A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression (SUSTAIN-3)
Open-label, long-term extension Phase III safety study (n≈1148) of esketamine nasal spray (flexible 28–84 mg dosing) in participants with treatment-resistant depression, induction twice weekly for 4 weeks then individualised maintenance.
Details
This open-label extension evaluates the long-term safety and tolerability of esketamine nasal spray in participants with treatment-resistant depression who rolled over from prior phase trials.
Design includes a 4-week induction phase with twice-weekly flexible dosing (28, 56 or 84 mg depending on age and prior dosing), followed by an optimisation/maintenance phase with weekly or biweekly dosing determined by clinical judgement.
Primary assessments are safety and tolerability measures including adverse events, vital signs, ECG and laboratory monitoring; study enrolled participants from multinational sites.