Ketamine Infusion for Symptomatic Improvement in Severe Borderline Personality Disorder

NCT ID: NCT07099534

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2027-12-31

Brief 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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IV Ketamine Double Infusion (0.5 mg/kg) for Severe Borderline Personality Disorder

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Toulouse, , France

Countries

France

Central Contacts

Gaël Galliot

Role: CONTACT

galliot.g@chu-toulouse.fr

+33 (0)5 34 55 76 51 ext. 33

Facility Contacts

Gaël Galliot

Role: primary

galliot.g@chu-toulouse.fr

+33 (0)5 34 55 76 51 ext. 33

Other Identifiers

2024-514361-19-00

Identifier Type: CTIS

Identifier Source: secondary_id

RC31/23/0619

Identifier Type: -

Identifier Source: org_study_id