stresscontrol condition | Behavioural | Fludrocortisone & Placebo-TSST - Healthy controls, Fludrocortisone & Placebo-TSST- BPD patients, Placebo pills & Placebo-TSST - BPD patients, Placebo pills & Placebo-TSST - Healthy controls |
Primary outcome
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
2 secondary outcomes
Sharing behavior
Time frame: 10 minutes after (P-)TSST
Punishment behavior
Time frame: 10 minutes after (P-)TSST
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Derived from this study: PubMed 42800510Barthauer M, Graumann L, Cho AB, Kulakova E, Deuter CE, Wolf OT, Hellmann-Regen J, Roepke S, Otte C, Wingenfeld K. Mineralocorticoid receptor stimulation effects on stress-induced cortisol and alpha-amylase in female patients with borderline personality disorder and healthy controls: A randomized placebo-controlled experimental study. J Affect Disord. 2026 Sep 26:122552. doi: 10.1016/j.jad.2026.122552. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fludrocortisone and Trier Social Stress Test (TSST) in people with Borderline Personality Disorder, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Empathy: Multifaceted Empathy Test (time frame: 15 minutes after (P-)TSST). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05310253, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.