OXT-CORT-BPD: Interplay Between Oxytocin and Cortisol During Stress in Borderline Personality Disorder

• Sponsor: University of Geneva, Switzerland (Other)
• Overall Status: Completed
• CT.gov ID: NCT05357521
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Actual Duration (Months): 2
• Patients Per Site Per Month: 9.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Borderline Personality Disorder; Oxytocin	Other: stress test

Detailed Description

The investigators will recruit 10 female patients with borderline personnality disorder and 10 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 Design

• Study Type: Observational
• Actual Enrollment: 19 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Feasibility and Preliminary Data on the Interplay Between Oxytocin and Cortisol During Stress in Borderline Personality Disorder
• Actual Study Start Date: Mar 1, 2022
• Actual Primary Completion Date: Apr 30, 2022
• Actual Study Completion Date: Apr 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Borderline personality disorder female patients between 18 and 25 years old meeting DSM V criteria for borderline personality disorder	Other: stress test; TSST- psychosocial 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; TSST- psychosocial stress test

Outcome Measures

Primary Outcome Measures

1. Salivary cortisol [Baseline]

   salivary cortisol measured with salivettes (swabs)

2. Salivary cortisol [Change in one day (circadian cortisol with 6 measures within one day]

   salivary cortisol measured with salivettes (swabs)

3. Salivary cortisol [Change during experimental task (up to 2 hours)]

   salivary cortisol measured with salivettes (swabs)

4. Salivary oxytocin [Baseline]

   salivary oxytocin measured with salivettes (swabs)

5. Salivary oxytocin [Two measures within one day]

   salivary oxytocin measured with salivettes (swabs)

6. Salivary oxytocin [Change during experimental task (up to 2 hours)]

   salivary oxytocin measured with salivettes (swabs)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 25 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Borderline personality disorder-DSM V

Exclusion Criteria:

• Schizophrenia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Young Adult Psychiatric Unit	Geneva		Switzerland	1202

Sponsors and Collaborators

• University of Geneva, Switzerland

Investigators

• Principal Investigator: Tatiana Aboulafia Brakha, PhD, Geneva Univeristy hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tatiana Aboulafia Brakha, PhD, University of Geneva, Switzerland
• ClinicalTrials.gov Identifier: NCT05357521
• Other Study ID Numbers: 2002-00067
• First Posted: May 3, 2022
• Last Update Posted: Jun 21, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tatiana Aboulafia Brakha, PhD, University of Geneva, Switzerland: cortisol; tsst; borderline personnality; stress
• Additional relevant MeSH terms: Personality Disorders; Borderline Personality Disorder

Study Results

No Results Posted as of Jun 21, 2022