A Long-Term Extension Study for Participants With Treatment-resistant Major Depressive Disorder Who Are Continuing Esketamine Nasal Spray Treatment
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.
Details
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.