This open-label, Phase II trial (n=38) will assess the effects of intravenous ketamine (35mg/70kg, two infusions 24 hours apart) on symptoms of severe borderline personality disorder (BPD).
The study is sponsored by the University Hospital in Toulouse, France, and will combine ketamine treatment with Good Psychiatric Management (GPM) — a first-line psychotherapy approach for BPD. Ketamine is given via two 40-minute infusions under hospital supervision, at Hour 0 and Hour 24, with participants monitored for safety before, during, and after treatment. The primary aim is to measure changes in BPD symptom severity from baseline to Day 9, using the Borderline Symptom List-23 (BSL-23). Secondary measures include changes in suicidal thoughts, depressive symptoms, and healthcare use, tracked over a 3-month follow-up period.
Eligible participants are adults aged 18–65 with a DSM-5 diagnosis of severe BPD who are receiving stable psychiatric treatment. Exclusions include histories of psychosis, mania, current severe depression, recreational ketamine use, and certain medical conditions. Researchers hope the findings will provide evidence to support larger trials investigating ketamine’s potential as a novel treatment for severe BPD, a condition with limited pharmacological options.
Trial Details
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Sponsors & Collaborators
University Hospital ToulouseThe University Hospital of Toulouse (CHU de Toulouse) is a leading medical institution located in Toulouse, France. It provides comprehensive healthcare services, conducts medical research, and offers educational programs for healthcare professionals