Drug therapy to alleviate the symptoms of borderline personality disorder

Do you suffer from borderline personality disorder?

You have the opportunity to take part in a clinical trial that is investigating a new drug therapy to alleviate the symptoms of borderline personality disorder.

Which medication is being studied?

If you suffer from borderline personality disorder (BPD), you know how much this condition can affect and stress your everyday life. Mood swings, impulsive behaviour, persistent difficulties in dealing with other people, self-harm - these are all possible symptoms. This clinical trial was planned to investigate whether a new drug, tentatively named BI 1358894, can help people with BPD. In animal models, BI 1358894 has been shown to potentially interfere in a regulatory way with those areas of the human brain involved in emotion control. This potential effect of BI 1358894 in humans will now be tested in this study. BI 1358894 has not yet been approved in any country for the treatment of psychiatric diseases.

Who can participate in this clinical trial?

Men and women with confirmed BPD who are between 18 and 65 years old.
You must not have had any inpatient stays due to worsening of your BPD symptoms in the 3 months before you start the study.
If you are undergoing psychotherapy, the type and frequency of psychotherapy must not have changed in the 3 months before you start the study.
If you are a woman of childbearing potential, you must be willing to adhere to strict contraceptive guidelines while participating in the study. This includes, for example, taking an anti-baby pill and additionally using a condom during sexual intercourse. There are other requirements for participation that the study doctors will discuss with you.

What is the clinical trial procedure?

To find out if the new medicine helps people with BPH, it will be compared to a placebo. The placebo looks exactly like the new medicine, but it does not contain any active ingredient. A computer system randomly assigns you to treatment with the new drug or placebo. The probability of receiving the new drug is the same for each participant. During the study
neither you nor the study team will know whether you will get the new medicine or placebo. In this study, you will take the tablets every morning for 12 weeks. For the first 4 weeks, you will come to your study centre once a week for assessment visits. After that, you will only come to your study centre for visits every fortnight, and in the weeks in between, your study team will call you at an agreed time to check how you are doing.

During this period, a visit to the study centre will last on average about 3 hours (+/-), a telephone visit about 30 minutes. During your visits to the centre, you will be examined physically and have blood taken. In addition, neuropsychological examinations are carried out by interview and questionnaires. If you wish, you can take part in two additional examinations, during which a magnetic resonance imaging, or MRI, of your brain will be performed. You will be asked by your study team if you would like to take part in these additional examinations. At home, you will take your study medication every morning and document your tablet intake with a video recording using a smartphone app. Using this app, you will also answer questions about your current emotional state several times a day for a total of 12 days. In total, your participation in the study will last approx. 5 months, as in the 4 weeks before and after the treatment period, there will be 2 further examination visits at the centre as part of a pre- and post-treatment examination. All study-related examinations and the new medication are free of charge for you. You will receive an expense allowance per visit and your travel expenses will also be reimbursed.

The sponsor of this clinical trial has submitted a protocol that describes all study activities in detail. An independent review board, whose job it is to protect the rights and safety of study participants, has reviewed and approved this protocol. The approved protocol must be followed closely by your study team.

What are the benefits and risks associated with the study?

As with any research study, there is no guarantee that you will benefit from taking part in this study. However, your participation may help to improve
improve the treatment of people with BPD in the future. It is possible that side effects may occur during treatment. If you are interested in taking part, you will be told about the risks and possible side effects before you start the study.

Why is this clinical trial being done?

Borderline personality disorder affects the everyday life of the affected person. Even simple activities can become a challenge. The most important component of treatment for BPD is still psychotherapy.
New treatments are being sought to widen the scope of treatment. As yet, there are no medications that can cure BPD. Research teams are working to develop a drug therapy that could help. The goal is to find a drug that reduces the symptoms of BPD and improves the quality of life for those with the condition. In order to investigate new drug therapies, clinical trials are needed and people who want to take part in these clinical trials.
Participants have the opportunity to receive a new drug. However, there is no guarantee that participation or the new drug will bring any personal benefit.
It is also possible that adverse events will occur. Adverse events are health problems of any kind that may occur during participation in a study. Therefore, the health of the participants in a clinical trial is closely monitored. Participants in clinical trials help scientists to better understand the disease and to develop new treatments for people with the disease in the future.

Who can I contact at the University Hospital Bonn if I am interested in participating in the study?

Claudia Hanses is responsible for coordinating the study. She can be contacted via e-mail at claudia.hanses(at)ukbonn.de or by telephone at 0228/287-31371 or -31916.
The study director for the Bonn study centre is Prof. Dr. Alexandra Philipsen, Medical Director of the Clinic and Polyclinic for Psychiatry and Psychotherapy (e-mail: ). Her deputy is Dr Henrik Rohner (e-mail: ).

Where can I find further information?

You can find more information in English at: www.clinicaltrials.gov (search for NCT number 04566601) or www.clinicaltrialsregister.eu (search for EudraCT number 2020-000078-12).

Boehringer Ingelheim is sponsoring this clinical trial. The full study title is:

Study to test the efficacy and safety of different doses of BI 1358894 in patients with borderline personality disorder.

Further information about this clinical trial can also be found at the following internet address: https://www.viomedo.de/ (search term: 1402-0012).