Borderline Personality Disorder Clinical Trial
— ADOLIMISOfficial title:
Multimodal Study of the Emotional Regulation and Impulsivity Among Adolescents With Borderline Personality Disorder : Stress Reactivity and Functional Imaging
Verified date | August 2021 |
Source | Institut National de la Santé Et de la Recherche Médicale, France |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Pôle recherche clinique | Paris |
Lead Sponsor | Collaborator |
---|---|
Institut National de la Santé Et de la Recherche Médicale, France |
France,
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 |
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