Borderline Personality DisorderNCT03519035
Study of Hallucinations in Patients With Borderline Personality Disorder
An observational study of Borderline Personality Disorder, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Hallucinations in borderline personality disorder are a frequent an serious trouble which have an important impact in patients lives. Despite this, they are often ignored by nursing staff, and are not an important criteria in Diagnostic and Statistical Manual (DSM) 5 and Classification Internationale des maladies… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- To pass different questionnaires
- How many people
- 317 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2018to Jul 2021
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with borderline personnality disorder (BPD) and they will be recruited in the different services.
Who may be able to join
- Patient aged 18 and under 75
- Patient with borderline personality disorder (formerly or newly diagnosed diagnosis)
- Patient having given his opposition to his participation in research
Who cannot join
- Schizophrenia
- Major depressive episode characterized in progress
- Manic or hypomanic episode in progress
- History of head trauma
- Stroke, Parkinson's disease, dementia
- Autism
Show all 11Show fewer
- Mental retardation
- Patient under the age of 75
- Patient who does not read or speak French
- Patient unable to give consent (includes protected persons: guardianship, trusteeship)
- Incarcerated patient
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital Toulouse
Toulouse, 31059
Anjali Mathur, MD, 05 61 77 22 33 ext. 33, mathur.a@chu-toulouse.fr
Isabelle Olivier, PhD, 05 61 77 70 51 ext. 33, olivier.i@chu-toulouse.fr
About this study
Official title: Study of Prevalence and Characteristics of Hallucinations in Patients With Borderline Personality Disorder
Hallucinations in borderline personality disorder are a frequent an serious trouble which have an important impact in patients lives. Despite this, they are often ignored by nursing staff, and are not an important criteria in Diagnostic and Statistical Manual (DSM) 5 and Classification Internationale des maladies (CIM-10). The main objective of our study is to assess the prevalence of this trouble in borderline personality disorder (BPD) population, and to characterize the hallucinations in order to compare our results with those of international studies.
Read the detailed description
The borderline personality disorder (BPD) is a very common personality disorder which concerns about 1.35% of total population. It is characterized by an affective, emotional, social and professional instability and an important association with comorbidities like mood disorders, post-traumatic stress disorder, addictive problems and suicide mortality. Hallucinations seem to be frequent in this personality disorder, but are not often taken in consideration by nursing staff because of massive need of attention of this kind of patient. At this moment there is no study of prevalence of this trouble in France in free environment. In the same way, there is no qualitative study about hallucinations. That is why we can do a lot of progress in this part of psychiatry.
This research is an observational study of descriptive type. Patients will be recruited in the different services. In this study, patients will have to pass different questionnaires (DIB-R, DES II, THQ, PCL-S, PSAS, qualitative questionnaire) in order to compare the characteristics between BDL patients with and without hallucinations.
For that, the investigator will meet each patient twice, after information by the medical staff of the service and consent. During the first meeting, the investigator will get the socio-demographic characteristics, the verification of inclusion and non-inclusion criteria, and the DIB-R questionnaire to know if the patient has really BPD and hallucinations or not. This is the same interview for all patients. During the second meeting, we will look for dissociative symptoms with DES II questionnaire, then traumatic symptoms and post-traumatic stress disorder with THQ and PCL-S. The PSAS and qualitative questionnaire will be used for BPD patients with hallucinations.
- Conditions
- Borderline Personality Disorder
- Being tested
- To pass different questionnaires
- Keywords
- borderline, hallucinations, dissociation, post-traumatic stress disorder
- Medical subject headings
- Borderline Personality Disorder, Hallucinations, Dissociative Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To pass different questionnairesOther
Patients will have to pass different questionnaires (DIB-R, DES II, THQ, PCL-S, PSAS, qualitative questionnaire) in order to compare the characteristics between BDL patients with and without hallucinations.
| Study group | Role | What they receive |
|---|---|---|
| Borderline personality disorder Patient | Patients will be recruited in the different services. They have to respect inclusion criteria which are : patient with BPD (clinical diagnosis), patients 18 years of age or older, patients who can give their consent.
