NCT04852744

Brief Summary

Borderline personality disorder (BPD) is a common mental disorder in adolescents with significant individual and societal repercussions, characterized over the long term by emotional hyperresponsiveness, relational instability, identity disturbances and self-aggressive behavior. The etiology of BPD is multifactorial and involves exposure to traumatic life events, which are present in the majority of cases. This explains the very common co-morbidity between BPD and post-traumatic stress disorder (PTSD), which involves emotionally painful memory relapses of one or more traumatic events, associated with an emotional trauma avoidance syndrome (s). ) and hypervigilance. Brain imaging studies in adolescents with BPD have shown decreases in the volume of gray matter within the frontolimbic network, as well as a decrease in frontolimbic white matter bundles. These brain changes are considered to be biological markers of TPB. However, the exact same brain changes are seen in PTSD. Although it represents more than a third of adolescents hospitalized in psychiatry, neuroscientific studies of BPD in adolescence are still scarce. The expertise we have acquired in U1077 in adolescents with PTSD offers us an exceptional opportunity to characterize in BPD with and without PTSD structural anomalies, including the hippocampus, and functional at rest, never used for hour in the teenager's BPD. Beyond that, carrying out an 18-month follow-up of the patients will allow us to assess the predictive value of these anomalies on the level of general psychopathology in all the patients studied and the intensity of the symptoms of traumatic relapse in the patients with PTSD. This modeling of disorders integrating psychopathological, neuropsychological and neuroanatomical approaches will provide the clinician with new knowledge necessary for therapeutic innovation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
25mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Mar 2022Jun 2028

First Submitted

Initial submission to the registry

April 16, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
11 months until next milestone

Study Start

First participant enrolled

March 11, 2022

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

July 25, 2025

Status Verified

July 1, 2025

Enrollment Period

5.7 years

First QC Date

April 16, 2021

Last Update Submit

July 22, 2025

Conditions

Keywords

AdolescenceHippocampusNeuropsychologyBorderline personality disorderPost-traumatic stress disorder

Outcome Measures

Primary Outcomes (1)

  • Hippocampal volume

    during the month following inclusion

Study Arms (3)

Borderline girls with PTSD

OTHER

* female * Age between 13 and 17 years inclusive * Diagnosis of borderline personality disorder according to the criteria of the Diagnostic and Statistical Manual for mental disorders, fifth edition (DSM-5; American Psychiatric Association, 2013; SIDP-IV) * Post-traumatic stress disorder according to DSM-5 criteria (American Psychiatric Association, 2013; K-SADS-PL) * Level of general psychopathology compatible with participation in the study (score\> 20 on the CGA-S) * Oral and written comprehension of the French language * Affiliation to the social security scheme * Informed consent signed by the legal representatives holding the exercise of parental authority and the adolescent herself

Other: Brain MRI

Borderline girls without PTSD

OTHER

* female * Age between 13 and 17 years inclusive * Diagnosis of borderline personality disorder according to the criteria of the Diagnostic and Statistical Manual for mental disorders, fifth edition (DSM-5; American Psychiatric Association, 2013; SIDP-IV) * Level of general psychopathology compatible with participation in the study (score\> 20 on the CGA-S) * Oral and written comprehension of the French language * Affiliation to the social security scheme * Informed consent signed by the legal representatives holding the exercise of parental authority and the adolescent herself

Other: Brain MRI

Healthy controls

OTHER

* female * Age between 13 and 17 years inclusive * Absence of mental disorder according to DSM-5 (American Psychiatric Association, 2013 ; K-SADS-PL et SIDP-IV) * Oral and written comprehension of the French language * Affiliation to the social security scheme * Informed consent signed by the legal representatives holding the exercise of parental authority and the adolescent herself

Other: Brain MRI

Interventions

Anatomical MRI The anatomical data will be acquired by means of a 3T Signa Premier General Electric Healthcare MRI, allowing the acquisition of classic anatomical sequences (T1, T2) and a high-resolution hippocampal sequence allowing to accurately apprehend its various sub-fields. (total acquisition time: 10 min). The hippocampal volume, the orbital-frontal cortex and the cingulate cortex will be measured by voxel-based morphometry (VBM; Ashburner \& Friston, 2000\]) using the SPM software (Statistical Parametric Mapping; Friston et al., 2006). The voxel-by-voxel morphometric analysis of T1 MRI images makes it possible to classify and segment the different brain tissues (gray matter versus white matter) and to analyze the focal differences in volume within these tissues between the different groups.

Also known as: Psychological and behavioural assessment
Borderline girls with PTSDBorderline girls without PTSDHealthy controls

Eligibility Criteria

Age13 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • For the 3 groups:
  • female
  • Age between 13 and 17 years inclusive
  • Oral and written comprehension of the French language
  • Affiliation to the social security scheme
  • Informed consent signed by the legal representatives holding the exercise of parental authority and the adolescent herself
  • For patients:
  • Diagnosis of borderline personality disorder according to the criteria of the Diagnostic and Statistical Manual for mental disorders, fifth edition (DSM-5; American Psychiatric Association, 2013; SIDP-IV)
  • Level of general psychopathology compatible with participation in the study (score\> 20 on the CGA-S)
  • TB + / PTSD + group:
  • \- Post-traumatic stress disorder according to DSM-5 criteria (American Psychiatric Association, 2013; K-SADS-PL)
  • In the control group :
  • Absence of mental disorder according to DSM-5 criteria (American Psychiatric Association, 2013; K-SADS-PL and SIDP-IV)
  • Oral and written comprehension of the French language
  • Informed consent signed by the legal representative, the holder (s) of the exercise of parental authority and the adolescent herself

You may not qualify if:

  • \- Illiteracy / illiteracy
  • Sensory disorder (visual, auditory)
  • Severe chronic psychiatric comorbidity: autism spectrum disorder, intellectual disability, schizophrenia spectrum disorder and other psychotic disorders, bipolar disorder
  • Severe or current brain pathology (chronic neurological disease, encephalitis, history of severe head trauma), alertness disorder
  • History of anoxic coma
  • Contraindication to MRI (magnetic foreign body, claustrophobia, contraindication to prolonged lying down)
  • Severe physical pathology in progress
  • Moving outside the Normandy region planned within 18 months
  • Intellectual deficit (IQ \<70)
  • Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, France

RECRUITING

MeSH Terms

Conditions

Borderline Personality DisorderStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Personality DisordersMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Central Study Contacts

Fabian Guénolé, Pr.

CONTACT

Bérengère Guillery-Girard, Ass.Pr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2021

First Posted

April 21, 2021

Study Start

March 11, 2022

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

July 25, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations