Ketamine With Dialectical Behavioural Therapy (DBT) for Suicidality in Individuals With Treatment-Resistant Depression and Borderline Personality Disorder (KET-DBT)

Sponsor
Joshua Rosenblat
Study ID
NCT07569198
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Bipolar Disorder (BD)
  • Bipolar Disorder I or II
  • Borderline Personality Disorder (BPD)
  • Major Depressive Disorder (MDD)
  • Suicidal Ideation
  • Treatment-Resistant Major Depressive Disorder
  • Treatment-resistant Bipolar Depression

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Ketamine Hydrochloride — DRUG
    Participants in this arm will receive six ketamine hydrochloride infusions over a month, with doses ranging between 0.5 mg/kg to 0.85 mg/kg
  • Midazolam Hydrochloride — DRUG
    Participants in this arm will receive six midazolam hydrochloride infusions over a month, with doses ranging between 0.02 mg/kg to 0.035 mg/kg
  • Dialectical Behavioral Therapy (DBT) — BEHAVIORAL
    All participants in this trial will receive DBT over six months. Eligible participants will begin with weekly individual sessions, followed by the addition of weekly group sessions beginning in week 5 of the trial.

Study Details

The goal of this clinical trial is to learn if intravenous (IV) ketamine with Dialectical Behavioural Therapy (DBT) reduces suicidal ideation in individuals with suicidality who have been diagnosed with Borderline Personality Disorder and either Major Depressive Disorder or Bipolar Disorder. The main question it aims to answer is: Does IV ketamine and DBT produce more rapid and robust improvements in suicidal ideation (SI) severity between baseline and Day 35 compared to IV midazolam and DBT, as measured by changes in the Modified Scale for Suicidal Ideation (MSSI) scores ? Researchers will compare six IV ketamine infusions and DBT to an active placebo (a look-alike substance that mimics some of ketamine's effects and not others) and DBT to see if IV ketamine with DBT is more effective at reducing SI severity. Participants will: * Complete six infusions of either IV ketamine or IV midazolam * Take part in 6 months of DBT (includes both weekly one-on-one sessions, and group sessions, starting week 5 of the trial) * Visit the hospital for scheduled in-person visits * Join a call or videocall for scheduled remote visits * Complete a variety of different mood, cognitive and behavioral assessments

Key Dates

First listed
May 6, 2026
Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Jan 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ketamine and Dialectical Behavioural Therapy
    All participants in the trial will receive DBT. DBT will begin prior to ketamine infusions and will continue for 6 months of the trial. There will be individual DBT and also group DBT that will begin in Week 5 of the trial. Participants in this arm will receive six infusions of ketamine over a month. The first two infusions will be dosed at 0.5mg/kg over a period of 40 minutes. For infusions 3 and 4, patients will be flexibly dosed between 0.5 mg/kg to 0.75 mg/kg, depending on clinical response to first two infusions. For infusions 5 and 6, participants will be flexibly dosed between 0.5 mg/kg to 0.85 mg/kg.
  • Placebo Comparator: Midazolam and Dialectical Behavioural Therapy
    All participants in the trial will receive DBT. DBT will begin prior to midazolam infusions and will continue for 6 months of the trial. There will be individual DBT and also group DBT that will begin in Week 5 of the trial. Participants in this arm will receive six infusions of midazolam over a month. The first two infusions will be dosed at 0.02 mg/kg over a period of 40 minutes. For infusions 3 and 4, patients will be flexibly dosed between 0.02 mg/kg to 0.03 mg/kg, depending on clinical response to first two infusions. For infusions 5 and 6, participants will be flexibly dosed between 0.2 mg/kg to 0.035 mg/kg.

Primary Outcome Measure

Change in suicidal ideation severity using the Modified Scale for Suicidal Ideation (MSSI) [ Time Frame: From Baseline to Day 35 (Primary Endpoint) ]

Central Contacts

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