A Phase 2 interventional study of Clinical assessment and Stress elicitation experiment in Borderline Personality Disorder and Adolescent Development, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Active, not recruiting at 1 site in France. Open to participants aged 13 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-13.
Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Phase 2, Interventional, and Basic science
Among 32 studies in Borderline Personality Disorder with a site in France — 13 open to participants now, 14 under way, none of them phase 3. Borderline Personality Disorder · France.
Among the 32 studies in Borderline Personality Disorder with a site in France, this one is the 14th largest by planned enrollment of the 24 interventional ones that give a count, is one of 2 that started in 2017, is one of 3 in phase 2, reaches primary completion later than 0 of the 13 other live ones, and was the 8th registered.
278 studies on the registry are indexed under Borderline Personality Disorder; 70 are open to participants now.
Browse Borderline Personality Disorder studies →13 of the 32 studies in Borderline Personality Disorder with a site in France are open now. Recruiting first, the newest first:
University Hospital, Montpellier · Sites in France
Ages 18–45 · Healthy volunteers
University Hospital, Strasbourg, France · Sites in France
Ages 12–18
University Hospital, Strasbourg, France · Sites in France
Ages 18–60 · Healthy volunteers
AddiPsy · Sites in France
Ages 18+
Etablissement Public de la Sante Mentale de la Somme · Sites in France
Ages 12–17 · Women only · Healthy volunteers
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 49 Borderline Personality Disorder studies recruiting now, 18 (37%) set no upper age limit and 30 (61%) stop at 75 or younger; 8 take children under 18; 11 take healthy volunteers.
This study: 13 Years to 18 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
32 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 66 is close to the median of 70 across 221 interventional studies indexed under Borderline Personality Disorder.
Median enrollment 72 across the 24 interventional studies, 99 across the 8 observational. Of the 12 that completed or were terminated, 1 (8%) have results posted.
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2 of 32 have an industry lead sponsor. The 10 most frequent:
Institut National de la Santé Et de la Recherche Médicale, France is the lead sponsor of 378 studies on the registry; 81 are open to participants now.
Institut National de la Santé Et de la Recherche Médicale, France has 1 study filed under Borderline Personality Disorder — fewer than ten, so there is no comparison to draw.
2 of the studies in Borderline Personality Disorder with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07540429Etablissement Public de la Sante Mentale de la SommeADOLESCENTS IMAGING USING fMRI: Feasibility Study | 2027-06-08 |
| NCT07794332University Hospital, Strasbourg, FranceSymptom Assessment in Adolescents Placed on Child Welfare | 2027-09-01 |
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Among the 32 studies in Borderline Personality Disorder with a site in France, from their registry updates:
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This study aims to better understand the behavioral, neurobiological and hormonal underpinnings of stress and reward reactivity of adolescents suffering from borderline personality disorder compared to healthy adolescents by a multimodal approach based on clinical assessments, structural and functional mri and experimental acute stress exposure.
Borderline Personality Disorder (BPD) is a severe condition associated with intense emotional and behavioral responses to stressful events, impulsivity, and risk-taking behavior. It has been shown to begin in adolescence. However, very few studies have addressed the physiopathology of BPD in adolescents. In order to gather rational information for targeted care, the heterogeneity of BPD determinants needs to be disentangled. To this aim, a multimodal approach to BPD dimensional aspects is proposed.
BPD adolescents will be compared to typically developing controls in two complementary experimental designs: (1) Monitoring of neurovegetative, hormonal and body motion responses to an acute stress, with the hypothesis that stress reactivity might account for the physiopathology of the disorder; (2) Structural and functional imaging (fMRI BOLD) in the context of a reward processing task to delineate the neural/functional basis of BPD risk taking behavior.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adolescents suffering from Borderline Personality Disorder. Clinical assessment, Stress Elicitation Experiment, Structural and Functional MRI, salivary collections of amylase and cortisol
Other: Clinical assessment · Behavioral: Stress elicitation experiment · Other: Structural and Functional MRI · Biological: salivary collections of amylase and cortisol
Healthy controls adolescents. Clinical assessment, Stress Elicitation Experiment, Structural and Functional MRI, salivary collections of amylase and cortisol
Other: Clinical assessment · Behavioral: Stress elicitation experiment · Other: Structural and Functional MRI · Biological: salivary collections of amylase and cortisol
* Self-assessments based on questionnaires : Strengths and Difficulties Questionnaire - Development and Well-Being Assessment (SDQ-DAWBA) ; Pubertal Development Scale ; Life Events Questionnaire ; Childhood Trauma Questionnaire ; Abbreviated - Diagnostic Instrument for Borderline (Ab-DIB) ; Beck Depression Inventory ; Socio-demographic questionnaire) * and clinical evaluation by a psychiatrist : Mini-International Neuropsychiatric Interview (MINI); Global Assessment of Functioning
The stress elicitation experiment is based on a time-constrained mental arithmetic test in the presence of an observer. The task usually lasts about 30 minutes. During the task, the investigators will monitor: neuro-vegetative parameters (skin conductance, temperature, respiratory and cardiac frequencies, and VNA) ; biological parameters : salivary Cortisol and Amylase before test (baseline), 15 min and 30 min after testing (respectively corresponding to Reactivity and Recovery) ; micro-behavioral cues extracted from 2D video and 3D sensors (Microsoft Kinect).
Structural and Functional Magnetic Resonance Imaging (MRI). The functional acquisition will last 20 minutes and the structural acquisition 18 minutes. All MR image acquisition methodologies are already functioning on the 3 Tesla Prisma machine within the ICM(Brain and Spine Institute), Salpetriere. The fMRI session will provide three types of data: (1) task-related activity to probe the striato-limbic and prefrontal regions, (2) resting state connectivity to examine the integrity of canonical networks, and (3) MR structural images to measure regional volumes of key functional nodes. For the task-related fMRI study, the investigators will use the monetary incentive delay task that reliably elicit an activation in known functional networks underlying reward anticipation/outcome.
Collection of saliva samples of cortisol and amylase repeated three times
Comparison between subjective and objective acute stress experience in BPD Adolescents vs Healthy controls
Comparing subjective (by self-assessment) and objective response to acute stress by measuring the biological (stress hormones and enzymes) and neurovegetative responses to stress and assessing the motor responses to stress by using novel approaches based on specific machine learning algorithms.
Time frame: up to 3 months
Investigating the neural correlates and modulation of motivation and impulsivity using structural and task-based fMRI
The fMRI session will provide three types of data: (1) task-related activity to probe the striato-limbic and prefrontal regions, (2) resting state connectivity to examine the integrity of canonical networks, and (3) MR structural images to measure regional volumes of key functional nodes. For the task-related fMRI study, the investigators will use the monetary incentive delay task that reliably elicit an activation in known functional networks underlying reward anticipation/outcome.
Time frame: up to 3 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in Oct 2024, 84 months.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Borderline Personality Disorder →
Institut National de la Santé Et de la Recherche Médicale, France →