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Clinical Trials/NCT03602521
NCT03602521CompletedNot Applicable

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

University Hospital, Montpellier2 sites in 1 country116 target enrollmentStarted: February 27, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
116
Locations
2
Primary Endpoint
Variation of plasma oxytocin concentrations after an interpersonal stress

Study Overview

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)

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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

  • Clinical variable: self-damaging compelling needs(non-suicidal)(pre stress before the interpersonal stress)
  • Clinical variable: state of shame(pre stress just before the interpersonal stress)
  • Evolution of plasma copeptin concentrations(from pre stress to 40 minutes post interpersonal stress)
  • Evolution of plasma β-endorphin concentrations(from pre stress to 40 minutes post interpersonal stress)
  • Evolution of clinical variables: self-damaging compelling needs(suicidal)(from pre stress to 40 minutes post interpersonal stress)
  • Evolution of clinical variables: self-damaging compelling needs(non-suicidal)(from post stress immediat to 40 minutes just after the interpersonal stress)
  • Evolution of self-damaging compelling needs(non-suicidal)(from post stress immediat to 40 minutes just after the interpersonal stress)
  • Evolution of plasma oxytocin concentrations(from pre stress to 40 minutes post interpersonal stress)
  • Evolution of clinical variables: state of shame(from post stress immediat to 40 minutes just after the interpersonal stress)
  • Evolution of clinical variables: state of fear(from post stress immediat to 40 minutes just after the interpersonal stress)
  • self-damaging compelling needs(suicidal) pre stress(pre stress before the interpersonal stress)
  • Evolution of clinical variables: psychological pain(from post stress immediat to 40 minutes just after the interpersonal stress)
  • Clinical variable: state of anger(pre stress just before the interpersonal stress)
  • psychological pain(pre stress just before the interpersonal stress)
  • Evolution of clinical variables: state of anger(from post stress immediat to 40 minutes just after the interpersonal stress)
  • Clinical variable: state of fear(pre stress just before the interpersonal stress)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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