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Completed

NCT Number: NCT03602521

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

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.

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Key information

Conditions

Female Borderline Personality Disorder Mental Disorders Personality Disorders

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Lapeyronie

Montpellier, 34295, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interpersonal stress

Other

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 outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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..

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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

  15. 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.

  16. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: ROI

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 27, 2018
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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