We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03209102
Recruitment Status : Not yet recruiting
First Posted : July 6, 2017
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Adolescent Development Other: Clinical assessment Behavioral: Stress elicitation experiment Other: Structural and Functional MRI Biological: salivary collections of amylase and cortisol Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Multimodal Study of the Emotional Regulation and Impulsivity Among Adolescents With Borderline Personality Disorder : Stress Reactivity and Functional Imaging
Anticipated Study Start Date : July 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: BPD adolescents
Adolescents suffering from Borderline Personality Disorder. Clinical assessment, Stress Elicitation Experiment, Structural and Functional MRI, salivary collections of amylase and cortisol
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
Experimental: Healthy controls adolescents
Healthy controls adolescents. Clinical assessment, Stress Elicitation Experiment, Structural and Functional MRI, salivary collections of amylase and cortisol
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


Outcome Measures

Primary Outcome Measures :
  1. Comparison between subjective and objective acute stress experience in BPD Adolescents vs Healthy controls [ Time Frame: up to 3 months ]
    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.

  2. Investigating the neural correlates and modulation of motivation and impulsivity using structural and task-based fMRI [ Time Frame: up to 3 months ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
More Information

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT03209102     History of Changes
Other Study ID Numbers: C16-58
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Disease
Personality Disorders
Borderline Personality Disorder
Impulsive Behavior
Pathologic Processes
Mental Disorders
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Anti-Inflammatory Agents