Infusion of Ketamine in Severe Borderline Personality DisorderBorderline Personality Disorder (BPD)
Investigational drug(s) / intervention(s)
IV Ketamine (0.5 mg/kg) Infusion - Two Doses Administered 24 Hours Apart for Severe Borderline Personality Disorder
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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion 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
* 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
Primary outcome measure(s)
Change in Borderline Personality Disorder Symptom Severity (BSL-23) from Baseline (H0) to Day 9 (J9) — 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.
Trial sites (1)
Facility
City
Region
Status
Toulouse Purpan University Hospital, Head of Psychiatry Clinic in the UF3 department
Toulouse
France
More University Hospital, Toulouse trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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