FemaleROINCT03602521
Reactivity of Patients With Borderline Personality Disorder to an Ecological Interpersonal Stress
A study testing Interpersonal stress in people with Female and Borderline Personality Disorder, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female, Borderline Personality Disorder
- What is being tested?
- Interpersonal stress
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2019to 18 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reactivity of Patients With Borderline Personality Disorder to an Ecological Interpersonal Stress : Pathophysiology of Suicidal Behaviors Study Model
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.
Read more
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.
Read the 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)
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
- Conditions
- Female, Borderline Personality Disorder
- Being tested
- Interpersonal stress
- Keywords
- Psychiatry, Suicidal Behavior, Borderline Personality Disorder, Interpersonal Relations, Social Stress, Oxytocin, Neuropeptide
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal stressOther
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?"
| Study group | Role | What they receive |
|---|---|---|
| BPD | Experimental | Blood sample After simulating an interpersonal stress, the evolution of plasma neuropeptides level (OXT, vasopressin and opioid) of patients with a BPD Receives: 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 Receives: Other: Interpersonal stress |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from pre interpersonal stress to 5 minutes post stress
Secondary outcomes (16)
Evolution of plasma oxytocin concentrations
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.
Measured: from pre stress to 40 minutes post interpersonal stress
Evolution of plasma copeptin concentrations
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.
Measured: from pre stress to 40 minutes post interpersonal stress
Evolution of plasma β-endorphin concentrations
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.
Measured: from pre stress to 40 minutes post interpersonal stress
self-damaging compelling needs(suicidal) pre 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.
Measured: pre stress before the interpersonal stress
Evolution of clinical variables: self-damaging compelling needs(suicidal)
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.
Measured: from pre stress to 40 minutes post interpersonal stress
Evolution of clinical variables: self-damaging compelling needs(non-suicidal)
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..
Measured: from post stress immediat to 40 minutes just after the interpersonal stress
Clinical variable: self-damaging compelling needs(non-suicidal)
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.
Measured: pre stress before the interpersonal stress
Evolution of self-damaging compelling needs(non-suicidal)
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.
Measured: from post stress immediat to 40 minutes just after the interpersonal stress
psychological pain
Basal level of psychological pain using a numerical scale (0 =No psychological pain ; 10= Psychological pain maximal imaginable), just before an interpersonal stress.
Measured: pre stress just before the interpersonal stress
Evolution of clinical variables: psychological pain
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.
Measured: from post stress immediat to 40 minutes just after the interpersonal stress
Clinical variable: state of shame
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.
Measured: pre stress just before the interpersonal stress
Evolution of clinical variables: state of shame
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.
Measured: from post stress immediat to 40 minutes just after the interpersonal stress
Clinical variable: state of anger
Basal level of anger using a numerical scale (0 = No anger ; 10 = Anger maximal imaginable), before an interpersonal stress.
Measured: pre stress just before the interpersonal stress
Evolution of clinical variables: state of anger
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
Measured: from post stress immediat to 40 minutes just after the interpersonal stress
Clinical variable: state of fear
Basal level of fear using a numerical scale (0 = No fear ; 10 = Fear maximal imaginable), before an interpersonal stress.
Measured: pre stress just before the interpersonal stress
Evolution of clinical variables: state of fear
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.
Measured: from post stress immediat to 40 minutes just after the interpersonal stress
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start27 Feb 2019
- Primary completion18 Aug 2023
- Study completion18 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FemaleStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah Ducasse, MD, Principal investigator, Urgence psychiatric lapeyonie Hospital Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602521
- Sponsor's protocol ID
- RECHMPL17_0394
- Acronym
- ROI
- Status last verified
- Jun 2023
- First submitted
- 18 Jul 2018
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reactivity of Patients With Borderline Personality Disorder to an Ecological Interpersonal Stress : Pathophysiology of Suicidal Behaviors Study Model
- ClinicalTrials.gov ID
- NCT03602521
- Acronym / sponsor ID
- ROI / RECHMPL17_0394
- Conditions
- Female, Borderline Personality Disorder
- Keywords
- Psychiatry, Suicidal Behavior, Borderline Personality Disorder, Interpersonal Relations, Social Stress, Oxytocin, Neuropeptide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 18 Aug 2023 (actual)
- Study completion
- 18 Aug 2023 (actual)
- First posted
- 27 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPD | Experimental | Other: Interpersonal stressBlood sample After simulating an interpersonal stress, the evolution of plasma neuropeptides level (OXT, vasopressin and opioid) of patients with a BPD |
| HC | Active comparator | Other: Interpersonal stressBlood 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interpersonal stressThrough 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?" | Other | BPD, HC |
Primary outcome
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.
16 secondary outcomes
Evolution of plasma oxytocin concentrations
Time frame: from pre stress to 40 minutes post interpersonal stress
Evolution of plasma copeptin concentrations
Time frame: from pre stress to 40 minutes post interpersonal stress
Evolution of plasma β-endorphin concentrations
Time frame: from pre stress to 40 minutes post interpersonal stress
self-damaging compelling needs(suicidal) pre stress
Time frame: pre stress before the interpersonal stress
Evolution of clinical variables: self-damaging compelling needs(suicidal)
Time frame: from pre stress to 40 minutes post interpersonal stress
Evolution of clinical variables: self-damaging compelling needs(non-suicidal)
Time frame: from post stress immediat to 40 minutes just after the interpersonal stress
Clinical variable: self-damaging compelling needs(non-suicidal)
Time frame: pre stress before the interpersonal stress
Evolution of self-damaging compelling needs(non-suicidal)
Time frame: from post stress immediat to 40 minutes just after the interpersonal stress
psychological pain
Time frame: pre stress just before the interpersonal stress
Evolution of clinical variables: psychological pain
Time frame: from post stress immediat to 40 minutes just after the interpersonal stress
Clinical variable: state of shame
Time frame: pre stress just before the interpersonal stress
Evolution of clinical variables: state of shame
Time frame: from post stress immediat to 40 minutes just after the interpersonal stress
Clinical variable: state of anger
Time frame: pre stress just before the interpersonal stress
Evolution of clinical variables: state of anger
Time frame: from post stress immediat to 40 minutes just after the interpersonal stress
Clinical variable: state of fear
Time frame: pre stress just before the interpersonal stress
Evolution of clinical variables: state of fear
Time frame: from post stress immediat to 40 minutes just after the interpersonal stress
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Ducasse, MD principal investigator
Urgence psychiatric lapeyonie Hospital Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal stress in people with Female and Borderline Personality Disorder, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of plasma oxytocin concentrations after an interpersonal stress (time frame: from pre interpersonal stress to 5 minutes post stress). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.