AuthorisedTherapeutic exploratory (Phase II)Interventional

Ketamine infusion for symptomatological improvement of severe borderline personality disorder: a pilot study

This research is a pilot study, meaning it's a small, early-stage trial to see if a particular treatment might be effective. It's investigating if a ketamine infusion (a drip directly into the bloodstream) can help adults aged 18 and over who have severe Borderline Personality Disorder (BPD). The main goal is to see if participants experience an improvement in their BPD symptoms nine days after starting the treatment. Researchers will also look at whether the treatment helps with suicidal thoughts and depression, how many people need hospital visits, and if there are any side effects. Both men and women can take part in this study.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier Universitaire De Toulouse

Enrolment target

Start

18 Oct 2024

borderline personality disorder

What is this study about?

This study is a pilot trial looking at a treatment for severe Borderline Personality Disorder (BPD). BPD is a mental health condition that can cause intense emotional swings, impulsive behaviour, and difficulties with relationships. People with BPD often experience significant distress and challenges in their daily lives. This research is exploring whether giving a controlled amount of ketamine through an infusion (a drip) could help to reduce some of these severe symptoms.

The main aim of this study is to see if there's an improvement in BPD symptoms just nine days after starting the ketamine treatment. To do this, participants will answer questions about their symptoms using a self-assessment scale. Researchers will compare how severe their symptoms were at the beginning of the study to how they are after nine days. They will also continue to check on symptoms at later time points, such as six weeks and three months.

Beyond BPD symptoms, the study will also look at other important areas. They will check if the ketamine infusion helps to lessen suicidal thoughts or symptoms of depression. They'll also keep track of how many participants need to visit a hospital or psychiatric emergency department. A very important part of the study is to carefully record any side effects experienced by participants, especially those that might be linked to the ketamine treatment. This helps ensure safety and understand if the potential benefits outweigh any risks.

Key takeaways

This is an early-stage study testing ketamine for severe BPD.
It aims to see if ketamine infusions can reduce BPD symptoms, suicidal thoughts, and depression.
Participation involves receiving ketamine via a drip and follow-up assessments over three months.
Open to adults aged 18 and over with severe BPD, both men and women.
Safety monitoring and reporting of side effects are key parts of the study.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be an adult, meaning you are 18 years old or older. There is no upper age limit, so people of all adult ages can be considered. The study is open to everyone, regardless of whether they are male or female.

The most important health condition for this study is having severe Borderline Personality Disorder. This means your BPD symptoms are causing significant difficulties in your life and are considered serious by medical professionals. The study will likely have other specific health requirements or conditions that might prevent someone from joining, even if they have BPD. These could include certain other medical conditions or medications you might be taking, but the full list isn't provided here.

If you are interested in taking part, a healthcare professional involved in the study would need to review your full medical history to confirm if you meet all the necessary criteria and if it would be safe and appropriate for you to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Am I 18 years old or older?
Do I have a diagnosis of severe Borderline Personality Disorder (BPD)?
Am I able to attend regular appointments for treatment and check-ups?
Am I comfortable completing questionnaires about my mental health?
Do I understand that this is a research study with potential benefits and risks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive a course of ketamine delivered through an infusion. This means the medicine goes directly into your bloodstream through a drip, likely in a hospital or clinic setting. You would have assessments at the very beginning of the study to measure your symptoms. Then, after receiving the treatment, you would have several follow-up appointments.

These follow-up appointments involve answering questions about your BPD symptoms, suicidal thoughts, and any depression you might be experiencing. These checks will happen at various times, including 48 hours, 9 days, one month, and three months after your initial treatment. You would also be asked to report if you've needed to go to a hospital or psychiatric emergency department during the three months after your treatment. Throughout the study, nurses and doctors will carefully monitor you for any side effects, both serious and minor. The total duration of your participation in the study, including follow-up, would be approximately three months.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit if the ketamine treatment helps to improve your severe BPD symptoms, suicidal thoughts, or depression. However, as with any new treatment, there are also potential risks, including side effects from the ketamine. These could range from mild to serious, and the research team will carefully monitor you for any adverse effects. You will be given detailed information about these before deciding to join. It is very important to remember that participating in a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
France

Common questions

What is ketamine, and is it safe?

Ketamine is a medicine that is usually used as an anaesthetic or for pain relief. This study is looking at a different use for it. The study will carefully monitor its safety when used for BPD symptoms.

How will my symptoms be measured?

You will be asked to fill in questionnaires about your BPD symptoms, suicidal thoughts, and feelings of depression. These are scales that help doctors understand how you're feeling over time.

Do I have to go to hospital?

This study involves receiving ketamine through an infusion, which usually means spending some time in a hospital or clinic setting for the treatment itself. There will also be follow-up visits.

What if my symptoms get worse during the study?

The research team will be carefully monitoring your well-being. If your symptoms worsen or you have any concerns, it's crucial to tell the study team immediately so they can provide appropriate help and support.

Will I know if I'm getting the real ketamine treatment?

This study is described as an 'exploratory' study, which often means everyone receives the active treatment. However, sometimes studies compare the treatment to a placebo (a dummy treatment). The study team will explain exactly what you would receive.