Trials / Recruiting
RecruitingNCT03994510
SHame prOpensity in bOrderline Personality Disorder
Study of Shame Propensity as a Prognostic Factor of Suicidal Behaviors in Patients With Borderline Personality Disorder
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 688 (estimated)
- Sponsor
- University Hospital, Montpellier · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Detailed 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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Clinical and biological assessments - a 5 Years follow-up | During each visit, a clinical evaluation will be carried out, as well as the filling of hetero-questionnaires and self-questionnaires. Two biological collections will be made: one during the inclusion visit, and the other during the last visit, 5 years after inclusion. |
Timeline
- Start date
- 2020-09-18
- Primary completion
- 2031-09-01
- Completion
- 2031-09-01
- First posted
- 2019-06-21
- Last updated
- 2025-09-30
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03994510. Inclusion in this directory is not an endorsement.