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

Borderline Personality Disorder Clinical Trial

— ROI  

Official title:

Reactivity of Patients With Borderline Personality Disorder to an Ecological Interpersonal Stress : Pathophysiology of Suicidal Behaviors Study Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03602521
• Other study ID #: RECHMPL17_0394
• Status: Completed
• Phase: N/A
• Start date: February 27, 2019
• Est. completion date: August 18, 2023

Study information

• Verified date: June 2023
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: August 18, 2023
• Est. primary completion date: August 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Female
• Personality Disorders

Intervention

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?"

Locations

Country	Name	City	State
France	Hospital Lapeyronie	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	from pre interpersonal stress to 5 minutes post stress
Secondary	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.	from pre stress to 40 minutes post interpersonal stress
Secondary	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.	from pre stress to 40 minutes post interpersonal stress
Secondary	Evolution of plasma ß-endorphin concentrations	Evaluate and compare the evolution of plasma ß-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.	from pre stress to 40 minutes post interpersonal stress
Secondary	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.	pre stress before the interpersonal stress
Secondary	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.	from pre stress to 40 minutes post interpersonal stress
Secondary	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..	from post stress immediat to 40 minutes just after the interpersonal stress
Secondary	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.	pre stress before the interpersonal stress
Secondary	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.	from post stress immediat to 40 minutes just after the interpersonal stress
Secondary	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.	pre stress just before the interpersonal stress
Secondary	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.	from post stress immediat to 40 minutes just after the interpersonal stress
Secondary	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.	pre stress just before the interpersonal stress
Secondary	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.	from post stress immediat to 40 minutes just after the interpersonal stress
Secondary	Clinical variable: state of anger	Basal level of anger using a numerical scale (0 = No anger ; 10 = Anger maximal imaginable), before an interpersonal stress.	pre stress just before the interpersonal stress
Secondary	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	from post stress immediat to 40 minutes just after the interpersonal stress
Secondary	Clinical variable: state of fear	Basal level of fear using a numerical scale (0 = No fear ; 10 = Fear maximal imaginable), before an interpersonal stress.	pre stress just before the interpersonal stress
Secondary	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.	from post stress immediat to 40 minutes just after the interpersonal stress