search
Back to results

Reactivity of Patients With Borderline Personality Disorder to an Ecological Interpersonal Stress (ROI)

Primary Purpose

Female, Borderline Personality Disorder

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Interpersonal stress
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Female focused on measuring Psychiatry, Suicidal Behavior, Borderline Personality Disorder, Interpersonal Relations, Social Stress, Oxytocin, Neuropeptide

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

No specific inclusion criteria :

  • If taking hormonal contraceptive: able to participate between the 3rd and 18th day after taking the contraceptive If not taking hormonal contraceptive: able to participate between the 5th and 12th day after the first day of the last period
  • Able to understand the nature, purpose and methodology of the study
  • Having signed the informed consent
  • To be affiliated to a social security scheme

Specific inclusion criteria

Borderline Personality Disorder(BPD) :

- Clinical diagnosis of BPD using the SCID II (Structured Clinical Interview for DSM-IV-TR Axis II Personality Disorders)

Healthy controls:

- No personal history of psychiatric disorders (Axis I ) defined by the MINI International Neuropsychiatric Interview according to the DSM-5 criteria

Exclusion Criteria:

  • Refusal of participation
  • Subject protected by law (guardianship)
  • Life time diagnosis of schizoaffective disorder or schizophrenia
  • Pregnant or breastfeeding women
  • Deprived of liberty Subject (by judicial or administrative decision)
  • Exclusion period in relation to another protocol
  • Having reached the maximum annual amount of allowances of € 4,500

Sites / Locations

  • Hospital LapeyronieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BPD

HC

Arm Description

Blood sample After simulating an interpersonal stress, the evolution of plasma neuropeptides level (OXT, vasopressin and opioid) of patients with a BPD

Blood sample After simulating an interpersonal stress, the evolution of plasma neuropeptides level (OXT, vasopressin and opioid) of healthy controls (HC) patients .without any history of psychopathology

Outcomes

Primary Outcome Measures

Variation of plasma oxytocin concentrations after an interpersonal stress
Evaluate and compare the variation of plasma oxytocin concentrations before and after an interpersonal stress of patients with BPDs vs healthy controls between pre stress to 5 minutes post interpersonal stress.

Secondary Outcome Measures

Evolution of plasma oxytocin concentrations
Evaluate and compare the evolution of plasma oxytocin concentrations before and after an interpersonal stress of patients with BPDs vs healthy controls. pre stress, post stress immediat, 5 minutes post stress, 15 minutes post stress and 40 minutes post stress.
Evolution of plasma copeptin concentrations
Evaluate and compare the evolution of plasma copeptin concentrations before and after an interpersonal stress of patients with BPDs vs healthy controls. pre stress, post stress immediat, 5 minutes post stress, 15 minutes post stress and 40 minutes post stress.
Evolution of plasma β-endorphin concentrations
Evaluate and compare the evolution of plasma β-endorphin concentrations before and after an interpersonal stress of patients with BPDs vs healthy controls. pre stress, post stress immediat, 5 minutes post stress, 15 minutes post stress and 40 minutes post stress.
self-damaging compelling needs(suicidal) pre stress
Basal level of self-damaging compelling needs (suicidal) using a numerical scale (0 = I don't want to kill myself ; 10 = Needs to kill myself maximal imaginable ), before an interpersonal stress.
Evolution of clinical variables: self-damaging compelling needs(suicidal)
Evolution of the self-damaging compelling needs (suicidal) using a numerical scale (0 = I don't want to kill myself ; 10 = Needs to kill myself maximal imaginable ) post stress immediat, 5 minutes, 15 minutes and 40 minutes after an interpersonal stress of patients with BPDs in comparison to healthy controls.
Evolution of clinical variables: self-damaging compelling needs(non-suicidal)
Evolution of the self-damaging compelling needs (suicidal) using a numerical scale (0 = I don't want to kill myself ; 10 = Needs to kill myself maximal imaginable ) post stress immediat, 5 minutes, 15 minutes and 40 minutes after an interpersonal stress of patients with BPDs in comparison to healthy controls..
Clinical variable: self-damaging compelling needs(non-suicidal)
Basal level of self-damaging compelling needs (non-suicidal) using a numerical scale (0 = I don't want to hurt myself ; 10 = Needs to hurt myself maximal imaginable), just before an interpersonal stress.
Evolution of self-damaging compelling needs(non-suicidal)
Evolution of the self-damaging compelling needs (non-suicidal) using a numerical scale (0 = I don't want to hurt myself ; 10 = Needs to hurt myself maximal imaginable) post stress immediat, 5 minutes, 15 minutes and 40 minutes after an interpersonal stress, of patients with BPDs in comparison to healthy controls.
psychological pain
Basal level of psychological pain using a numerical scale (0 =No psychological pain ; 10= Psychological pain maximal imaginable), just before an interpersonal stress.
Evolution of clinical variables: psychological pain
Evolution of psychological pain using a numerical scale (0 =No psychological pain ; 10= Psychological pain maximal imaginable) post stress immediat, 5 minutes, 15 minutes and 40 minutes after an interpersonal stress, of patients with BPDs in comparison to healthy controls.
Clinical variable: state of shame
just before the interpersonal stress Description: Basal level of shame using a numerical scale (0 = No shame ; 10 = Shame maximal imaginable), before an interpersonal stress.
Evolution of clinical variables: state of shame
Evolution of the state of shame using a numerical scale (0 = No shame ; 10 = Shame maximal imaginable), post stress immediat, 5 minutes, 15 minutes and 40 minutes after an interpersonal stress of patients with BPDs in comparison to healthy controls.
Clinical variable: state of anger
Basal level of anger using a numerical scale (0 = No anger ; 10 = Anger maximal imaginable), before an interpersonal stress.
Evolution of clinical variables: state of anger
Evolution of the state of anger using a numerical scale(0 = No anger ; 10 = Anger maximal imaginable), post stress immediat, 5 minutes, 15 minutes and 40 minutes after an interpersonal stress of patients with BPDs in comparison to healthy controls
Clinical variable: state of fear
Basal level of fear using a numerical scale (0 = No fear ; 10 = Fear maximal imaginable), before an interpersonal stress.
Evolution of clinical variables: state of fear
Evolution of the state of fear using a numerical scale (0 = No fear ; 10 = Fear maximal imaginable) post stress immediat, 5 minutes, 15 minutes and 40 minutes after an interpersonal stress of patients with BPDs in comparison to healthy controls.

