Objective: Phase 3 trials have demonstrated the efficacy and safety of esketamine nasal spray (ESK) plus a newly initiated oral antidepressant (AD) for treatment-resistant depression (TRD). This analysis examined the impact of individual ADs (duloxetine, escitalopram, sertraline, venlafaxine XR) or AD class (selective serotonin reuptake inhibitors [SSRIs] or serotonin and norepinephrine reuptake inhibitors [SNRIs]) on outcomes.
Methods: This post hoc analysis of pooled data from two phase 3 ESK trials (TRANSFORM-1, NCT02417064; TRANSFORM-2, NCT02418585) assessed mean change from baseline to day 28 in Montgomery–Åsberg Depression Rating Scale (MADRS) total score, and proportion of patients exhibiting response and remission. Safety assessments included treatment-emergent adverse events. Efficacy and safety endpoints were analyzed by individual AD/AD class. Subgroup differences were examined using ANCOVA models or Cochran-Mantel-Haenzsel tests.
Results: Overall, 343 patients were included in the analyses. Mean change (SE) in MADRS total score at day 28 was -19.9 (0.8) with ESK+AD and was similar by individual AD/AD class. Overall, 58.7% and 42.2% of patients met criteria for response and remission, respectively. Response rates at day 28 were similar by individual ADs (duloxetine [n=138], 60.1%; escitalopram [n=63], 61.9%; sertraline [n=55], 49.0%, venlafaxine XR [n=54], 61.1%) and AD class (SSRI [n=118], 55.9%; SNRI [n=192], 60.4%). The overall rate of TEAEs was similar by concomitant individual AD/AD class.
Conclusion: Subgroup analyses from two phase 3 ESK trials in TRD showed no major differences in MADRS total score changes at day 28, response and remission rates, or rate of overall TEAEs by concomitant individual AD/AD class.
This poster was presented at the 32nd annual Psych Congress, held Oct. 3-6, 2019, in San Diego, California.