In this study, patients will have to pass different questionnaires (DIB-R, DES II, THQ, PCL-S, PSAS, qualitative questionnaire) in order to compare the characteristics between BDL patients with and without hallucinations. Receives: Other: To pass different questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of hallucination
During the first interview with the passage of the DIB-R scale It consists of determining whether or not hallucinations have occurred during the patient's life. This criterion will allow the outcome of the study to estimate the prevalence (over the last two years (as specified by the DIB-R questionnaire) but also over the lifetime to obtain additional data) hallucinatory manifestations in patients with a BDL course.
All patients will have the same first interview, with questionnaires about socio-demographic characteristics, inclusion and non-inclusion criteria, consent
Measured: 1 day
Secondary outcomes (4)
Description of the patient's hallucinations
Qualitative study of hallucinations (for patients who said they had or had had them during the first interview).
The Scale used is PSAS : a questionnaire for the characteristics of hallucinations When establishing the protocol, the PSAS (Psycho-Sensory Hallucinations Scale) was chosen because it is one of the only scales studying the different types of hallucinations (auditory, visual, coenesthetic, olfactory and tasteful) validated in French.
Measured: 1 day
Search for dissociative elements
Search for dissociative elements in the patient with the scale: DES-II DES-II is a self-questionnaire to detect individuals with a dissociative disorder or disorder with a high dissociative component, as well as to quantify dissociative experiences. It consists of 28 questions on situations in which the subject indicates, in percentage, the frequency with which each situation occurs.
Measured: 1 day
Investigation of traumatic elements
Investigation of traumatic elements and post-traumatic stress disorder (PTSD) with the scales used: THQ THQ is a self-administered questionnaire consisting of 24 closed questions (yes / no) evaluating the presence of a number of potentially traumatic events in the life of an individual. They are divided into 3 categories (crime, natural disasters and traumas, physical and sexual experiences)
Measured: 1 day
Investigation of traumatic elements
Investigation of traumatic elements and post-traumatic stress disorder (PTSD) with the scales used: PCL-S PCL-S is a self-administered questionnaire that evaluates the symptoms of PTSD. It is translated into French and validated for the detection and monitoring of PTSD. It assesses the existence of PTSD symptoms related to a specific and identified traumatic event. In this study we define the specific traumatic event with the patient before the handover. The questionnaire consists of 17 questions around the main symptoms described by the DSM-IV
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study startJul 2018 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 317 participants (estimated)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anjali Mathur, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519035
- Sponsor's protocol ID
- RC31/18/0035
- Other IDs
- 2018-A00251-54
- Status last verified
- Jul 2018
- First submitted
- 16 Apr 2018
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Prevalence and Characteristics of Hallucinations in Patients With Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT03519035
- Acronym / sponsor ID
- RC31/18/0035
- Conditions
- Borderline Personality Disorder
- Keywords
- borderline, hallucinations, dissociation, post-traumatic stress disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 317 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 8 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hallucinations in borderline personality disorder are a frequent an serious trouble which have an important impact in patients lives. Despite this, they are often ignored by nursing staff, and are not an important criteria in Diagnostic and Statistical Manual (DSM) 5 and Classification Internationale des maladies (CIM-10). The main objective of our study is to assess the prevalence of this trouble in borderline personality disorder (BPD) population, and to characterize the hallucinations in order to compare our results with those of international studies.
Detailed description
The borderline personality disorder (BPD) is a very common personality disorder which concerns about 1.35% of total population. It is characterized by an affective, emotional, social and professional instability and an important association with comorbidities like mood disorders, post-traumatic stress disorder, addictive problems and suicide mortality. Hallucinations seem to be frequent in this personality disorder, but are not often taken in consideration by nursing staff because of massive need of attention of this kind of patient. At this moment there is no study of prevalence of this trouble in France in free environment. In the same way, there is no qualitative study about hallucinations. That is why we can do a lot of progress in this part of psychiatry.
