This interventional trial (n=56) will evaluate the effects of combined intranasal esketamine and brief cognitive behavioural therapy for suicide prevention (BCBT-SP) in patients experiencing suicidal ideation associated with treatment-resistant depression (TRD). The primary aim is to assess reductions in suicidal ideation at one week post-treatment, comparing the combined treatment group with a control group receiving only intranasal esketamine. Participants aged 18 to 70 with a major depressive episode and ongoing suicidal ideation will be recruited. The trial will consist of two arms: one receiving naturalistic intranasal esketamine and the other receiving BCBT-SP alongside intranasal esketamine, involving 12 weekly sessions of psychotherapy. Key outcome measures include the Beck Scale for Suicidal Ideation and TMS-EEG N100 peak, both assessed one week after treatment. The study is set to begin in January 2026 and is expected to complete by January 2029.
The purpose of this study is to examine the effects of combined intranasal esketamine with brief cognitive behavioral therapy for suicide prevention (BCBT-SP) for suicidal ideation (SI) in patients with treatment- resistant depression (TRD). The secondary aim is to identify the biological targets of treatment response using combined transcranial magnetic stimulation and electroencephalography (TMS-EEG). In this project we will recruit patients between the ages of 18 and 70, diagnosed with a major depressive episode with ongoing suicidal ideation present who have failed (or not shown signs of improvement) after at least one prior treatment. The null hypothesis is that there will be no difference in reductions in suicidality at 1-week post-treatment between the combined treatment group and the ketamine only treatment group. The alternative hypothesis is that the combined treatment will result in a greater reduction in suicidal ideation at 1-week post-treatment.
Naturalistic Intranasal Esketamine
Brief Cognitive Behavioral Therapy for Suicide Prevention combined with Intranasal Esketamine
Unmatched intervention: Brief Cognitive Behavioral Therapy for Suicide Prevention