- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05357521
Interplay Between Oxytocin and Cortisol During Stress in Borderline Personality Disorder (OXT-CORT-BPD)
Feasibility and Preliminary Data on the Interplay Between Oxytocin and Cortisol During Stress in Borderline Personality Disorder
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Geneva, Switzerland, 1202
- Young Adult Psychiatric Unit
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Borderline personality disorder-DSM V
Exclusion Criteria:
- Schizophrenia
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Borderline personality disorder
female patients between 18 and 25 years old meeting DSM V criteria for borderline personality disorder
|
TSST- psychosocial stress test
|
|
Control
female participants between 18 and 25 years old, with no psychiatric history, not meeting criteria for borderline personality disorder
|
TSST- psychosocial stress test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Salivary cortisol
Time Frame: Baseline
|
salivary cortisol measured with salivettes (swabs)
|
Baseline
|
|
Salivary cortisol
Time Frame: Change in one day (circadian cortisol with 6 measures within one day
|
salivary cortisol measured with salivettes (swabs)
|
Change in one day (circadian cortisol with 6 measures within one day
|
|
Salivary cortisol
Time Frame: Change during experimental task (up to 2 hours)
|
salivary cortisol measured with salivettes (swabs)
|
Change during experimental task (up to 2 hours)
|
|
Salivary oxytocin
Time Frame: Baseline
|
salivary oxytocin measured with salivettes (swabs)
|
Baseline
|
|
Salivary oxytocin
Time Frame: Two measures within one day
|
salivary oxytocin measured with salivettes (swabs)
|
Two measures within one day
|
|
Salivary oxytocin
Time Frame: Change during experimental task (up to 2 hours)
|
salivary oxytocin measured with salivettes (swabs)
|
Change during experimental task (up to 2 hours)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Tatiana Aboulafia Brakha, PhD, Geneva Univeristy hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2002-00067
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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