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

Summary

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

Conditions

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

Interventions

DRUG

Ketamine Hydrochloride

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

DRUG

Midazolam Hydrochloride

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

BEHAVIORAL

Dialectical Behavioral Therapy (DBT)

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.

Sponsors & Collaborators

• Joshua Rosenblat

  lead OTHER

Principal Investigators

• Joshua D. Rosenblat, MD, MSc · Toronto Western Hospital, Psychiatry

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-01

Primary Completion

2029-01-31

Completion

2029-08-31