SHame prOpensity in bOrderline Personality Disorder (SHOO)

  • STATUS
    Recruiting
  • End date
    Sep 3, 2029
  • participants needed
    688
  • sponsor
    University Hospital, Montpellier
Updated on 3 July 2022
psychiatric disorder
scid
psychotropic drugs
suicide
suicidal
structured clinical interview

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

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).

Details
Condition Borderline Personality Disorder
Treatment Clinical and biological assessments - a 5 Years follow-up
Clinical Study IdentifierNCT03994510
SponsorUniversity Hospital, Montpellier
Last Modified on3 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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