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Ketamine Infusion for Symptomatic Improvement in Severe Borderline Personality Disorder

NCT07099534 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-05-12

No results posted yet for this study

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)

Interventions

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.

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-09-30
Completion
2028-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07099534 on ClinicalTrials.gov