NCT07099534

Ketamine Infusion for Symptomatic Improvement in Severe Borderline Personality Disorder

Ketamine Infusion for Symptomatic Improvement in Severe Borderline Personality Disorder: A Pilot Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Borderline personality disorder is a burden for patient's life and remains undertreated, no medication has FDA or AMM approval for this indication. On a neurobiological level, BPD is thought to involve defects in the regulation of the glutamatergic pathway, as well as circuit anomalies in the emotional pathways (limbic hyperactivation and deficient activation of the prefrontal cortex), which have been associated with impulsivity and emotional hyper-reactivity. Ketamine, an NMDA antagonist, has a pharmacological profile of interest for TPB, thanks to its excitatory action on the CPF and its inhibitory effect on limbic hyperactivity. Preliminary clinical data suggest an effect on TPB symptomatology, more data is needed to conduct a large scale study. This pilot study aim to test the effect of two infusions of ketamine (0,5 mg/kg) in adults with severe BPD. The protocol consists of two IV ketamine injections over 40 min at a dose of 0.5 mg/kg each, at H0 and H24.The associated treatment will be in line with first-level recommendations, i.e. GPM-type psychotherapy. Infusions are delivered under medical monitoring at hospital and patients are followed up to 3 months by regular psychiatric consultations. Change in BPD symptoms'intensity is measured by the scale BSL-23 at different times (baseline, H48, J9, J28, M3) up to 3 months. Suicidal ideations, depressive symptoms, health care sue and adverse effects are also monitored.

Conditions

• Infusion of Ketamine in Severe Borderline Personality Disorder
• Borderline Personality Disorder (BPD)

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2025-11-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-08-01
• Last updated: 2025-08-11

Locations

1 site across 1 country: France