Clinical trial NCT03209102: Emotional Regulation and Impulsivity Among Adolescents with Borderline Personality Disorder
Official title: Multimodal Study of the Emotional Regulation and Impulsivity Among Adolescents with Borderline Personality Disorder : Stress Reactivity and Functional Imaging
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Borderline Personality Disorder
Adolescent Development
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2017-07-06
Enrollment: 66
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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 outcomes:
measure: Comparison between subjective and objective acute stress experience in BPD Adolescents vs Healthy controls
timeFrame: up to 3 months
measure: Investigating the neural correlates and modulation of motivation and impulsivity using structural and task-based fMRI
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Pôle recherche clinique
Study officials:
References: