Ketamine Infusion for Symptomatic Improvement in Severe Borderline Personality Disorder

NCT07099534 | Not Yet Recruiting Phase 2

• 2 other identifiers: RC31/23/06192024-514361-19-00
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Ketamine; borderline personality disorder; BDP

Outcome Measures

Primary Outcomes (1)

• Change in Borderline Personality Disorder Symptom Severity (BSL-23) from Baseline (H0) to Day 9 (J9)

  The primary outcome measure is the change in symptom severity of Borderline Personality Disorder (BPD) as assessed by the Borderline Symptom List-23 (BSL-23) from Baseline to Day 9 post perfusion. The BSL-23 is a self-reported scale measuring BPD symptom intensity, with scores ranging from 0 (no symptoms) to 92 (most severe symptoms). A higher score indicates greater symptom severity. The difference in total BSL-23 scores between Baseline and Day 9 will be analyzed to evaluate the short-term impact of IV ketamine treatment on BPD symptoms.

  Baseline and Day 9 post perfusion

Secondary Outcomes (5)

• Change in Borderline Personality Disorder Symptom Severity (BSL-23) from Baseline to H48, Month 1 (M1), and Month 3 (M3)

  Baseline, 48 hours, 1 month, and 3 months after first ketamine infusion.

• Change in Borderline Personality Disorder Symptom Severity Measured by Zanarini-BPD Scale from Baseline to H48, D9, M1, and M3

  Baseline, 48 hours, Day 9, 1 month, and 3 months after first ketamine infusion.

• Change in Suicidal Ideation Severity Measured by C-SSRS from Baseline to H48, D9, M1, and M3

  Baseline, 48 hours, Day 9, 1 month, and 3 months after first ketamine infusion.

• Change in Depressive Symptom Severity Measured by MADRS from Baseline to H48, D9, M1, and M3

  Baseline, 48 hours, Day 9, 1 month, and 3 months after first ketamine infusion.

• Number of Psychiatric Emergency Room Visits (Self-Reported, Day 9 to Month 3)

  From Day 9 (J9) to Month 3 (M3)

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

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

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Gaël Galliot

CONTACT

+33 (0)5 34 55 76 51; galliot.g@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 1, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)