Ketamine Infusion for Symptomatic Improvement in Severe Borderline Personality Disorder

Официальное название

Ketamine Infusion for Symptomatic Improvement in Severe Borderline Personality Disorder: A Pilot Study

Обзор

The main objective of this pilot study is to evaluate at D9 the evolution of BPD symptoms' intensity(scale BSL-23) in severe BPD patients, after two Ketamine infusions (0.5mg/kg at H0 and H24). The intervention is combined with the first level standard of care : Good Psychiatric Management (GPM). Patients are followed up to 3 months by regular visits conducted by a psychiatrist. Secondary outcomes are monitored including BPD symptoms at different times, suicidal ideation, depressiv symptoms, healthcare use and adverse effects.

Подробное описание

Borderline personality disorder is a burden for patient's life and remains undertreated, no medication has FDA or AMM approval for this indication. On a neurobiological level, BPD is thought to involve defects in the regulation of the glutamatergic pathway, as well as circuit anomalies in the emotional pathways (limbic hyperactivation and deficient activation of the prefrontal cortex), which have been associated with impulsivity and emotional hyper-reactivity. Ketamine, an NMDA antagonist, has a pharmacological profile of interest for TPB, thanks to its excitatory action on the CPF and its inhibitory effect on limbic hyperactivity. Preliminary clinical data suggest an effect on TPB symptomatology, more data is needed to conduct a large scale study.

This pilot study aim to test the effect of two infusions of ketamine (0,5 mg/kg) in adults with severe BPD. The protocol consists of two IV ketamine injections over 40 min at a dose of 0.5 mg/kg each, at H0 and H24.The associated treatment will be in line with first-level recommendations, i.e. GPM-type psychotherapy.

Infusions are delivered under medical monitoring at hospital and patients are followed up to 3 months by regular psychiatric consultations. Change in BPD symptoms'intensity is measured by the scale BSL-23 at different times (baseline, H48, J9, J28, M3) up to 3 months. Suicidal ideations, depressive symptoms, health care sue and adverse effects are also monitored.

Вмешательства

• Препарат IV Ketamine (0.5 mg/kg) Infusion - Two Doses Administered 24 Hours Apart for Severe Borderline Personality Disorder
  Participants receive two intravenous (IV) infusions of ketamine at a dose of 0.5 mg/kg over 40 minutes. The first infusion is administered at Hour 0 (H0) and the second at Hour 24 (H24). Vital signs and potential adverse effects are closely monitored before, during, and after each infusion. This intervention aims to assess the short-term efficacy and safety of ketamine in reducing symptoms of severe borderline personality disorder.

Первичные конечные точки

• Change in Borderline Personality Disorder Symptom Severity (BSL-23) from Baseline (H0) to Day 9 (J9) [Срок оценки: Baseline and Day 9 post perfusion]

Вторичные конечные точки (5)

• Change in Borderline Personality Disorder Symptom Severity (BSL-23) from Baseline to H48, Month 1 (M1), and Month 3 (M3) [Срок оценки: Baseline, 48 hours, 1 month, and 3 months after first ketamine infusion.]
• Change in Borderline Personality Disorder Symptom Severity Measured by Zanarini-BPD Scale from Baseline to H48, D9, M1, and M3 [Срок оценки: Baseline, 48 hours, Day 9, 1 month, and 3 months after first ketamine infusion.]
• Change in Suicidal Ideation Severity Measured by C-SSRS from Baseline to H48, D9, M1, and M3 [Срок оценки: Baseline, 48 hours, Day 9, 1 month, and 3 months after first ketamine infusion.]
• Change in Depressive Symptom Severity Measured by MADRS from Baseline to H48, D9, M1, and M3 [Срок оценки: Baseline, 48 hours, Day 9, 1 month, and 3 months after first ketamine infusion.]
• Number of Psychiatric Emergency Room Visits (Self-Reported, Day 9 to Month 3) [Срок оценки: From Day 9 (J9) to Month 3 (M3)]

Критерии участия

Критерии включения

• Adult patient aged 18 to 65 years
• Fluent in French
• Person affiliated with or receiving social security benefits.
• Diagnosis of borderline personality disorder established according to the DSM-5 MINI criteria (5 out of 9 criteria)
• Severe borderline personality disorder
• Patient receiving stable pharmacological (antipsychotic, mood stabilizer, antidepressant) and/or non-pharmacological (schema therapy, DBT) treatment for four weeks

Критерии исключения

• Personal history of an acute psychotic episode or chronic psychotic disorder
• Personal history of a manic or hypomanic episode
• Family history (first-degree relatives) of a psychotic disorder
• Current severe depressive episode
• Recreational ketamine use (multi-weekly ketamine use)
• New long-term treatment introduced within the previous four weeks (antidepressant, antipsychotic, mood stabilizer)
• Prescription of an Monoamine oxidase inhibitors (increased risk of hypertension)
• Specific absolute contraindication to ketamine
• History of cirrhosis or major liver function test abnormalities
• Major ECG abnormality

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Toulouse Purpan University Hospital, Head of Psychiatry Clinic in the UF3 department — Toulouse

Идентификаторы

NCT: NCT07099534 · RC31/23/0619 · 2024-514361-19-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