SHame prOpensity in bOrderline Personality Disorder — SHOO  

Borderline Personality Disorder Clinical Trial

Official title: Study of Shame Propensity as a Prognostic Factor of Suicidal Behaviors in Patients With Borderline Personality Disorder

Status Recruiting

Clinical Trial Summary

Borderline Personality Disorder (BPD) is a common psychiatric disorder occurring in 2 to 6% of the population. 70% of patients with BPD do at least one Suicide Attempt (SA) in their lives. It makes BPD the most related to SA condition.

Negative interpersonal events are among the main stressor inducing a SA. Patients with BPD are characterized by emotional dysregulation, impulsivity (repeated parasuicidal and suicidal behaviors), and instability in interpersonal relationships. The feeling of shame related to this psychiatric disorder could be one of the causes of the high SA rate. In this study, patients with BPD will be follow-up during 5 years.

The main objective is to study the propensity to feel shame as a predictor of SA.

This include:

• Study of shame propensity as a predictive factor of suicidal behavior - Identify homogeneous subgroups of patients with BPD based on SA, and overall functioning.

• Identify biological markers predicting SA

• Identify predictive and protective treatments (pharmacological and psychotherapeutic) for SA

Clinical Trial Description

This is a 5 years follow-up prospective study recruiting 688 patients.

Schedule of the study :

Inclusion period : 3 years Duration of follow-up of each patient : 5 years Estimated duration of the study : 8.5 years

As part of the research, patients will be summoned annually for 5 years.

The first visit (at baseline) is included in the usual care

The follow-up visits are specifics to the research

During the visits patients will complete self questionary and clinical interview.

The organization of visits is as follows:

• an inclusion visit lasting around 2 hours (clinical evaluation and then self-questionnaires)

• a visit to 1 year, 2 years, 3 years, 4 years and 5 years (+/- 1 month) lasting approximately 1 hour 30 (clinical evaluation and passing of self-questionnaires)

Genetic samples will be taken during the initial visit as well as during the visit to 5 years.

They consist of:

• A genetic collection consisting of a DNA library (3 Ethylene Diamine Triacetic Acid (EDTA) tubes of 6ml - 18 ml).

• An off-genetics collection consisting of serum and plasma samples, (1 6 ml EDTA tube, 1 4 ml heparinized tube, 2 dry tubes of 5 ml each and 2 citrated tubes of 2.7 ml each - 25 , 4 ml). ;

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Disease
• Personality Disorders

• NCT number: NCT03994510
• Study type: Interventional
• Source: University Hospital, Montpellier
• Contact: Déborah DUCASSE, MD, PhD
• Phone: (0)467338581
• Email: d-ducasse@chu-montpellier.fr
• Status: Recruiting
• Phase: N/A
• Start date: September 18, 2020
• Completion date: September 2029