2024-514361-19-00招募中2 期
Ketamine infusion for symptomatological improvement of severe borderline personality disorder: a pilot study
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Our primary outcome measures the difference of BPD symptoms’s intensity at BSL-23 (self-rated scale) from baseline to D9
研究概览
简要总结
The main objective of this pilot study is to evaluate on day 9, in patients with severe borderline personality disorder (BPD), the evolution of the intensity of BPD symptoms (BSL) after the administration of two doses of Ketamine by IV infusion ( 0.5 mg/kg at 0 and 24 hours) in combination with the recommended first level care.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Adult patient aged 18 to 65
- •Free, informed and written consent
- •Fluency in French
- •Diagnosis of borderline personality disorder according to DSM5 MINI criteria (5 out of 9 criteria)
- •Severe borderline personality disorder: BSL-23 score > 39.1
- •Patient having a background pharmacological treatment (antipsychotic, mood stabilizer, anti-depressant) and/or non-pharmacological (schema therapy, DBT) stable for four weeks
- •Person affiliated to or beneficiary of a social security system.
排除标准
- •lifetime diagnosis or episode of psychotic disorder for the participant or for a first degree relative
- •specific absolute contraindication to ketamine: severe failure, stroke/TIA within the previous year, uncontrolled hypertension(BP>140/90), known hypersensitivity to ketamine, known Brugada syndrome or Major ECG abnormality (QTc>450ms)
- •Major ECG abnormality (corrected QT > 450 ms; ST segment abnormalities)
- •Cirrhosis or history of major disturbance in liver function tests (AST or ALT >2N or bilirubin >1,5 N)
- •hepatic or cutaneous porphyria
- •Participation in another interventional study involving humans or being in the exclusion period following previous research if applicable
- •Any reason clinically significant at inclusion baseline wich in the opinion of the investigator could compromise the safety of the participant
- •Protection measure for property and the person in progress (protection of justice, curatorship, guardianship)
- •Pregnant or breastfeeding woman
- •History of a manic or hypomanic episode
- •current severe depressive episode: MADRS > 35 before inclusion
- •ketamine abuse (ketamine taken several times a week)
- •Family history (first degree family) of psychotic disorder
- •long-term treatment (antidepressant, antipsychotic, thymoregulator) or specific intervention for BDP introduced in the previous four weeks
- •current prescription of MAOIs
结局指标
主要结局
Our primary outcome measures the difference of BPD symptoms’s intensity at BSL-23 (self-rated scale) from baseline to D9
Our primary outcome measures the difference of BPD symptoms’s intensity at BSL-23 (self-rated scale) from baseline to D9
次要结局
- Difference in the intensity of BPD symptoms measured by the BSL-23 scale between baseline and different times (H48, M1, M3)
- Difference in the intensity of BPD symptoms measured by the Zanarini-BPD scale between baseline and different times (H48, D9, M1, M3)
- Difference in the intensity of suicidal ideation measured by the C-SSRS scale between baseline and different times (H48, D9, M1, M3)
- Difference in the intensity of depressive symptoms measured by the MADRS scale between baseline and different times (H48, D9, M1, M3)
- a. Number of new hospitalizations in Psychiatry department (declarative measure, from D9 to M3) b. Number of visits to psychiatric emergencies (declarative measure, from D9 to M3)
- Collection of all serious and non-serious adverse events, in particular those attributed to ketamine
研究者
Dr Gaël GALLIOT
Scientific
Centre Hospitalier Universitaire De Toulouse
研究点 (1)
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