Effectiveness, safety and acceptability of Intra-Nasal Esketamine: evidence from a real-world cohort study
Abstract
This study examines the real-world effectiveness, safety and acceptability of intranasal esketamine in individuals with treatment-resistant depression (TRD). Given the limited “real world” evidence on esketamine, particularly in patients with more severe forms of TRD and its distinct mechanism of action compared to traditional antidepressants, this study aims to expand the evidence base by systematically evaluating both short-term and long-term treatment outcomes. Data are being collected from patients treated at all participating esketamine treatment centers across the Netherlands, which collaborate in the Esketamine Nasal-spray Consortium Netherlands (ENC-NL). The study employs an unblinded, open-label cohort design. Eligible participants are adults aged 18 years or older who meet criteria for TRD, defined as an inadequate response to at least two antidepressant regimens administered at adequate dosages for a minimum duration of six weeks. In the Netherlands, reimbursement of intranasal esketamine requires not only failure of two antidepressants, but also failure of at least one augmentation strategy (at sufficient dosages for a minimum duration), during the current episode. Therefore we will mostly include patients with a higher level of TRD than investigated in the registration studies. The intervention consists of esketamine nasal spray administered at dosages between 28 and 84 mg per session, given twice weekly for four weeks, as an adjunct to a standard antidepressant. Those considered responders based on clinical judgement, symptom reduction based on MADRS/ IDS-SR scores and after shared decision making proceed to an optimalisation and thereafter maintenance phase, starting with once-weekly sessions for four weeks, followed by a gradual tapering of treatment frequency when possible. The primary outcome measure is the change in Montgomery-Åsberg Depression Rating Scale (MADRS) scores from baseline. Secondary outcomes include changes in self-reported depressive symptoms (IDS-SR), quality of life (EQ-5D-5L), daily functioning (WHODAS), side effects (SEs) as measured by the Ketamine Side Effect Tool (KSET), and rates of treatment discontinuation.
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