A Study to Assess Feasibility of Using Clinician-directed and Digital Application Supported Cognitive Behavior Therapy (CBT) in Conjunction With Esketamine in Participants With Treatment-resistant Depression

This single-group Phase I feasibility study evaluated esketamine nasal spray administered twice weekly for 4 weeks (induction) then weekly for 8 weeks (maintenance) alongside an oral antidepressant, with clinician-directed CBT supplemented by the Mindset app delivered after dosing when participants were judged ready.

Primary aim was feasibility of combining pharmacological treatment and digital-supported psychotherapy in treatment-resistant depression; safety and tolerability assessed per standard clinical measures.