Emotional Regulation and Impulsivity Among Adolescents with Borderline Personality Disorder

NCT03209102 | Active Not Recruiting Phase 2

• 1 other identifier: C16-58
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Borderline Personality Disorder; Adolescent Development

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  up to 3 months

Study Arms (2)

BPD adolescents

EXPERIMENTAL

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

EXPERIMENTAL

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

Clinical assessment OTHER

* 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

BPD adolescents; Healthy controls adolescents

Stress elicitation experiment BEHAVIORAL

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).

BPD adolescents; Healthy controls adolescents

Structural and Functional MRI OTHER

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.

BPD adolescents; Healthy controls adolescents

salivary collections of amylase and cortisol BIOLOGICAL

Collection of saliva samples of cortisol and amylase repeated three times

BPD adolescents; Healthy controls adolescents

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Pôle recherche clinique

Paris, 75013, France

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: July 6, 2017
• Study Start: October 4, 2017
• Primary Completion: October 4, 2024
• Study Completion: January 3, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)