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Borderline personality disorder Trials in Disease

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In short

There are currently 2 clinical trials investigating new treatment approaches for borderline personality disorder. These studies are exploring the use of Ketamine infusions and Oxytocin combined with Self-Compassion Training to help improve symptoms and emotional well-being in people living with this condition.

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

This clinical trial, conducted in France, is investigating whether Ketamine can help improve symptoms in people with severe borderline personality disorder. The study focuses on understanding how this medication, given through an intravenous infusion, might reduce the intensity of symptoms associated with the condition.

Inclusion criteria: To participate in this study, individuals must be adults between 18 and 65 years old with a confirmed diagnosis meeting at least 5 out of 9 criteria for borderline personality disorder according to standardized diagnostic guidelines. Participants must have severe symptoms, indicated by a specific score on a symptom scale, and their current treatment must have been stable for at least four weeks. This treatment can include medications like antipsychotics, mood stabilizers, or antidepressants, or psychological therapies such as Dialectical Behavior Therapy or schema therapy. Participants must be fluent in French and provide written informed consent.

Exclusion criteria: Individuals outside the specified age range or those considered part of a vulnerable population cannot take part in this study.

Focus and goal: The trial aims to observe changes in symptom intensity over a short period, specifically measuring improvements by day 9 after treatment begins. Researchers will also monitor changes in suicidal thoughts, depressive symptoms, and any potential side effects. Additionally, the study will track any new psychiatric hospitalizations or emergency visits during the study period. This is a pilot study designed to gather preliminary information about the potential benefits and risks of using Ketamine for severe borderline personality disorder.

Investigational drug: Ketamine is administered through an IV infusion at a dose of 0.5 mg per kilogram of body weight. Participants will receive two infusions, 24 hours apart. Ketamine is known for its rapid effects on mood and perception, and works by blocking specific receptors in the brain called NMDA receptors. While traditionally used as an anesthetic, researchers are exploring its potential to help with mood and emotional regulation in mental health conditions.

Study on Oxytocin and Self-Compassion Training for Patients with Borderline Personality Disorder

This Spanish clinical trial is testing a combination treatment approach that includes oxytocin nasal spray and Self-Compassion Training. The study aims to understand whether this combination can help individuals with borderline personality disorder develop a kinder attitude toward themselves and improve their overall symptoms.

Inclusion criteria: Participants must be between 18 and 50 years old with a confirmed diagnosis established through specialized personality disorder assessment interviews. They must have stable medication during the study period and have previously received Dialectical Behavioral Therapy or training in its skills. Additionally, participants must demonstrate high levels of self-criticism, as measured by specific assessment scores.

Exclusion criteria: Individuals without a diagnosis of the condition, those outside the specified age range, and people unable to provide informed consent cannot participate in this study. Both males and females are eligible.

Focus and goal: The study evaluates whether combining oxytocin with Self-Compassion Training can improve self-compassion levels and reduce symptoms. Researchers will measure various aspects including self-compassion, self-criticism, symptom severity, anger levels, life satisfaction, well-being, and daily functioning. The trial explores whether oxytocin can make participants more receptive to psychological therapy, potentially enhancing treatment outcomes.

Investigational treatments: Oxytocin is a hormone naturally associated with social bonding and emotional regulation. In this trial, it is delivered as a nasal spray at a concentration of 40 U.I./ml. The hormone works by binding to specific receptors in the brain that influence social behaviors and emotions. Self-Compassion Training is a therapeutic approach that teaches individuals to be understanding and kind to themselves, particularly during challenging times. This training aims to reduce self-criticism and increase self-acceptance, helping participants develop healthier emotional responses.

Summary

Currently, two clinical trials are actively recruiting participants for borderline personality disorder research, one in France and one in Spain. These studies represent different approaches to treatment: one focuses on rapid symptom relief through medication, while the other combines hormonal therapy with psychological training to address emotional regulation and self-perception.

The French trial explores Ketamine, a medication traditionally used as an anesthetic, for its potential rapid effects on severe symptoms. The Spanish study takes a more integrative approach, combining oxytocin with Self-Compassion Training to enhance the therapeutic process. Both studies require participants to have confirmed diagnoses and stable current treatments, ensuring that any changes observed can be attributed to the investigational treatments.

These trials reflect ongoing efforts to find new and more effective ways to help people living with borderline personality disorder manage their symptoms and improve their quality of life. The limited number of trials highlights the need for continued research in this area.

This guide is here to help you understand the condition. It does not replace a conversation with your doctor, who knows your situation best.

Clinical trials for Borderline personality disorder

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3 clinical trials in this condition

Countries:SpainSpain
  • Participants:18–64 years
  • Substances:Oxytocin
  • Sponsor:Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
Countries:GermanyGermany
  • Participants:18–64 years
  • Substances:Adezunap
  • Sponsor:Apurano Pharmaceuticals GmbH
Registered drug
Countries:FranceFrance
  • Participants:18–64 years · 65+ years
  • Substances:Ketamine Hydrochloride
  • Sponsor:Centre Hospitalier Universitaire De Toulouse
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