Reactivity of Patients With Borderline Personality Disorder to an Ecological Interpersonal Stress
ROI
1 other identifier
interventional
116
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2018
CompletedFirst Posted
Study publicly available on registry
July 27, 2018
CompletedStudy Start
First participant enrolled
February 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 18, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 18, 2023
CompletedDecember 20, 2023
June 1, 2023
4.5 years
July 18, 2018
December 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (16)
Evolution of plasma oxytocin concentrations
from pre stress to 40 minutes post 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
self-damaging compelling needs(suicidal) pre stress
pre stress before the interpersonal stress
Evolution of clinical variables: self-damaging compelling needs(suicidal)
from pre stress to 40 minutes post interpersonal stress
- +11 more secondary outcomes
Study Arms (2)
BPD
EXPERIMENTALBlood sample After simulating an interpersonal stress, the evolution of plasma neuropeptides level (OXT, vasopressin and opioid) of patients with a BPD
HC
ACTIVE COMPARATORBlood 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
Interventions
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?"
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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)
- Having reached the maximum annual amount of allowances of € 4,500
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Lapeyronie
Montpellier, 34295, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deborah Ducasse, MD
Urgence psychiatric lapeyonie Hospital Montpellier
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2018
First Posted
July 27, 2018
Study Start
February 27, 2019
Primary Completion
August 18, 2023
Study Completion
August 18, 2023
Last Updated
December 20, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share