Full Information

First Posted
July 18, 2018
Last Updated
June 7, 2023
Sponsor
University Hospital, Montpellier
search

1. Study Identification

Unique Protocol Identification Number
NCT03602521
Brief Title
Reactivity of Patients With Borderline Personality Disorder to an Ecological Interpersonal Stress
Acronym
ROI
Official Title
Reactivity of Patients With Borderline Personality Disorder to an Ecological Interpersonal Stress : Pathophysiology of Suicidal Behaviors Study Model
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 27, 2019 (Actual)
Primary Completion Date
May 27, 2024 (Anticipated)
Study Completion Date
November 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Use lay language. According to the World Health Organization 1 death by suicide occurs every 40 seconds, leading suicide prevention to one of the public health priority. BPD (Borderline Personality Disorder) is a common condition affecting 6% of the population. This disorder is characterized by unstable emotions, unstable mood, difficulties with relationship and feer of abandonment. Borderline Personality Disorder is also the psychopathology the most related to suicidal attempts. Indeed, up to 50% of the patients admitted to hospital after a suicide attempt are diagnosis with a Borderline Personality Disorder Negative interpersonal events (events occurring between two people) are known as the main stressor that trigger a suicidal attempt. People with a Borderline Personality Disorder are highly sensitive to it. Moreover, neuropeptides such as oxytocin (OXT), vasopressin and opioid are known to be involved in the regulation of the emotions, especially those linked to relationship. The purpose of this study is to improve knowledge in suicidal behaviors. After simulating an interpersonal stress, the evolution of plasma neuropeptides level (OXT, vasopressin and opioid) of patients with a BPD will be compared to healthy controls (HC). Clinical data reflecting how the participant is feeling will be collected as well.
Detailed Description
A dysregulation of the neuropeptides (OXT, vasopressin and opioid) could explain the dysregulation of the emotions of people with Borderline Personality Disorder. Up to this date there is no other study measuring neuropeptides kinetics of patient with Borderline Personality Disorder after an interpersonal stress. This task of stress is meant to reproduce what people with Borderline Personality Disorder suffer in their everyday life (ecological). To reach this point, an imaginary interpersonal stress will be asked to be reproduced by the participants. Neuropeptides concentrations and clinical data (fear, shame, anger, moral pain, compelling needs (suicidal and non-suicidal)) will be collected at different times (pre stress, post stress immediat, 5 minutes post stress,15 minutes post stress and 40 minutes post stress) As copeptin ( fragment C terminal of the vasopressin) and vasopressin are found in stoichiometric concentration in the plasma as copeptin is more stable than vasopressin, plasma copeptin level will be used to reflect the one of vasopressin. The hypothesis is that both the neuropeptide variation and clinical data before and after the interpersonal stress will be higher for the patient with Borderline Personality Disorder than healthy controls. A correlation between clinical assessments and neuropeptides kinetics is expected. This study will help to identify inter-individual and contextual factors impacting neuropeptide's kinetics

