i-CBT and IV Ketamine for Suicidality in Treatment-Resistant Depression: A Randomized, Midazolam-Controlled Clinical Trial (Ket-CBT)
Phase II, randomised, quadruple-blind trial (n=110) comparing i-CBT plus six IV ketamine infusions versus i-CBT plus six IV midazolam infusions to reduce suicidality in treatment-resistant depression.
Details
Background: Suicide is a leading cause of death among young people; novel scalable interventions are needed. i-CBT is accessible but not rapidly effective for suicidality, whereas IV ketamine produces rapid reductions in suicidal thoughts.
Design: A 13-week, multi-site randomized parallel-group trial; all participants receive weekly i-CBT for 13 weeks and are randomised to six IV ketamine infusions (flexible 0.5–0.85 mg/kg) or six IV midazolam infusions (0.02–0.035 mg/kg) over the first 30 days. Primary endpoint at day 30 with follow-up to day 91.