Esketamine Quickly Reduces Depressive Symptoms in Patients at Risk of Suicide

SAN DIEGO—Added to standard-of-care treatment, esketamine nasal spray rapidly reduced depressive symptoms in patients at imminent risk of suicide, according to two placebo-controlled, phase 3 trials presented during a poster session at Psych Congress 2019.

The studies, named ASPIRE-1 and ASPIRE-2, randomized adults with major depressive disorder who had active suicidal ideation with intent and required psychiatric hospitalization, to 84 mg of esketamine nasal spray twice a week or placebo over 4 weeks. All participants also received comprehensive standard-of-care treatment and were monitored for safety during the trial.

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, and 89% of patients rated moderately to extremely suicidal on the Clinical Global Impression–Severity of Suicidality–Revised (CGI-SS-R) scale. Twenty-four hours after the first dose, patients who received esketamine showed significant improvement in MADRS total score, compared with patients who received placebo.

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Similarly, ASPIRE-2 randomized 114 patients 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. Again, 24 hours after the first dose, patients who received esketamine demonstrated significant improvement in MADRS total score, compared with those who received placebo, according to the poster abstract.

In both studies, CGI-SS-R scores improved but did not differ significantly between the two treatment groups. Common adverse events with esketamine were dizziness, dissociation, and nausea.

Janssen Research & Development sponsored the studies.

—Jolynn Tumolo

References

Fu DJ, Canuso C, Ionescu DF, et al. Esketamine nasal spray for rapid reduction of major depressive disorder symptoms in adult patients at imminent risk for suicide: ASPIRE-1, a phase 3 randomized study. Poster presented at Psych Congress 2019; October 3-6, 2019; San Diego, CA. Poster 138.

Ionescu DF, Canuso C, Fu DJ, et al. Esketamine nasal spray for rapid reduction of major depressive disorder symptoms in adult patients at imminent risk for suicide: ASPIRE-2, a phase 3 randomized study. Poster presented at Psych Congress 2019; October 3-6, 2019; San Diego, CA. Poster 151.