This research is an observational study of descriptive type. Patients will be recruited in the different services. In this study, patients will have to pass different questionnaires (DIB-R, DES II, THQ, PCL-S, PSAS, qualitative questionnaire) in order to compare the characteristics between BDL patients with and without hallucinations.
For that, the investigator will meet each patient twice, after information by the medical staff of the service and consent. During the first meeting, the investigator will get the socio-demographic characteristics, the verification of inclusion and non-inclusion criteria, and the DIB-R questionnaire to know if the patient has really BPD and hallucinations or not. This is the same interview for all patients. During the second meeting, we will look for dissociative symptoms with DES II questionnaire, then traumatic symptoms and post-traumatic stress disorder with THQ and PCL-S. The PSAS and qualitative questionnaire will be used for BPD patients with hallucinations.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Borderline personality disorder Patient | – | Other: To pass different questionnairesPatients will be recruited in the different services. They have to respect inclusion criteria which are : patient with BPD (clinical diagnosis), patients 18 years of age or older, patients who can give their consent. In this study, patients will have to pass different questionnaires (DIB-R, DES II, THQ, PCL-S, PSAS, qualitative questionnaire) in order to compare the characteristics between BDL patients with and without hallucinations. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with borderline personnality disorder (BPD) and they will be recruited in the different services.
Key inclusion criteria (3 listed)
- Patient aged 18 and under 75
- Patient with borderline personality disorder (formerly or newly diagnosed diagnosis)
- Patient having given his opposition to his participation in research
Key exclusion criteria (11 listed)
- Schizophrenia
- Major depressive episode characterized in progress
- Manic or hypomanic episode in progress
- History of head trauma
- Stroke, Parkinson's disease, dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| To pass different questionnairesPatients will have to pass different questionnaires (DIB-R, DES II, THQ, PCL-S, PSAS, qualitative questionnaire) in order to compare the characteristics between BDL patients with and without hallucinations. | Other | Borderline personality disorder Patient |
Primary outcome
Presence or absence of hallucination
Time frame: 1 day
During the first interview with the passage of the DIB-R scale It consists of determining whether or not hallucinations have occurred during the patient's life. This criterion will allow the outcome of the study to estimate the prevalence (over the last two years (as specified by the DIB-R questionnaire) but also over the lifetime to obtain additional data) hallucinatory manifestations in patients with a BDL course. All patients will have the same first interview, with questionnaires about socio-demographic characteristics, inclusion and non-inclusion criteria, consent
4 secondary outcomes
Description of the patient's hallucinations
Time frame: 1 day
Search for dissociative elements
Time frame: 1 day
Investigation of traumatic elements
Time frame: 1 day
Investigation of traumatic elements
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Borderline Personality Disorder
Recruiting
Repetitive Transcranial Magnetic Stimulation Versus Theta Burst Stimulation on Impulsivity, Emotional Dysregulation, and Non-Suicidal Self-Injury in Borderline Personality Disorder Patients
Borderline Personality Disorder (BPD)
Not yet recruitingPhase 2
Ketamine Infusion for Symptomatic Improvement in Severe Borderline Personality Disorder
Infusion of Ketamine in Severe Borderline Personality Disorder, Borderline Personality Disorder (BPD)
Recruiting
Combining Transcranial Magnetic Stimulation With Emotion Regulation Skills Training in Borderline Personality Disorder
Borderline Personality Disorder (BPD)
RecruitingPhase 2
MDMA in Borderline Personality Disorder
Borderline Personality Disorder
Active, not recruitingPhase 2
Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder
Borderline Personality Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anjali Mathur, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Borderline Personality Disorder, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anjali Mathur, MD (05 61 77 22 33 ext. 33, mathur.a@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of hallucination (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.