Ketamine versus Ketamine plus Behavioural Activation Therapy for Adults with Treatment Resistant Depression
Randomised, parallel-group trial (n=60) comparing oral ketamine plus Behavioural Activation Therapy (BAT) vs oral ketamine plus treatment as usual in adults with treatment-resistant major depressive disorder; oral ketamine initial 0.5 mg/kg (up to 2 mg/kg) sipped over 30–60 minutes.
Details
This parallel, randomised interventional trial enrolls adults with treatment‑resistant major depressive disorder to receive oral ketamine with either a structured Behavioural Activation Therapy programme or treatment as usual; ketamine dosing begins at 0.5 mg/kg (oral, diluted and sipped) with potential escalation to 1.5 and 2 mg/kg based on MADRS and tolerability.
BAT comprises 12 sessions (twice-weekly for 4 weeks then weekly for 4 weeks), timed within 24 hours of ketamine treatments, and is adapted (including He Puna Whakaata principles for Māori). Feasibility, retention, acceptability, depressive symptoms, and cognitive outcomes (MATRICS battery at baseline and 7 days post‑ketamine treatment) will be assessed.