Borderline Personality DisorderOXT-CORT-BPDNCT05357521
Interplay Between Oxytocin and Cortisol During Stress in Borderline Personality Disorder
An observational study of Borderline Personality Disorder and Oxytocin, run by University of Geneva, Switzerland at 1 site in Switzerland.
Trial summary
This study aims to determine the feasibility and preliminary data on the interaction between oxytocin and cortisol during stress in borderline personnality disorder. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder, Oxytocin
- What is being tested?
- stress test
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2022to 30 Apr 2025
- Phase
- Observational
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Participants with and without borderline personality disorder
Who may be able to join
- Borderline personality disorder-DSM V
Who cannot join
- Schizophrenia
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Young Adult Psychiatric Unit
Geneva, Canton of Geneva, 1202
About this study
Official title: Feasibility and Preliminary Data on the Interplay Between Oxytocin and Cortisol During Stress in Borderline Personality Disorder
This study aims to determine the feasibility and preliminary data on the interaction between oxytocin and cortisol during stress in borderline personnality disorder.
Read the detailed description
The investigators will recruit 50 female patients with borderline personnality disorder and 50 controls with no psychiatric diagnosis, aged between 18 and 25 years old.
salivary cortisol daily curve ( 6 measures during the day) will be measured in participant's naturalistic environnement, together with salivary oxytocin. In addition, salivary oxytocin and cortisol will be measured during a psychosocial stress task and recovery.
- Conditions
- Borderline Personality Disorder, Oxytocin
- Being tested
- stress test
- Keywords
- cortisol, tsst, borderline personnality, stress
- 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.
stress testOther
TSST- psychosocial stress test
| Study group | Role | What they receive |
|---|---|---|
| Borderline personality disorder | female patients between 18 and 25 years old meeting DSM V criteria for borderline personality disorder Receives: Other: stress test | |
| Control | female participants between 18 and 25 years old, with no psychiatric history, not meeting criteria for borderline personality disorder Receives: Other: stress test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary cortisol
salivary cortisol measured with salivettes (swabs)
Measured: Baseline
Salivary cortisol
salivary cortisol measured with salivettes (swabs)
Measured: Change in one day (circadian cortisol with 6 measures within one day
Salivary cortisol
salivary cortisol measured with salivettes (swabs)
Measured: Change during experimental task (up to 2 hours)
Salivary oxytocin
salivary oxytocin measured with salivettes (swabs)
Measured: Baseline
Salivary oxytocin
salivary oxytocin measured with salivettes (swabs)
Measured: Two measures within one day
Salivary oxytocin
salivary oxytocin measured with salivettes (swabs)
Measured: Change during experimental task (up to 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start1 Mar 2022
- Primary completion30 Mar 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tatiana Aboulafia Brakha, University of Geneva, Switzerland
- Investigators
- Tatiana Aboulafia Brakha, PhD, Principal investigator, Geneva Univeristy hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357521
- Sponsor's protocol ID
- 2002-00067
- Other IDs
- 2002
- Acronym
- OXT-CORT-BPD
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2022
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Data on the Interplay Between Oxytocin and Cortisol During Stress in Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT05357521
- Acronym / sponsor ID
- OXT-CORT-BPD / 2002-00067
- Conditions
- Borderline Personality Disorder, Oxytocin
- Keywords
- cortisol, tsst, borderline personnality, stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 3 May 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.
This study aims to determine the feasibility and preliminary data on the interaction between oxytocin and cortisol during stress in borderline personnality disorder.
Detailed description
The investigators will recruit 50 female patients with borderline personnality disorder and 50 controls with no psychiatric diagnosis, aged between 18 and 25 years old.
salivary cortisol daily curve ( 6 measures during the day) will be measured in participant's naturalistic environnement, together with salivary oxytocin. In addition, salivary oxytocin and cortisol will be measured during a psychosocial stress task and recovery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Borderline personality disorder | – | Other: stress testfemale patients between 18 and 25 years old meeting DSM V criteria for borderline personality disorder |
| Control | – | Other: stress testfemale participants between 18 and 25 years old, with no psychiatric history, not meeting criteria for borderline personality disorder |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants with and without borderline personality disorder
Key inclusion criteria (1 listed)
- Borderline personality disorder-DSM V
Key exclusion criteria (1 listed)
- Schizophrenia
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 |
|---|---|---|
| stress testTSST- psychosocial stress test | Other | Borderline personality disorder, Control |
Primary outcome
Salivary cortisol
Time frame: Baseline
salivary cortisol measured with salivettes (swabs)
Salivary cortisol
Time frame: Change in one day (circadian cortisol with 6 measures within one day
salivary cortisol measured with salivettes (swabs)
Salivary cortisol
Time frame: Change during experimental task (up to 2 hours)
salivary cortisol measured with salivettes (swabs)
Salivary oxytocin
Time frame: Baseline
salivary oxytocin measured with salivettes (swabs)
Salivary oxytocin
Time frame: Two measures within one day
salivary oxytocin measured with salivettes (swabs)
Salivary oxytocin
Time frame: Change during experimental task (up to 2 hours)
salivary oxytocin measured with salivettes (swabs)
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 16 May 2025.
- 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.
Tatiana Aboulafia Brakha, PhD principal investigator
Geneva Univeristy hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Borderline Personality Disorder and Oxytocin, run by University of Geneva, Switzerland at 1 site in Switzerland.
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 1 inclusion and 1 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 16 May 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 Switzerland. 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?
Salivary cortisol (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2025.