BridgeMD
Ketamine infusion for symptomatological improvement of severe borderline personality disorder: a pilot study
EU CTIS ID: 2024-514361-19-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 > or= 1.9 (“high” symptoms severity)
- Patient having a background pharmacological treatment (antipsychotic, mood stabilizer, anti-depressant) and/or non-pharmacological (schema therapy, DBT) stable for four weeks
You likely can't join if
- 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
See the full eligibility criteria
- 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 > or= 1.9 (“high” symptoms severity)
- 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.
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.