Clinical TrialBorderline Personality Disorder (BPD)KetamineNot yet recruiting

Ketamine Infusion for Symptomatic Improvement in Severe Borderline Personality Disorder: A Pilot Study (BorderKET)

Open-label, single-group Phase II pilot (n=38) testing two IV ketamine infusions (0.5 mg/kg each, 40 min, at H0 and H24) plus Good Psychiatric Management in adults with severe BPD; primary outcome at day 9 (BSL-23).

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Target Enrollment
38 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

This pilot evaluates change in BPD symptom severity (BSL-23) at day 9 after two intravenous ketamine infusions (0.5 mg/kg over 40 minutes at H0 and H24) delivered alongside Good Psychiatric Management.

Participants are monitored for suicidal ideation, depressive symptoms, healthcare use, and adverse events with follow-up visits through three months; vital signs and AEs are assessed around each infusion.

Study Protocol

Preparation

sessions

Dosing

2 sessions
40 min each

Integration

sessions

Therapeutic Protocol

support

Study Arms & Interventions

IV ketamine

experimental

Two intravenous ketamine infusions (0.5 mg/kg each) at H0 and H24, 40-minute infusion; delivered with standard-of-care Good Psychiatric Management.

Interventions

  • Ketamine0.5 mg/kg
    via IV• two infusions, 24 hours apart• 2 doses total

    Each infusion over 40 minutes; vitals and AEs monitored.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion 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

  • 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 a monoamine oxidase inhibitor
  • Specific absolute contraindication to ketamine
  • History of cirrhosis or major liver function test abnormalities
  • Major ECG abnormality

Study Protocol, Arms & Participants

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Study Details

Study Team

Sponsors & Collaborators

Locations

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

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