Emotional Regulation and Impulsivity Among Adolescents with Borderline Personality Disorder (ADOLIMIS)

Institut National de la Santé Et de la Recherche Médicale, France

Status and phase: Active, not recruiting; Phase 2

Conditions: Adolescent Development; Borderline Personality Disorder

Treatments: Biological: salivary collections of amylase and cortisol; Other: Clinical assessment; Other: Structural and Functional MRI; Behavioral: Stress elicitation experiment

Study type: Interventional

Funder types: Other

Identifiers

NCT03209102

C16-58

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 13 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

BPD adolescents

Experimental group

Description:

Adolescents suffering from Borderline Personality Disorder. Clinical assessment, Stress Elicitation Experiment, Structural and Functional MRI, salivary collections of amylase and cortisol

Treatment:

Behavioral: Stress elicitation experiment

Other: Structural and Functional MRI

Other: Clinical assessment

Biological: salivary collections of amylase and cortisol

Healthy controls adolescents

Experimental group

Description:

Healthy controls adolescents. Clinical assessment, Stress Elicitation Experiment, Structural and Functional MRI, salivary collections of amylase and cortisol

Treatment:

Behavioral: Stress elicitation experiment

Other: Structural and Functional MRI

Other: Clinical assessment

Biological: salivary collections of amylase and cortisol