Emotional Regulation and Impulsivity Among Adolescents With Borderline Personality Disorder

Borderline Personality Disorder Clinical Trial

— ADOLIMIS  

Official title:

Multimodal Study of the Emotional Regulation and Impulsivity Among Adolescents With Borderline Personality Disorder : Stress Reactivity and Functional Imaging

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03209102
• Other study ID #: C16-58
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 4, 2017
• Est. completion date: October 2021

Study information

• Verified date: August 2021
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 66
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Development
• Borderline Personality Disorder
• Impulsive Behavior
• Personality Disorders

Intervention

Other:
• 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

Behavioral:
• 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).

Other:
• 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.

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

Locations

Country	Name	City	State
France	Pôle recherche clinique	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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