Open-label single-group long-term extension (n=183) assessing long-term safety and tolerability of intranasal esketamine plus SSRI/SNRI in participants with treatment-resistant major depressive disorder who completed prior esketamine study.
This single-group, open-label long-term extension evaluates safety and tolerability of esketamine nasal spray administered weekly or every two weeks in combination with an ongoing SSRI/SNRI for up to two years in participants with treatment-resistant major depressive disorder who completed the prior maintenance study.
Assessments focus on adverse events and cardiovascular safety, with investigator-driven dose optimisation of SSRI/SNRI permitted; participants must have been benefiting from continued esketamine treatment and be medically stable at baseline.
Open-label single-group continuation of esketamine nasal spray with ongoing SSRI/SNRI; up to 2 years or until commercial availability.
Self-administered intranasal esketamine per prior study dosing and investigator judgment; dosing adjusted per local SmPC.
Continued SSRI/SNRI (approved agent for depression in country); dose may be optimised or switched for tolerability.