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female, Borderline Personality Disorder
Keywords
Psychiatry, Suicidal Behavior, Borderline Personality Disorder, Interpersonal Relations, Social Stress, Oxytocin, Neuropeptide

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BPD
Arm Type
Experimental
Arm Description
Blood sample After simulating an interpersonal stress, the evolution of plasma neuropeptides level (OXT, vasopressin and opioid) of patients with a BPD
Arm Title
HC
Arm Type
Active Comparator
Arm Description
Blood sample After simulating an interpersonal stress, the evolution of plasma neuropeptides level (OXT, vasopressin and opioid) of healthy controls (HC) patients .without any history of psychopathology
Intervention Type
Other
Intervention Name(s)
Interpersonal stress
Intervention Description
Through an interview the evaluator will make a 1 to 2 pages script, written in first-person and in present tense. It will involve an interpersonal conflict between the participants and the person who once trigger their feeling of abandonment. After reading the script the participants will have to close their eyes and imagine the event as if was happening to them, now, in real time, and think about it during 3 minutes. To evaluate the stress efficiency, the evaluator will ask 2 questions : 1) "from 0 (no distress at all) to 10 (maximal unimaginable distress), to wich point this script bring distress to you?" 2) "from 0 (I can not at all) to 10 (I can completely), to wich point are you able to imagine the scenario in real time, as if you were living it?"
Primary Outcome Measure Information:
Title
Variation of plasma oxytocin concentrations after an interpersonal stress
Description
Evaluate and compare the variation of plasma oxytocin concentrations before and after an interpersonal stress of patients with BPDs vs healthy controls between pre stress to 5 minutes post interpersonal stress.
Time Frame
from pre interpersonal stress to 5 minutes post stress
Secondary Outcome Measure Information:
Title
Evolution of plasma oxytocin concentrations
Description
Evaluate and compare the evolution of plasma oxytocin concentrations before and after an interpersonal stress of patients with BPDs vs healthy controls. pre stress, post stress immediat, 5 minutes post stress, 15 minutes post stress and 40 minutes post stress.
Time Frame
from pre stress to 40 minutes post interpersonal stress
Title
Evolution of plasma copeptin concentrations
Description
Evaluate and compare the evolution of plasma copeptin concentrations before and after an interpersonal stress of patients with BPDs vs healthy controls. pre stress, post stress immediat, 5 minutes post stress, 15 minutes post stress and 40 minutes post stress.
Time Frame
from pre stress to 40 minutes post interpersonal stress
Title
Evolution of plasma β-endorphin concentrations
Description
Evaluate and compare the evolution of plasma β-endorphin concentrations before and after an interpersonal stress of patients with BPDs vs healthy controls. pre stress, post stress immediat, 5 minutes post stress, 15 minutes post stress and 40 minutes post stress.
Time Frame
from pre stress to 40 minutes post interpersonal stress
Title
self-damaging compelling needs(suicidal) pre stress
Description
Basal level of self-damaging compelling needs (suicidal) using a numerical scale (0 = I don't want to kill myself ; 10 = Needs to kill myself maximal imaginable ), before an interpersonal stress.
Time Frame
pre stress before the interpersonal stress
Title
Evolution of clinical variables: self-damaging compelling needs(suicidal)
Description
Evolution of the self-damaging compelling needs (suicidal) using a numerical scale (0 = I don't want to kill myself ; 10 = Needs to kill myself maximal imaginable ) post stress immediat, 5 minutes, 15 minutes and 40 minutes after an interpersonal stress of patients with BPDs in comparison to healthy controls.
Time Frame
from pre stress to 40 minutes post interpersonal stress
Title
Evolution of clinical variables: self-damaging compelling needs(non-suicidal)
Description
Evolution of the self-damaging compelling needs (suicidal) using a numerical scale (0 = I don't want to kill myself ; 10 = Needs to kill myself maximal imaginable ) post stress immediat, 5 minutes, 15 minutes and 40 minutes after an interpersonal stress of patients with BPDs in comparison to healthy controls..
Time Frame
from post stress immediat to 40 minutes just after the interpersonal stress
Title
Clinical variable: self-damaging compelling needs(non-suicidal)
Description
Basal level of self-damaging compelling needs (non-suicidal) using a numerical scale (0 = I don't want to hurt myself ; 10 = Needs to hurt myself maximal imaginable), just before an interpersonal stress.
Time Frame
pre stress before the interpersonal stress
Title
Evolution of self-damaging compelling needs(non-suicidal)
Description
Evolution of the self-damaging compelling needs (non-suicidal) using a numerical scale (0 = I don't want to hurt myself ; 10 = Needs to hurt myself maximal imaginable) post stress immediat, 5 minutes, 15 minutes and 40 minutes after an interpersonal stress, of patients with BPDs in comparison to healthy controls.
Time Frame
from post stress immediat to 40 minutes just after the interpersonal stress
Title
psychological pain
Description
Basal level of psychological pain using a numerical scale (0 =No psychological pain ; 10= Psychological pain maximal imaginable), just before an interpersonal stress.
Time Frame
pre stress just before the interpersonal stress
Title
Evolution of clinical variables: psychological pain
Description
Evolution of psychological pain using a numerical scale (0 =No psychological pain ; 10= Psychological pain maximal imaginable) post stress immediat, 5 minutes, 15 minutes and 40 minutes after an interpersonal stress, of patients with BPDs in comparison to healthy controls.
Time Frame
from post stress immediat to 40 minutes just after the interpersonal stress
Title
Clinical variable: state of shame
Description
just before the interpersonal stress Description: Basal level of shame using a numerical scale (0 = No shame ; 10 = Shame maximal imaginable), before an interpersonal stress.
Time Frame
pre stress just before the interpersonal stress
Title
Evolution of clinical variables: state of shame
Description
Evolution of the state of shame using a numerical scale (0 = No shame ; 10 = Shame maximal imaginable), post stress immediat, 5 minutes, 15 minutes and 40 minutes after an interpersonal stress of patients with BPDs in comparison to healthy controls.
Time Frame
from post stress immediat to 40 minutes just after the interpersonal stress
Title
Clinical variable: state of anger
Description
Basal level of anger using a numerical scale (0 = No anger ; 10 = Anger maximal imaginable), before an interpersonal stress.
Time Frame
pre stress just before the interpersonal stress
Title
Evolution of clinical variables: state of anger
Description
Evolution of the state of anger using a numerical scale(0 = No anger ; 10 = Anger maximal imaginable), post stress immediat, 5 minutes, 15 minutes and 40 minutes after an interpersonal stress of patients with BPDs in comparison to healthy controls
Time Frame
from post stress immediat to 40 minutes just after the interpersonal stress
Title
Clinical variable: state of fear
Description
Basal level of fear using a numerical scale (0 = No fear ; 10 = Fear maximal imaginable), before an interpersonal stress.
Time Frame
pre stress just before the interpersonal stress
Title
Evolution of clinical variables: state of fear
Description
Evolution of the state of fear using a numerical scale (0 = No fear ; 10 = Fear maximal imaginable) post stress immediat, 5 minutes, 15 minutes and 40 minutes after an interpersonal stress of patients with BPDs in comparison to healthy controls.
Time Frame
from post stress immediat to 40 minutes just after the interpersonal stress

