Borderline Personality DisorderNCT06045650
Relationship Between Oxytocin Level, Trust, and Attachment in Individuals With Borderline Personality Disorder
An observational study of Borderline Personality Disorder, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
We aim to assess the baseline oxytocin levels in individuals with borderline personality disorder and correlate those levels with social behavior, and compare the results with controls. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- baseline serum oxytocin levels, Emotional Sensitivity test and Neuro-economical game
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to 1 Sep 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: cases: individuals who are admitted to the inpatient psychiatry unit at a university hospital controls: healthy volunteers who volunteer to participate from the same city as the university hospital
Who may be able to join
- Individuals with borderline personality disorder will qualify as cases
- controls will be age, gender matched individuals without any psychiatric/mental health concerns
Who cannot join
- for all: pregnancy, hormonal or neurological disorders, and any kind of regular medication
- additional exclusion criteria for cases: a lifetime diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or significant neurological disease, current alcohol/ drug dependence
- for controls: MacLEan screening instrument for BPD will be used at the time of screening to exclude BPD diagnosis in controls
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
Maliha Ansari, MBBS, 551-325-9005, ansarima@upstate.edu
About this study
We aim to assess the baseline oxytocin levels in individuals with borderline personality disorder and correlate those levels with social behavior, and compare the results with controls.
Primary Hypothesis (H1):
Read more
There is a significant difference in trust-related behavior as measured by oxytocin (OXT) levels between borderline personality disorder (BPD) patients and healthy controls.
Secondary Hypotheses:
H2: The trust-related behavior in BPD patients is significantly influenced by their level of emotional sensitivity. Specifically, higher emotional sensitivity in BPD patients is associated with lower trust-related behavior and vice-versa.
H3: There is a significant correlation between trust-related behavior and childhood trauma in BPD patients. BPD patients with higher levels of reported childhood trauma will exhibit lower trust-related behavior compared to those with lower levels of trauma.
H4: Trust-related behavior in BPD patients varies depending on their attachment styles. Specifically, BPD patients with insecure attachment styles will exhibit lower trust-related behavior compared to those with secure attachment styles.
H5: There is a significant correlation between trust-related behavior and BPD severity. Patients with more severe BPD symptoms will exhibit lower trust-related behavior compared to those with less severe symptoms.
H6: The levels of OXT in BPD patients will significantly correlate with their reported levels of emotional sensitivity, childhood trauma, attachment styles, and BPD severity.
These hypotheses aim to address the complexities surrounding the modulation of trust-related behavior by oxytocin in BPD patients, taking into account various factors like emotional sensitivity, childhood adversity, attachment styles, and BPD severity. By testing these hypotheses, the study aims to provide a comprehensive understanding of the interplay between these factors in influencing trust-related behavior in BPD patients.
- Conditions
- Borderline Personality Disorder
- Being tested
- baseline serum oxytocin levels, Emotional Sensitivity test, Neuro-economical game, Childhood Trauma Questionnaire, Relationships Questionnaire
- Keywords
- oxytocin, borderline personality disorder, trust-related behavior, attachment styles, childhood trauma, emotional sensitivity
- Medical subject headings
- Borderline Personality Disorder, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
baseline serum oxytocin levelsOther
Both cases and controls will be assessed for their baseline serum oxytocin levels
Emotional Sensitivity testOther
To assess the level of emotional sensitivity in the participant
Neuro-economical gameOther
A game played to assess the trust-index of participants
Childhood Trauma QuestionnaireOther
to assess childhood trauma score
Relationships QuestionnaireOther
to assess attachment type
demographic questionnaireOther
To obtain basic data on demographics
| Study group | Role | What they receive |
|---|---|---|
| Cases | Participants with borderline personality disorder who meet the inclusion criteria Receives: Other: baseline serum oxytocin levels; Other: Emotional Sensitivity test; Other: Neuro-economical game; Other: Childhood Trauma Questionnaire; Other: Relationships Questionnaire; Other: demographic questionnaire | |
| Controls | Participants without borderline personality disorder, who meet the inclusion criteria Receives: Other: baseline serum oxytocin levels; Other: Emotional Sensitivity test; Other: Neuro-economical game; Other: Childhood Trauma Questionnaire; Other: Relationships Questionnaire; Other: demographic questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of Oxytocin levels and trust index
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Jun 2024 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
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
- Cross-sectional
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luba Leontieva, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045650
- Sponsor's protocol ID
- 2060971
- Status last verified
- May 2024
- First submitted
- 7 Sep 2023
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Oxytocin Level, Trust, and Attachment in Individuals With Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT06045650
- Acronym / sponsor ID
- 2060971
- Conditions
- Borderline Personality Disorder
- Keywords
- oxytocin, borderline personality disorder, trust-related behavior, attachment styles, childhood trauma, emotional sensitivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 21 Sep 2023 (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.
