SAN DIEGO— Two phase 3 trials presented during a poster session at Psych Congress 2019 found that, esketamine nasal spray, added to standard-of-care treatment, rapidly reduced depressive symptoms in patients at immediate risk of suicide.
Studies, ASPIRE-1 and ASPIRE-2, randomized adults with severe depression who had active suicidal ideation with intent and who also required psychiatric hospitalization, to 84 mg of esketamine nasal spray twice a week or placebo for four weeks.
In ASPIRE-1, 113 patients received esketamine nasal spray and 112 patients received placebo. At baseline, the average total score on the Montgomery-Ǻsberg Depression Rating Scale (MADRS) was 41.1. On the Clinical Global Impression-Severity of Suicidal—Revised (CGI-SS-R) scale, 89% of patients rated moderately to extremely suicidal.
Twenty-four hours after the first dose, patients who received esketamine showed significant improvement in MADRS total score, compared with patients who received placebo.
In ASPIRE-2, 114 patients were randomized to esketamine nasal spray and 113 to placebo. Baseline average MADRS total score was 39.7, and 91% of patients rated moderately to extremely suicidal on the CGI-SS-R scale. Similar to ASPIRE-1, in only 24 hours after the first dose, patients who received esketamine demonstrated significant improvement in MADRS total score, when compared with patients who received placebo.
Common adverse events with esketamine were dizziness, dissociation, and nausea.
Everyone who participated was highly monitored for safety and also received comprehensive standard-of-care treatment during the trial.
Janssen Research & Development sponsored ASPIRE-1 and ASPIRE-2