Emotional Regulation and Impulsivity Among Adolescents with Borderline Personality Disorder

Phase 2

Active, not recruiting

• Conditions: Adolescent Development; Borderline Personality Disorder
• Interventions: Other: Clinical assessment; Behavioral: Stress elicitation experiment; Other: Structural and Functional MRI; Biological: salivary collections of amylase and cortisol

• Registration Number: NCT03209102
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Brief 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.

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.

Study Timeline

• Study First Submitted: 2017-06-13
• Study First Submitted QC: 2017-07-03
• Study First Posted: 2017-07-06
• Study Start: 2017-10-04
• Primary Completion: 2024-10-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13
• Study Completion: 2026-01-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy controls adolescents	salivary collections of amylase and cortisol	Healthy controls adolescents. Clinical assessment, Stress Elicitation Experiment, Structural and Functional MRI, salivary collections of amylase and cortisol
BPD adolescents	salivary collections of amylase and cortisol	Adolescents suffering from Borderline Personality Disorder. Clinical assessment, Stress Elicitation Experiment, Structural and Functional MRI, salivary collections of amylase and cortisol
Healthy controls adolescents	Stress elicitation experiment	Healthy controls adolescents. Clinical assessment, Stress Elicitation Experiment, Structural and Functional MRI, salivary collections of amylase and cortisol
BPD adolescents	Clinical assessment	Adolescents suffering from Borderline Personality Disorder. Clinical assessment, Stress Elicitation Experiment, Structural and Functional MRI, salivary collections of amylase and cortisol
BPD adolescents	Stress elicitation experiment	Adolescents suffering from Borderline Personality Disorder. Clinical assessment, Stress Elicitation Experiment, Structural and Functional MRI, salivary collections of amylase and cortisol
BPD adolescents	Structural and Functional MRI	Adolescents suffering from Borderline Personality Disorder. Clinical assessment, Stress Elicitation Experiment, Structural and Functional MRI, salivary collections of amylase and cortisol
Healthy controls adolescents	Clinical assessment	Healthy controls adolescents. Clinical assessment, Stress Elicitation Experiment, Structural and Functional MRI, salivary collections of amylase and cortisol
Healthy controls adolescents	Structural and Functional MRI	Healthy controls adolescents. Clinical assessment, Stress Elicitation Experiment, Structural and Functional MRI, salivary collections of amylase and cortisol

Primary Outcome Measures

Name	Time	Method
Comparison between subjective and objective acute stress experience in BPD Adolescents vs Healthy controls	up to 3 months	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.
Investigating the neural correlates and modulation of motivation and impulsivity using structural and task-based fMRI	up to 3 months	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.

Trial Locations

Locations (1)

Pôle recherche clinique; 🇫🇷 Paris, France