KETAMINE HYDROCHLORIDE for Borderline personality disorder

Inclusion criteria

• {"criterion_text":"- Adult patient aged 18 to 65\n- Free, informed and written consent\n- Fluency in French\n- Diagnosis of borderline personality disorder according to DSM5 MINI criteria (5 out of 9 criteria)\n- Severe borderline personality disorder: BSL-23 score > or= 1.9 (“high” symptoms severity)\n- Patient having a background pharmacological treatment (antipsychotic, mood stabilizer, anti-depressant) and/or non-pharmacological (schema therapy, DBT) stable for four weeks\n- Person affiliated to or beneficiary of a social security system."}

Exclusion criteria

• {"criterion_text":"- lifetime diagnosis or episode of psychotic disorder for the participant or for a first degree relative\n- Protection measure for property and the person in progress (protection of justice, curatorship, guardianship)\n- Pregnant or breastfeeding woman\n- History of a manic or hypomanic episode\n- current severe depressive episode: MADRS > 35 before inclusion\n- ketamine abuse (ketamine taken several times a week)\n- Family history (first degree family) of psychotic disorder\n- long-term treatment (antidepressant, antipsychotic, thymoregulator) or specific intervention for BDP introduced in the previous four weeks\n- current prescription of MAOIs\n- 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)\n- Major ECG abnormality (corrected QT > 450 ms; ST segment abnormalities)\n- Cirrhosis or history of major disturbance in liver function tests (AST or ALT >2N or bilirubin >1,5 N)\n- hepatic or cutaneous porphyria\n- Participation in another interventional study involving humans or being in the exclusion period following previous research if applicable\n- Any reason clinically significant at inclusion baseline wich in the opinion of the investigator could compromise the safety of the participant"}

Primary endpoints

• {"endpoint_text":"- Our primary outcome measures the difference of BPD symptoms’s intensity at BSL-23 (self-rated scale) from baseline to D9","definition_or_measurement_approach":"Difference in BSL-23 (self-rated) score between baseline (H0) and Day 9."}

Secondary endpoints

• {"endpoint_text":"- Difference in the intensity of BPD symptoms measured by the BSL-23 scale between baseline and different times (H48, M1, M3)","definition_or_measurement_approach":"Change in BSL-23 (self-rated) between baseline and H48, M1, M3."}
• {"endpoint_text":"- Difference in the intensity of BPD symptoms measured by the Zanarini-BPD scale between baseline and different times (H48, D9, M1, M3)","definition_or_measurement_approach":"Change in Zanarini-BPD (hetero-evaluative) between baseline and H48, D9, M1, M3."}
• {"endpoint_text":"- Difference in the intensity of suicidal ideation measured by the C-SSRS scale between baseline and different times (H48, D9, M1, M3)","definition_or_measurement_approach":"Change in C-SSRS scores between baseline and H48, D9, M1, M3."}
• {"endpoint_text":"- Difference in the intensity of depressive symptoms measured by the MADRS scale between baseline and different times (H48, D9, M1, M3)","definition_or_measurement_approach":"Change in MADRS scores between baseline and H48, D9, M1, M3."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Count of new psychiatric hospitalizations and emergency psychiatric visits reported between Day 9 and Month 3 (declarative measures)."}
• {"endpoint_text":"- Collection of all serious and non-serious adverse events, in particular those attributed to ketamine","definition_or_measurement_approach":"Recording and collection of all serious and non-serious adverse events throughout study, with specific attribution details for events related to ketamine."}

France

Earliest CTIS Part Ii Submission Date

16-09-2024

Latest Decision Or Authorization Date

28-11-2025

Processing Time Days

438

Number Of Sites

1

Number Of Participants

38

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Toulouse

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France