Ketamine Infusion Study for Symptom Improvement in Patients with Severe Borderline Personality Disorder

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Ketamine on individuals with a mental health condition known as Borderline Personality Disorder (BPD). BPD is a condition characterized by intense emotions, unstable relationships, and impulsive behaviors. The study aims to explore whether Ketamine, administered through an intravenous infusion, can help improve the symptoms of severe BPD. Participants will receive two doses of Ketamine at specific intervals, alongside their usual care.

The purpose of this study is to observe changes in the intensity of BPD symptoms over a short period. Participants will be monitored for changes in their symptoms from the start of the study to the ninth day. The study will also look at other aspects, such as changes in suicidal thoughts and depressive symptoms, as well as any potential side effects of Ketamine. The study will collect information on any new hospitalizations or emergency visits related to psychiatric issues during the study period.

This trial is a pilot study, meaning it is an initial, smaller-scale study to gather preliminary data. The information collected will help researchers understand the potential benefits and risks of using Ketamine for treating severe BPD and guide future research in this area. Participants will be closely monitored throughout the study to ensure their safety and well-being.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying the diagnosis of borderline personality disorder and ensuring that current treatments have been stable for at least four weeks.

2 first ketamine infusion

The first dose of ketamine will be administered through an intravenous infusion. The dosage will be 0.5 mg per kilogram of body weight. This infusion will take place at the start of the study.

3 second ketamine infusion

A second dose of ketamine will be administered 24 hours after the first infusion. The dosage will remain the same, at 0.5 mg per kilogram of body weight.

4 symptom evaluation

On day 9, the intensity of borderline personality disorder symptoms will be evaluated using a self-rated scale called BSL-23. This will help measure any changes in symptoms since the start of the study.

5 follow-up assessments

Additional assessments will be conducted at various times: 48 hours after the first infusion, and then at one month and three months. These assessments will measure changes in symptoms using different scales, including the Zanarini-BPD scale for borderline symptoms, the C-SSRS scale for suicidal thoughts, and the MADRS scale for depressive symptoms.

6 monitoring and reporting

Throughout the study, any serious or non-serious side effects, especially those related to ketamine, will be monitored and recorded. Additionally, the number of new hospitalizations and visits to psychiatric emergencies will be documented from day 9 to three months.

Who Can Join the Study?

Adult patient aged 18 to 65
Must provide free, informed, and written consent
Must be fluent in French
Must have a diagnosis of borderline personality disorder according to DSM5 MINI criteria (meeting 5 out of 9 criteria)
Must have severe borderline personality disorder, indicated by a BSL-23 score greater than 39.1
Must have a stable background treatment for at least four weeks, which can be either:
- Pharmacological treatment (such as antipsychotic, mood stabilizer, or anti-depressant)
- Non-pharmacological treatment (such as schema therapy or DBT, which stands for Dialectical Behavior Therapy)
Must be affiliated with or a beneficiary of a social security system

Who Cannot Join the Study?

Patients with a diagnosis of borderline personality disorder cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Oncopole Claudius Regaud	Toulouse	France

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.10.2024

Trial locations

Investigated drugs:

Ketamine Hydrochloride

Ketamine is a medication that is being tested in this study to see if it can help improve symptoms in people with severe borderline personality disorder. It is given through an IV infusion, which means it is delivered directly into the bloodstream through a vein. The study is looking at how the symptoms change after receiving two doses of Ketamine. Ketamine is known for its ability to quickly affect mood and perception, and researchers are exploring its potential benefits for mental health conditions like borderline personality disorder.

Investigated diseases:

Borderline personality disorder

Borderline Personality Disorder – Borderline Personality Disorder is a mental health condition characterized by pervasive instability in moods, self-image, and behavior. This disorder often leads to impulsive actions and problems in relationships with others. Individuals with this condition may experience intense episodes of anger, depression, and anxiety that can last from a few hours to a few days. The disorder typically begins in early adulthood and can vary in intensity over time. People with Borderline Personality Disorder may have difficulty being alone and often have a pattern of unstable relationships. Emotional instability, feelings of worthlessness, insecurity, impulsivity, and impaired social relationships are common features of this disorder.

Trial ID:

2024-514361-19-00

Protocol code:

RC31/23/0619

Trial Phase:

Therapeutic exploratory (Phase II)

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Ketamine Infusion Study for Symptom Improvement in Patients with Severe Borderline Personality Disorder

What is this study about?

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