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: No specific inclusion criteria : If taking hormonal contraceptive: able to participate between the 3rd and 18th day after taking the contraceptive If not taking hormonal contraceptive: able to participate between the 5th and 12th day after the first day of the last period Able to understand the nature, purpose and methodology of the study Having signed the informed consent To be affiliated to a social security scheme Specific inclusion criteria Borderline Personality Disorder(BPD) : - Clinical diagnosis of BPD using the SCID II (Structured Clinical Interview for DSM-IV-TR Axis II Personality Disorders) Healthy controls: - No personal history of psychiatric disorders (Axis I ) defined by the MINI International Neuropsychiatric Interview according to the DSM-5 criteria Exclusion Criteria: Refusal of participation Subject protected by law (guardianship) Life time diagnosis of schizoaffective disorder or schizophrenia Pregnant or breastfeeding women Deprived of liberty Subject (by judicial or administrative decision) Exclusion period in relation to another protocol Having reached the maximum annual amount of allowances of € 4,500
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah Ducasse, MD
Phone
+33 4 67 33 85 81
Email
d-ducasse@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Ducasse, MD
Organizational Affiliation
Urgence psychiatric lapeyonie Hospital Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Lapeyronie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine GENTY
Phone
+ 33 4 67 99 61 45 75
Email
c-genty@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Laetitia LACOURT
Phone
04 67 33 56 63
Email
laetitialacourt37@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Reactivity of Patients With Borderline Personality Disorder to an Ecological Interpersonal Stress

We'll reach out to this number within 24 hrs