Phase III SCAPE-TRD study of Spravato shows improved remission in major depressive disorder.- Janssen Pharma

Data show that adults with treatment-resistant major depressive disorder (TRD) treated with esketamine NS achieved significantly higher remission rates from Week 6 and response rates as early as Day 15 in the study, and at every subsequent time-point through Week 32, compared to adults treated with quetiapine extended-release (XR), when both were dosed as per their respective labels and used in combination with a continuing selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI). The findings were presented at the 31st European Congress of Psychiatry (EPA 2023) taking place from March 25 to March 28 in Paris, France, following earlier top line data from the study presented at the German Association for Psychiatry, Psychotherapy and Psychosomatics (DGPPN) Congress last year.

ESCAPE-TRD is a long-term, comparative, randomised, open-label, rater-blinded phase IIIb clinical study designed to evaluate the short- and long-term efficacy, safety and tolerability of flexibly-dosed esketamine NS compared with quetiapine XR, both in combination with a continuing SSRI or SNRI, in adults with TRD. The study evaluated 676 adults aged 18-74 years with TRD, randomised to receive either esketamine NS (n=336) or quetiapine XR (n=340), both in combination with a continuing SSRI/SNRI. TRD was defined as non-response to at least two consecutive adequately dosed treatments (including the ongoing treatment) during the current depressive episode.

Findings presented at EPA 2023 showed that a significantly higher proportion of participants in the esketamine NS arm achieved remission from Week 6 and at every subsequent time-point through Week 32 compared to the quetiapine XR arm. At Week 32, 55 percent of patients in the esketamine NS arm achieved remission compared to 37 percent in the quetiapine XR arm. In addition, a significantly greater proportion of participants in the esketamine NS arm versus the quetiapine XR arm experienced response§ from Day 15 and at every subsequent time-point through Week 32. Notably, the absolute response rate at Week 8 in the esketamine NS arm was 55.4 percent vs 39.1 percent for quetiapine XR, rising to 75.5 percent vs 55.5 percent respectively at Week 32.

Participants in the esketamine NS study arm also experienced a significantly improved reduction of depressive symptoms, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) vs quetiapine XR from Day 8, with an average difference over time in the least squares (LS) means total MADRS score change from baseline of ?2.4.1 MADRS is a clinician?rated measure of depression severity. Safety findings demonstrated that the rate of treatment discontinuation due to treatment-emergent adverse events (TEAEs) were lower in the esketamine NS arm (4.2 percent versus the quetiapine XR arm (11.0 percent).