This naturalistic, open-label, single-arm intervention trial (n=162) conducted by Royal North Shore Hospital assesses add-on intranasal esketamine (Spravato) for adults with major depressive disorder.
Open-label, single-group study of intranasal esketamine administered under supervision as an add-on to ongoing antidepressant treatment across acute (weeks 1–4), maintenance (weeks 5–8) and continuation (weeks 9–25) phases.
Primary aims are to evaluate effectiveness of esketamine in real-world practice and to identify patient characteristics associated with therapeutic response; participants are observed for two hours after dosing with blood pressure monitoring and complete questionnaires and reassessments for dose adjustment.
Supervised intranasal esketamine administered as add-on to ongoing antidepressant treatment across acute, maintenance and continuation phases with dose adjustments by study psychiatrist.
Intranasal Spravato; initial 56 mg, subsequent 56 mg or 84 mg as clinically indicated; observed 2 hours post-dose with BP monitoring.