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Recruiting NCT04852744

NCT04852744 NEUROIMAGING OF ADOLESCENT BORDERLINE PERSONALITY DISORDER WITH AND WITHOUT POST-TRAUMATIC STRESS DISORDER

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Clinical Trial Summary
NCT ID NCT04852744
Status Recruiting
Phase
Sponsor University Hospital, Caen
Condition Borderline Personality Disorder
Study Type INTERVENTIONAL
Enrollment 99 participants
Start Date 2022-03-11
Primary Completion 2027-12-01

Eligibility & Interventions

Sex Female only
Min Age 13 Years
Max Age 18 Years
Study Type INTERVENTIONAL
Interventions
Brain MRI

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 99 participants in total. It began in 2022-03-11 with a primary completion date of 2027-12-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: * \- 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 * The inclusion of the subject in another biomedical research protocol (during the present study) * Intellectual deficit (IQ \<70) * Pregnant or breastfeeding women

Contact & Investigator

Central Contact

Fabian Guénolé, Pr.

✉ guenole-f@chu-caen.fr

📞 +33 (0) 231 272 309

Frequently Asked Questions

Who can join the NCT04852744 clinical trial?

This trial is open to female participants only, aged 13 Years or older, up to 18 Years, studying Borderline Personality Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT04852744 currently recruiting?

Yes, NCT04852744 is actively recruiting participants. Contact the research team at guenole-f@chu-caen.fr for enrollment information.

Where is the NCT04852744 trial being conducted?

This trial is being conducted at Caen, France.

Who is sponsoring the NCT04852744 clinical trial?

NCT04852744 is sponsored by University Hospital, Caen. The trial plans to enroll 99 participants.

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