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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06045650
Other study ID # 2060971
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2024
Est. completion date September 1, 2025

Study information

Verified date May 2024
Source State University of New York - Upstate Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 92
Est. completion date September 1, 2025
Est. primary completion date August 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Individuals with borderline personality disorder will qualify as cases - controls will be age, gender matched individuals without any psychiatric/mental health concerns Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
baseline serum oxytocin levels
Both cases and controls will be assessed for their baseline serum oxytocin levels
Emotional Sensitivity test
To assess the level of emotional sensitivity in the participant
Neuro-economical game
A game played to assess the trust-index of participants
Childhood Trauma Questionnaire
to assess childhood trauma score
Relationships Questionnaire
to assess attachment type
demographic questionnaire
To obtain basic data on demographics

Locations

Country Name City State
United States SUNY Upstate Medical University Syracuse New York

Sponsors (1)

Lead Sponsor Collaborator
State University of New York - Upstate Medical University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation of Oxytocin levels and trust index Day 1
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