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Trial record 53 of 607 for:    Personality Disorders

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

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ClinicalTrials.gov Identifier: NCT03602521
Recruitment Status : Not yet recruiting
First Posted : July 27, 2018
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.

BPD 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 BPD

Negative interpersonal events (events occurring between two people) are known as the main stressor that trigger a suicidal attempt.

People with a BPD 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 plama 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 feelling will be collected as well.


Condition or disease Intervention/treatment Phase
Female Borderline Personality Disorder Other: Interpersonal stress Not Applicable

Detailed Description:

A dysregulation of the neuropeptides (OXT, vasopressin and opioid) could explain the dysregulation of the emotions of people with BPD.

Up to this date there is no other study measuring neuropeptides kinetics of patient with BPD after an interpersonal stress.

This task of stress is meant to reproduce what people with BPD 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 imediat, 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 stoechiometric concentration in the plasma as copeptine 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 BPD than HC.

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Reactivity of Patients With Borderline Personality Disorder to an Ecological Interpersonal Stress : Pathophysiology of Suicidal Behaviors Study Model
Estimated Study Start Date : July 19, 2018
Estimated Primary Completion Date : July 19, 2018
Estimated Study Completion Date : November 19, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BPD
Blood sample After simulating an interpersonal stress, the evolution of plama neuropeptides level (OXT, vasopressin and opioid) of patients with a BPD
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?"

Active Comparator: HC
Blood sample After simulating an interpersonal stress, the evolution of plama neuropeptides level (OXT, vasopressin and opioid) of healthy controls (HC) patients .without any history of psychopathology
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?"




Primary Outcome Measures :
  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 Outcome Measures :
  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 imediat, 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 imediat, 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 imediat, 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 imediat, 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 imediat 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 imediat, 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 imediat 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 imediat, 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 imediat 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 imediat, 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 imediat 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 imediat, 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 imediat 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 imediat, 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 imediat 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 imediat, 5 minutes, 15 minutes and 40 minutes after an interpersonal stress of patients with BPDs in comparison to healthy controls.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03602521


Contacts
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Contact: Deborah Ducasse, MD +33 4 67 33 85 81 d-ducasse@chu-montpellier.fr

Locations
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France
Hospital Lapeyronie Not yet recruiting
Montpellier, France, 34295
Contact: Catherine GENTY    + 33 4 67 99 61 45 75    c-genty@chu-montpellier.fr   
Contact: Laetitia LACOURT    04 67 33 56 63    laetitialacourt37@gmail.com   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Deborah Ducasse, MD Urgence psychiatric lapeyonie Hospital Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03602521     History of Changes
Other Study ID Numbers: RECHMPL17_0394
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Montpellier:
Psychiatry
Suicidal Behavior
Borderline Personality Disorder
Interpersonal Relations
Social Stress
Oxytocin
Neuropeptide

Additional relevant MeSH terms:
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Disease
Personality Disorders
Borderline Personality Disorder
Pathologic Processes
Mental Disorders