Phase 2 Trial of Ketamine and Dialectical Behavioural Therapy DBT to Reduce Suicidal Thoughts in Adults With Treatment-Resistant Depression and Borderline Personality Disorder

What this Trial Is About

Researchers are evaluating whether intravenous IV ketamine combined with Dialectical Behavioural Therapy DBT reduces suicidal thoughts more effectively than IV midazolam with DBT in individuals diagnosed with Borderline Personality Disorder BPD and either Major Depressive Disorder MDD or Bipolar Disorder BD. The study focuses on whether ketamine and DBT lead to faster and stronger improvements in suicidal ideation severity, measured by the Modified Scale for Suicidal Ideation MSSI from baseline to Day 35. Participants will receive six IV infusions of either ketamine or midazolam over one month, with dosing adjusted based on clinical response. All participants will also take part in DBT for six months, starting with weekly individual sessions and adding weekly group sessions from Week 5. The ketamine doses range from 0.5 mgkg to 0.85 mgkg, while midazolam doses range from 0.02 mgkg to 0.035 mgkg. During the trial, participants will attend scheduled hospital visits and remote calls for assessments including mood, cognitive, and behavioral evaluations. Researchers will measure changes in suicidal ideation and behavior, depression severity, personality symptoms, anxiety, and safety through various scales over six to nine months. Safety and tolerability are monitored throughout the study period, which lasts up to nine months.

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