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

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ClinicalTrials.gov Identifier: NCT03602521

Recruitment Status : Recruiting

First Posted : July 27, 2018

Last Update Posted : December 7, 2021

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Sponsor:

Information provided by (Responsible Party):

University Hospital, Montpellier

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.

Condition or disease	Intervention/treatment	Phase
Female Borderline Personality Disorder	Other: Interpersonal stress	Not Applicable

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	116 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Other
Official Title:	Reactivity of Patients With Borderline Personality Disorder to an Ecological Interpersonal Stress : Pathophysiology of Suicidal Behaviors Study Model
Actual Study Start Date :	February 27, 2019
Estimated Primary Completion Date :	May 27, 2022
Estimated Study Completion Date :	November 27, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Personality Disorders

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: BPD Blood sample After simulating an interpersonal stress, the evolution of plasma neuropeptides level (OXT, vasopressin and opioid) of patients with a BPD	Other: Interpersonal stress 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?"
Active Comparator: HC 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	Other: Interpersonal stress 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?"

Arm

Intervention/treatment

Experimental: BPD

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

Other: Interpersonal stress

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?"

Active Comparator: HC

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

Other: Interpersonal stress

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?"

Outcome Measures

Primary Outcome Measures :

Variation of plasma oxytocin concentrations after an interpersonal stress [ Time Frame: from pre interpersonal stress to 5 minutes post 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 [ Time Frame: from pre stress to 40 minutes post interpersonal stress ]
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 [ Time Frame: from pre stress to 40 minutes post interpersonal stress ]
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 [ Time Frame: from pre stress to 40 minutes post interpersonal stress ]
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 [ Time Frame: pre stress before the interpersonal 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) [ Time Frame: from pre stress to 40 minutes post interpersonal stress ]
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) [ Time Frame: from post stress immediat to 40 minutes just after the interpersonal stress ]
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) [ Time Frame: pre stress before the interpersonal stress ]
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) [ Time Frame: from post stress immediat to 40 minutes just after the interpersonal stress ]
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 [ Time Frame: pre stress just before the interpersonal stress ]
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 [ Time Frame: from post stress immediat to 40 minutes just after the interpersonal stress ]
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 [ Time Frame: pre stress just before the interpersonal stress ]
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 [ Time Frame: from post stress immediat to 40 minutes just after the interpersonal stress ]
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 [ Time Frame: pre stress just before the interpersonal stress ]
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 [ Time Frame: from post stress immediat to 40 minutes just after the interpersonal stress ]
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 [ Time Frame: pre stress just before the interpersonal stress ]
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 [ Time Frame: from post stress immediat to 40 minutes just after the interpersonal stress ]
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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03602521

Contacts

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Contact: Deborah Ducasse, MD	+33 4 67 33 85 81	d-ducasse@chu-montpellier.fr

Locations

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France
Hospital Lapeyronie	Recruiting
Montpellier, France, 34295
Contact: Catherine GENTY + 33 4 67 99 61 45 75 c-genty@chu-montpellier.fr
Contact: Laetitia LACOURT 04 67 33 56 63 laetitialacourt37@gmail.com

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

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Principal Investigator:	Deborah Ducasse, MD	Urgence psychiatric lapeyonie Hospital Montpellier

More Information

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Responsible Party:	University Hospital, Montpellier
ClinicalTrials.gov Identifier:	NCT03602521
Other Study ID Numbers:	RECHMPL17_0394
First Posted:	July 27, 2018 Key Record Dates
Last Update Posted:	December 7, 2021
Last Verified:	December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by University Hospital, Montpellier:


Psychiatry Suicidal Behavior Borderline Personality Disorder Interpersonal Relations	Social Stress Oxytocin Neuropeptide

Additional relevant MeSH terms:

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Disease Personality Disorders Borderline Personality Disorder Pathologic Processes Mental Disorders

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