A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder (ESCAPE-TRD)
This Phase III interventional trial (n=676) evaluated flexibly dosed esketamine nasal spray versus quetiapine XR, both with a continuing SSRI/SNRI, in participants with treatment-resistant major depressive disorder.
Details
Randomized, parallel-group Phase III trial comparing flexibly dosed esketamine nasal spray (28/56/84 mg) plus continuing SSRI/SNRI against quetiapine XR augmentation of SSRI/SNRI in adults with treatment-resistant major depressive disorder.
Treatment included an 8-week acute phase (induction: twice-weekly dosing initially) followed by a 24-week maintenance phase with once-weekly or once-every-2-weeks dosing; safety assessments included AEs/SAEs, vitals, ECG, labs and C-SSRS monitoring.
Primary objective was efficacy for remission in participants with TRD; background SSRI/SNRI was continued and could be optimised per SmPC throughout the study.