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

Primary Purpose

Borderline Personality Disorder, Adolescent Development

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Clinical assessment
Stress elicitation experiment
Structural and Functional MRI
salivary collections of amylase and cortisol
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Borderline Personality Disorder

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesAccepts 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

Sites / Locations

  • Pôle recherche clinique

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

BPD adolescents

Healthy controls adolescents

Arm Description

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, Stress Elicitation Experiment, Structural and Functional MRI, salivary collections of amylase and cortisol

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 13, 2017
Last Updated
August 25, 2021
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT03209102
Brief Title
Emotional Regulation and Impulsivity Among Adolescents With Borderline Personality Disorder
Acronym
ADOLIMIS
Official Title
Multimodal Study of the Emotional Regulation and Impulsivity Among Adolescents With Borderline Personality Disorder : Stress Reactivity and Functional Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 4, 2017 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder, Adolescent Development

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BPD adolescents
Arm Type
Experimental
Arm Description
Adolescents suffering from Borderline Personality Disorder. Clinical assessment, Stress Elicitation Experiment, Structural and Functional MRI, salivary collections of amylase and cortisol
Arm Title
Healthy controls adolescents
Arm Type
Experimental
Arm Description
Healthy controls adolescents. Clinical assessment, Stress Elicitation Experiment, Structural and Functional MRI, salivary collections of amylase and cortisol
Intervention Type
Other
Intervention Name(s)
Clinical assessment
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Stress elicitation experiment
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Structural and Functional MRI
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
salivary collections of amylase and cortisol
Intervention Description
Collection of saliva samples of cortisol and amylase repeated three times
Primary Outcome Measure Information:
Title
Comparison between subjective and objective acute stress experience in BPD Adolescents vs Healthy controls
Description
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.
Time Frame
up to 3 months
Title
Investigating the neural correlates and modulation of motivation and impulsivity using structural and task-based fMRI
Description
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.
Time Frame
up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Pôle recherche clinique
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Emotional Regulation and Impulsivity Among Adolescents With Borderline Personality Disorder

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