We aim to assess the baseline oxytocin levels in individuals with borderline personality disorder and correlate those levels with social behavior, and compare the results with controls.
Primary Hypothesis (H1):
There is a significant difference in trust-related behavior as measured by oxytocin (OXT) levels between borderline personality disorder (BPD) patients and healthy controls.
Secondary Hypotheses:
H2: The trust-related behavior in BPD patients is significantly influenced by their level of emotional sensitivity. Specifically, higher emotional sensitivity in BPD patients is associated with lower trust-related behavior and vice-versa.
H3: There is a significant correlation between trust-related behavior and childhood trauma in BPD patients. BPD patients with higher levels of reported childhood trauma will exhibit lower trust-related behavior compared to those with lower levels of trauma.
H4: Trust-related behavior in BPD patients varies depending on their attachment styles. Specifically, BPD patients with insecure attachment styles will exhibit lower trust-related behavior compared to those with secure attachment styles.
H5: There is a significant correlation between trust-related behavior and BPD severity. Patients with more severe BPD symptoms will exhibit lower trust-related behavior compared to those with less severe symptoms.
H6: The levels of OXT in BPD patients will significantly correlate with their reported levels of emotional sensitivity, childhood trauma, attachment styles, and BPD severity.
These hypotheses aim to address the complexities surrounding the modulation of trust-related behavior by oxytocin in BPD patients, taking into account various factors like emotional sensitivity, childhood adversity, attachment styles, and BPD severity. By testing these hypotheses, the study aims to provide a comprehensive understanding of the interplay between these factors in influencing trust-related behavior in BPD patients.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: baseline serum oxytocin levels, Other: Emotional Sensitivity test, Other: Neuro-economical game, Other: Childhood Trauma Questionnaire, Other: Relationships Questionnaire, Other: demographic questionnaireParticipants with borderline personality disorder who meet the inclusion criteria |
| Controls | – | Other: baseline serum oxytocin levels, Other: Emotional Sensitivity test, Other: Neuro-economical game, Other: Childhood Trauma Questionnaire, Other: Relationships Questionnaire, Other: demographic questionnaireParticipants without borderline personality disorder, who meet the inclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- cases: individuals who are admitted to the inpatient psychiatry unit at a university hospital controls: healthy volunteers who volunteer to participate from the same city as the university hospital
Key inclusion criteria (2 listed)
- Individuals with borderline personality disorder will qualify as cases
- controls will be age, gender matched individuals without any psychiatric/mental health concerns
Key exclusion criteria (3 listed)
- for all: pregnancy, hormonal or neurological disorders, and any kind of regular medication
- additional exclusion criteria for cases: a lifetime diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or significant neurological disease, current alcohol/ drug dependence
- for controls: MacLEan screening instrument for BPD will be used at the time of screening to exclude BPD diagnosis in controls
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 |
|---|---|---|
| baseline serum oxytocin levelsBoth cases and controls will be assessed for their baseline serum oxytocin levels | Other | Cases, Controls |
| Emotional Sensitivity testTo assess the level of emotional sensitivity in the participant | Other | Cases, Controls |
| Neuro-economical gameA game played to assess the trust-index of participants | Other | Cases, Controls |
| Childhood Trauma Questionnaireto assess childhood trauma score | Other | Cases, Controls |
| Relationships Questionnaireto assess attachment type | Other | Cases, Controls |
| demographic questionnaireTo obtain basic data on demographics | Other | Cases, Controls |
Primary outcome
Correlation of Oxytocin levels and trust index
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- 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.
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, run by State University of New York - Upstate Medical University at 1 site in United States.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 May 2024. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of Oxytocin levels and trust index (time frame: Day 1). 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 24 May 2024.