A Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression (SUSTAIN-2)
Open-label, multicentre, single-group Phase III study (n=802) assessing long-term safety and efficacy of intranasal esketamine plus an oral antidepressant in adults with treatment-resistant depression.
Details
This open-label, multicentre study evaluated long-term safety and efficacy of intranasal esketamine administered with an oral antidepressant in adults with treatment-resistant depression (TRD).
Study design comprised screening (4 weeks), open-label induction (4 weeks), optimisation/maintenance (48 weeks) and follow-up (4 weeks); participants entered directly or were transferred from a prior double-blind induction study.
Esketamine was self-administered intranasally in a flexible regimen (induction twice-weekly: typically 56 or 84 mg for <65 yrs; ≥65 yrs start 28 mg), then reduced to weekly and individualised; safety and depressive symptoms were monitored throughout.