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.
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)
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
Single group
IV Ketamine (0.5 mg/kg) Infusion - Two Doses Administered 24 Hours Apart for Severe Borderline Personality Disorder
DrugParticipants 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.
Change in Borderline Personality Disorder Symptom Severity (BSL-23) from Baseline (H0) to Day 9 (J9)
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 to H48, Month 1 (M1), and Month 3 (M3)
This secondary outcome measure evaluates changes in symptom severity of Borderline Personality Disorder (BPD) using the Borderline Symptom List-23 (BSL-23) at multiple time points: H48, Month 1 (M1), and Month 3 (M3), compared to Baseline. The BSL-23 is a self-reported scale assessing BPD symptoms, with total scores ranging from 0 (no symptoms) to 92 (most severe symptoms). Higher scores indicate greater symptom severity. The difference in scores across these time points will be analyzed to assess the medium- to long-term impact of IV ketamine treatment on BPD symptoms.
Change in Borderline Personality Disorder Symptom Severity Measured by Zanarini-BPD Scale from Baseline to H48, D9, M1, and M3
The Zanarini-BPD scale assesses the severity of borderline personality disorder symptoms based on nine DSM-IV criteria. Each criterion is rated on a Likert scale from 0 to 4, with higher scores indicating greater symptom severity. The total score ranges from 0 to 36. This outcome measures the change in symptom severity from baseline to H48, D9, M1, and M3.
Change in Suicidal Ideation Severity Measured by C-SSRS from Baseline to H48, D9, M1, and M3
The Columbia-Suicide Severity Rating Scale (C-SSRS) assesses suicidal ideation severity based on structured interview questions. Scores range from 0 (no suicidal ideation) to 5 (active suicidal intent with a plan). This outcome measures changes in severity from baseline to H48, D9, M1, and M3.
Change in Depressive Symptom Severity Measured by MADRS from Baseline to H48, D9, M1, and M3
The Montgomery-Åsberg Depression Rating Scale (MADRS) assesses the severity of depressive symptoms based on a structured clinical interview. The scale includes 10 items, each rated from 0 (no symptoms) to 6 (severe symptoms), with a total score ranging from 0 to 60. Higher scores indicate more severe depression. This outcome measures changes in depressive symptom severity from baseline to H48, D9, M1, and M3.
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