EFFICACY AND SAFETY OF ESKETAMINE NASAL SPRAY IN PATIENTS WITH MAJOR DEPRESSIVE DISORDER AND ACTIVE SUICIDAL IDEATION: RESULTS FROM A RANDOMIZED DOUBLE-BLIND STUDY

Major depressive disorder and the presence of active suicidal ideation is a psychiatric emergency that must be treated swiftly and efficiently. The traditional antidepressants have the disadvantage of slow action that causes an unmet clinical need in acute suicidal crisis. It was a randomized, placebo-controlled, double-blind study, which compared the effectiveness and safety of the esketamine nasal spray in patients with major depressive disorder and intent-to-committ suicide thoughts. One hundred and sixty (160) patients were randomly assigned to take esketamine 84 mg and the standard-of-care or placebo and standard-of-care. The main outcome measure was Montgomery-Aseberg Depression Rating Scale (MADRS) total score at 24 hours of first dose. The secondary endpoints were modifications to the severity of suicidality and safety outcomes. Esketamine was shown to respond with rapid response in the depressive symptoms than that of placebo, with a statistically significant response in terms of suicidality measures. Adverse events emerging during the treatment were high in the esketamine group yet were mostly mild to moderate and temporary. These results justify the use of esketamine as a suitable and convenient rapid-acting intervention, in high-risk patients with depression.