Ketamine Infusion for Symptomatic Improvement in Severe Borderline Personality Disorder: A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change in Borderline Personality Disorder Symptom Severity (BSL-23) from Baseline (H0) to Day 9 (J9)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
IV Ketamine Double Infusion (0.5 mg/kg) for Severe Borderline Personality Disorder
干预措施: IV Ketamine (0.5 mg/kg) Infusion - Two Doses Administered 24 Hours Apart for Severe Borderline Personality Disorder (Drug)
结局指标
主要结局
Change in Borderline Personality Disorder Symptom Severity (BSL-23) from Baseline (H0) to Day 9 (J9)
时间窗: Baseline and Day 9 post perfusion
The primary outcome measure is the change in symptom severity of Borderline Personality Disorder (BPD) as assessed by the Borderline Symptom List-23 (BSL-23) from Baseline to Day 9 post perfusion. The BSL-23 is a self-reported scale measuring BPD symptom intensity, with scores ranging from 0 (no symptoms) to 92 (most severe symptoms). A higher score indicates greater symptom severity. The difference in total BSL-23 scores between Baseline and Day 9 will be analyzed to evaluate the short-term impact of IV ketamine treatment on BPD symptoms.
Change in Borderline Personality Disorder Symptom Severity (BSL-23) from Baseline (H0) to Day 9 (J9)
时间窗: Baseline and Day 9 post perfusion
The primary outcome measure is the change in symptom severity of Borderline Personality Disorder (BPD) as assessed by the Borderline Symptom List-23 (BSL-23) from Baseline to Day 9 post perfusion. The BSL-23 is a self-reported scale measuring BPD symptom intensity, with scores ranging from 0 (no symptoms) to 92 (most severe symptoms). A higher score indicates greater symptom severity. The difference in total BSL-23 scores between Baseline and Day 9 will be analyzed to evaluate the short-term impact of IV ketamine treatment on BPD symptoms.
次要结局
- Change in Suicidal Ideation Severity Measured by C-SSRS from Baseline to H48, D9, M1, and M3(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)(From Day 9 (J9) to Month 3 (M3))
- Change in Borderline Personality Disorder Symptom Severity (BSL-23) from Baseline to H48, Month 1 (M1), and Month 3 (M3)(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(Baseline, 48 hours, Day 9, 1 month, and 3 months after first ketamine infusion.)
- Change in Borderline Personality Disorder Symptom Severity (BSL-23) from Baseline to H48, Month 1 (M1), and Month 3 (M3)(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(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(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(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)(From Day 9 (J9) to Month 3 (M3))