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Active, not recruitingNCT03209102ADOLIMISUpdated Mar 13, 2025

Emotional Regulation and Impulsivity Among Adolescents with Borderline Personality Disorder

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

Phase
Phase 2
Study type
Interventional
Enrollment
66
Allocation
Non-randomized
Ages
13 Years to 18 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Borderline Personality Disorder
  • Adolescent Development
03

Who can participate

Ages eligible
13 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adolescent subject: 13 years ≤ age ≤ 18years
  • Affiliation to social welfare
  • Informed consent to participate in the protocol, consent signed by the major subject or by one of the legal guardians if the subject is a minor
  • Diagnosis of borderline personality disorder according to Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) and Abbreviated- Diagnostic Interview of Borderline Personality Disorder (Ab-DIB)
  • Somatic and intellectual state compatible with blood sampling and MRI examination

Exclusion criteria

Exclusion Criteria:

  • Non-affiliation to social welfare
  • Refusal to give consent and / or to sign informed consent by the subject or his or her legal guardian if the subject is a minor
  • Somatic pathology in progress, or pregnancy (urine test of pregnancy in case of doubt)
  • Contraindication to magnetic resonance imaging:
  • Presence of a ferromagnetic foreign body
  • Subject carrying a pacemaker
  • Subject carrying ventricular bypass valves
  • Claustrophobic topic
  • Subject suffering from the following diseases:
  • Intellectual impairment Intellectual Quotient (IQ) \<70,
  • Claustrophobia,
  • Obsessive Compulsive Disorder,
  • Tic Disorder,
  • Autism Spectrum Disorder,
  • Attention Deficit Disorder with or without Hyperactivity,
  • Bipolar disorder,
  • Schizophrenia
04

Study design

Phase
Phase 2
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
66 participants (estimated)

Study arms

  • Experimental
    BPD adolescents

    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

  • Experimental
    Healthy controls adolescents

    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

Interventions

  • OtherClinical assessment

    * 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

  • BehavioralStress elicitation experiment

    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).

  • OtherStructural and Functional MRI

    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.

  • Biologicalsalivary collections of amylase and cortisol

    Collection of saliva samples of cortisol and amylase repeated three times

05

What researchers measure

Primary outcomes

  1. 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

  2. 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

06

Study locations

1 site
  • Pôle recherche clinique
    Paris, 75013, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03209102
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Responsible party
Sponsor
First posted
Jul 6, 2017
Start date
Oct 4, 2017
Primary completion
Oct 4, 2024
Completion
Jan 3, 2026 (estimated)
Last update
Mar 13, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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