SHame prOpensity in bOrderline Personality Disorder

Официальное название

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

Обзор

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

Подробное описание

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).

Вмешательства

• Другое 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.

Первичные конечные точки

• Level of shame propensity [Срок оценки: At enrollment]
• Level of shame propensity [Срок оценки: 1 year after enrollment]
• Level of shame propensity [Срок оценки: 2 years after enrollment]
• Level of shame propensity [Срок оценки: 3 years after enrollment]
• Level of shame propensity [Срок оценки: 4 years after enrollment]
• Level of shame propensity [Срок оценки: 5 years after enrollment]
• Number of SA compared to the clinical data obtained in baseline [Срок оценки: At enrollment]
• Number of SA compared to the clinical data obtained in baseline [Срок оценки: 1 year after enrollment]
• Number of SA compared to the clinical data obtained in baseline [Срок оценки: 2 years after enrollment]
• Number of SA compared to the clinical data obtained in baseline [Срок оценки: 3 years after enrollment]

Вторичные конечные точки (12)

• Number of SA compared to the biological data obtained in baseline [Срок оценки: At enrollment]
• Number of SA compared to the biological data obtained in baseline [Срок оценки: 1 year after enrollment]
• Number of SA compared to the biological data obtained in baseline [Срок оценки: 2 years after enrollment]
• Number of SA compared to the biological data obtained in baseline [Срок оценки: 3 years after enrollment]
• Number of SA compared to the biological data obtained in baseline [Срок оценки: 4 years after enrollment]
• Number of SA compared to the biological data obtained in baseline [Срок оценки: 5 years after enrollment]
• Suicidal Ideation [Срок оценки: At enrollment]
• Suicidal Ideation [Срок оценки: 1 year after enrollment]
• Suicidal Ideation [Срок оценки: 2 years after enrollment]
• Suicidal Ideation [Срок оценки: 3 years after enrollment]
• Suicidal Ideation [Срок оценки: 4 years after enrollment]
• Suicidal Ideation [Срок оценки: 5 years after enrollment]

Критерии участия

Критерии включения

• To be over 18
• Clinical diagnosis of BPD using the SCID II (Structured Clinical Interview for DSM-IV-Text Reviewed Axis II Personality Disorders)
• Having signed the informed consent
• Able to understand the nature, the purpose and the methodology of the study
• Able to understand and perform the clinical evaluations

Критерии исключения

• Deprived of liberty (by judicial or administrative decision)
• Protected by law (guardianship)
• Exclusion period in relation to another protocol
• Not affiliated to a social security scheme

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• University Hospital of Montpellier — Montpellier

Идентификаторы

NCT: NCT03994510 · RECHMPL18_0286

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