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Clinical Trials in France / NCT03209102
Active, not recruiting Phase 2

Emotional Regulation and Impulsivity Among Adolescents with Borderline Personality Disorder

NCT03209102 · tracked via the Priya Life Science France tracker
Phase
Phase 2
Started
2017-10-04
Last updated
2025-03-13

Condition(s) studied

Borderline Personality DisorderAdolescent Development

Investigational drug(s) / intervention(s)

Clinical assessmentStress elicitation experimentStructural and Functional MRIsalivary collections of amylase and cortisol

Clinical 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

Stress 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).

Structural 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.

salivary collections of amylase and cortisol: Collection of saliva samples of cortisol and amylase repeated three times

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.

Eligibility

Sex
ALL
Min age
13 Years
Max age
18 Years
Healthy volunteers
Accepted
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: * 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Pôle recherche clinique Paris France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03209102 on ClinicalTrials.gov ↗ ← All trials in France