NCT03602521

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 27, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

February 27, 2019

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2023

Completed
Last Updated

December 20, 2023

Status Verified

June 1, 2023

Enrollment Period

4.5 years

First QC Date

July 18, 2018

Last Update Submit

December 19, 2023

Conditions

Keywords

PsychiatrySuicidal BehaviorBorderline Personality DisorderInterpersonal RelationsSocial StressOxytocinNeuropeptide

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

EXPERIMENTAL

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

HC

ACTIVE COMPARATOR

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

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?"

BPDHC

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Study Officials

  • Deborah Ducasse, MD

    Urgence psychiatric lapeyonie Hospital Montpellier

    PRINCIPAL INVESTIGATOR

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

Locations