i-CBT and IV Ketamine for Suicidality in Treatment-Resistant Depression: A Randomized, Midazolam-Controlled Clinical Trial (Ket-CBT)

This phase II, randomised, midazolam-controlled clinical trial (n=110) will evaluate the effectiveness of combining internet-based cognitive behavioural therapy (i-CBT) with intravenous ketamine in reducing suicidality in individuals with treatment-resistant depression.

The study, sponsored by the University Health Network in Toronto, aims to address the urgent need for effective treatments for suicidality in major depressive disorder.

Participants will undergo weekly i-CBT sessions for 13 weeks. Over the first 30 days, they will be randomly assigned to receive either six intravenous infusions of ketamine or midazolam (the control).

The trial will measure changes in suicidality and depressive symptoms before treatment, at the 30-day mark, and after 3 months. The study also includes assessments of cognitive function, well-being, and potential adverse effects.

The research is being conducted at Toronto General Hospital and Ontario Shores Centre for Mental Health Sciences, with an expected completion in July 2025.

Trial Details

Approximately four thousand Canadians die by suicide every year, and suicide is the second leading cause of death in youth and young adults (15-34 years). Most people with depression experience thoughts of suicide and many will also plan and/or attempt suicide at some time in their life. There is an urgent need for new scalable treatments that can effectively reduce suicidality in people with depression. Cognitive behavioural therapy (CBT) reduces suicidal thoughts and behaviours, and can be delivered through the internet (i-CBT) making it more accessible and scalable. However, i-CBT has not been shown to rapidly reduce suicidal thoughts and behaviours (suicidality), such as within 24 hours. IV ketamine on the other hand has been shown to rapidly reduce thoughts of suicide, but not suicidal behaviours. Therefore, combining i-CBT with IV ketamine may be more effective reducing suicidality than i-CBT treatment with a control treatment. The investigators propose a 13-week, multi-site, study that looks at how combining i-CBT and IV ketamine treatment will affect suicidality in individuals with depression who have recently experienced suicidal thoughts and/or behaviours, but have not responded to previous treatment. All 110 participants will receive a weekly session of i-CBT for 13 weeks, but half will be randomly assigned to also receive six IV ketamine treatments or six IV midazolam treatments (control treatment) over the first initial 30 days. The investigators will measure changes in suicidal thoughts and behaviours before drug treatment and at the primary endpoint (i.e.,day 30), and after 3 months (i.e. Day 91) of the starting treatment.

NCT Number NCT06480500

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