Ketamine + DBT for Suicidal Thoughts
(KET-DBT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Who Is on the Research Team?
Joshua D. Rosenblat, MD, MSc
Principal Investigator
Toronto Western Hospital, Psychiatry
Are You a Good Fit for This Trial?
This trial is for adults aged 18-70 who have Borderline Personality Disorder and are currently experiencing moderate to severe depression or bipolar depression, with ongoing suicidal thoughts. They must not have responded well to at least two previous treatments and should have stable medication and therapy for the past month.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Dialectical Behavioral Therapy (DBT)
- Ketamine Hydrochloride
Trial Overview
The study compares six IV infusions of ketamine plus Dialectical Behavioral Therapy (DBT) over six months versus midazolam (an active placebo) plus DBT, to see which combination better reduces suicidal thoughts in people with treatment-resistant depression and BPD.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Joshua Rosenblat
Lead Sponsor
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