NCT06045650

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

May 24, 2024

Status Verified

May 1, 2024

Enrollment Period

1.2 years

First QC Date

September 7, 2023

Last Update Submit

May 22, 2024

Conditions

Keywords

oxytocinborderline personality disordertrust-related behaviorattachment styleschildhood traumaemotional sensitivity

Outcome Measures

Primary Outcomes (1)

  • Correlation of Oxytocin levels and trust index

    Day 1

Study Arms (2)

Cases

Participants with borderline personality disorder who meet the inclusion criteria

Other: baseline serum oxytocin levelsOther: Emotional Sensitivity testOther: Neuro-economical gameOther: Childhood Trauma QuestionnaireOther: Relationships QuestionnaireOther: demographic questionnaire

Controls

Participants without borderline personality disorder, who meet the inclusion criteria

Other: baseline serum oxytocin levelsOther: Emotional Sensitivity testOther: Neuro-economical gameOther: Childhood Trauma QuestionnaireOther: Relationships QuestionnaireOther: demographic questionnaire

Interventions

Both cases and controls will be assessed for their baseline serum oxytocin levels

CasesControls

To assess the level of emotional sensitivity in the participant

CasesControls

A game played to assess the trust-index of participants

CasesControls

to assess childhood trauma score

CasesControls

to assess attachment type

CasesControls

To obtain basic data on demographics

CasesControls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Individuals with borderline personality disorder will qualify as cases
  • controls will be age, gender matched individuals without any psychiatric/mental health concerns

You may not qualify if:

  • for all: pregnancy, hormonal or neurological disorders, and any kind of regular medication
  • for controls: MacLEan screening instrument for BPD will be used at the time of screening to exclude BPD diagnosis in controls

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Borderline Personality DisorderHypersensitivity

Interventions

Childhood Trauma Questionnaire

Condition Hierarchy (Ancestors)

Personality DisordersMental DisordersImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D./PhD, Director of Inpatient Unit, Associate Professor, Department of Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

September 7, 2023

First Posted

September 21, 2023

Study Start

June 1, 2024

Primary Completion

August 1, 2025

Study Completion

September 1, 2025

Last Updated

May 24, 2024

Record last verified: 2024-05

Locations