Ketamine Infusion for Symptomatic Improvement in Severe Borderline Personality Disorder (BorderKET)

Toulouse University Hospital

Status and phase

Not yet enrolling

Phase 2

Conditions

Infusion of Ketamine in Severe Borderline Personality Disorder

Borderline Personality Disorder (BPD)

Treatments

Drug: IV Ketamine (0.5 mg/kg) Infusion - Two Doses Administered 24 Hours Apart for Severe Borderline Personality Disorder

Study type

Interventional

Funder types

Other

Identifiers

NCT07099534

2024-514361-19-00 (EU Trial (CTIS) Number)

RC31/23/0619

Details and patient eligibility

About

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.

Full 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.

Enrollment

38 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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