NCT05357521

Brief Summary

This study aims to determine the feasibility and preliminary data on the interaction between oxytocin and cortisol during stress in borderline personnality disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

May 16, 2025

Status Verified

March 1, 2024

Enrollment Period

3.1 years

First QC Date

March 5, 2022

Last Update Submit

May 13, 2025

Conditions

Borderline Personality DisorderOxytocin

Keywords

cortisoltsstborderline personnalitystress

Outcome Measures

Primary Outcomes (6)

  • Salivary cortisol

    salivary cortisol measured with salivettes (swabs)

    Baseline

  • Salivary cortisol

    salivary cortisol measured with salivettes (swabs)

    Change in one day (circadian cortisol with 6 measures within one day

  • Salivary cortisol

    salivary cortisol measured with salivettes (swabs)

    Change during experimental task (up to 2 hours)

  • Salivary oxytocin

    salivary oxytocin measured with salivettes (swabs)

    Baseline

  • Salivary oxytocin

    salivary oxytocin measured with salivettes (swabs)

    Two measures within one day

  • Salivary oxytocin

    salivary oxytocin measured with salivettes (swabs)

    Change during experimental task (up to 2 hours)

Study Arms (2)

Borderline personality disorder

female patients between 18 and 25 years old meeting DSM V criteria for borderline personality disorder

Other: stress test

Control

female participants between 18 and 25 years old, with no psychiatric history, not meeting criteria for borderline personality disorder

Other: stress test

Interventions

stress testOTHER

TSST- psychosocial stress test

Borderline personality disorderControl

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants with and without borderline personality disorder

You may qualify if:

  • Borderline personality disorder-DSM V

You may not qualify if:

  • Schizophrenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Young Adult Psychiatric Unit

Geneva, Canton of Geneva, 1202, Switzerland

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Tatiana Aboulafia Brakha, PhD

    Geneva Univeristy hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 5, 2022

First Posted

May 3, 2022

Study Start

March 1, 2022

Primary Completion

March 30, 2025

Study Completion

April 30, 2025

Last Updated

May 16, 2025

Record last verified: 2024-03

Locations

CH(1)