Evaluating the Positioning of Esketamine Treatment (PoET) for symptom management in adults with major depressive disorder

Single-arm, uncontrolled phase IV naturalistic study (n=162) evaluating intranasal esketamine (initial 56 mg; subsequent 56 or 84 mg) administered under supervision in the CADE clinic across three treatment phases: acute (weeks 1–4), maintenance (weeks 5–8) and continuation (weeks 9–25). Primary outcome is proportion of treatment responders (≥50% reduction in HAM-D-17).

Dosing schedule: twice weekly in weeks 1–4, once weekly in weeks 5–8, then weekly/fortnightly/monthly as clinically indicated during weeks 9–25. Assessments at baseline and after each administration; dose adjustments performed by the study psychiatrist based on tolerability and response.