An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression (SUSTAIN-2) | C4C

Approximately 30% of patients with Major depressive Disorder (MDD) fail to achieve remission despite treatment, and are considered to have Treatment Resistant Depression (TRD). This study is an open-label multicenter, long-term Phase III trial evaluating the safety and efficacy of an investigational treatment for TRD – intranasal esketamine, in addition to a newly initiated course of antidepressants in patients with TRD. This study consists of 4 phases: (i) up to 4-week screening phase; (ii) a 4-week open-label induction phase; (iii) a 48-week open-label optimization/maintenance phase; and (iv) a 4-week follow-up phase. This is a commercial trial sponsored by Janssen. Our site is one of the many international sites for this trial. We will use CRIS for recruitment purposes only.