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

ConditionsBorderline 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

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-70

SponsorJoshua Rosenblat

About 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

Eligibility criteria

Qualifiers

Adults between the age of 18 to 70, inclusive;

Meets criteria for BPD, as determined by clinical assessment by a psychiatrist or psychologist and confirmed by the International Personality Disorder Examination (IPDE);

Meets DSM-5 criteria for MDD or BD (I or II), currently experiencing a MDE without psychotic features, as diagnosed by a study psychiatrist or psychologist. Diagnosis will be confirmed using the Mini- International Neuropsychiatric Interview (MINI);

Current MDE must be moderate to severe, as determined by the MADRS score >20 with an inadequate response to two or more guideline-concordant treatment trials as defined by the Antidepressant Treatment History Form-Short Form (ATHF- SF);

Disqualifiers

Past or current history of a psychotic disorder as determined by clinical assessment and MINI;

Current or recent (within the past 3 months) manic or hypomanic episode as determined by clinical assessment via YMRS (score > 12) and the MINI;

Meeting criteria for Moderate to Severe Alcohol or substance use disorders currently or within the past 3 months;

Lifetime history of ketamine use disorder or illicit ketamine use.

Trial design

Treatments tested in this trial

Ketamine Hydrochloride
Midazolam Hydrochloride
Dialectical Behavioral Therapy (DBT)

Treatment groups

120 Participants

are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Joshua Rosenblat

Lead sponsor

University Health Network, Toronto

Sponsor institution

Source ClinicalTrials.gov