Not Yet RecruitingPhase 2ketamine

Ketamine Infusion for Symptomatic Improvement in Severe Borderline Personality Disorder

NCT ID

NCT07099534

Target Enrollment

38 participants

Start Date

2025-11-01

Est. Completion

2027-12-31

About This Study

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.

Conditions Studied

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

Interventions

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

Eligibility

Age:18 Years - 65 Years

Healthy Volunteers:No

View full eligibility criteria

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

Study Locations (1)

Toulouse Purpan University Hospital, Head of Psychiatry Clinic in the UF3 department

Toulouse, France