Randomised, parallel-arm trial (n=6 actual) comparing concurrent behavioural activation therapy plus intranasal esketamine versus esketamine alone for treatment-resistant depressive episodes in MDD or BD.
This single-site, parallel-arm randomized clinical trial tests whether combining behavioural activation therapy with intranasal esketamine produces larger, faster, and more sustained reductions in depressive symptoms than esketamine alone.
Esketamine is administered intranasally with an induction phase (twice weekly for 4 weeks) followed by maintenance (once weekly or biweekly) for a total treatment period of 12 weeks; BA therapy consists of 12 weekly one-hour sessions delivered virtually or in person.
Primary outcomes assess depressive symptom change and speed of antidepressant response; secondary outcomes include functional recovery measures and treatment feasibility in a naturalistic academic-hospital setting.
Concurrent intranasal esketamine plus weekly behavioural activation therapy (BA) for 12 sessions.
Behavioural Activation (BA) therapy: 12 one-hour sessions, virtual or in person; delivered on a non-esketamine dosing day.
Intranasal esketamine — induction twice weekly for 4 weeks (usually 56 mg Day 1 then 56 or 84 mg), maintenance up to week 12.
Intranasal esketamine as treatment as usual; BA offered after week 12.
Intranasal esketamine per standard clinical care (induction then maintenance).