Evaluating Intranasal Esketamine with Standard Care to Reduce Symptoms and Suicidal Thoughts in Adolescents with Major Depressive Disorder

What this Trial Is About

Researchers are evaluating how well intranasal esketamine works alongside standard care to quickly reduce symptoms of major depressive disorder MDD in adolescents aged 12 to 17 who experience acute suicidal thoughts or behaviors. This Phase 3 study compares esketamine plus standard care with a psychoactive placebo plus standard care to assess symptom improvement in this vulnerable population. Participants receive either intranasal esketamine 84 mg twice weekly for 4 weeks with a possible dose reduction to 56 mg, or oral midazolam plus intranasal placebo with similar dosing schedules. The treatment period includes dosing on Days 1, 4, 8, 11, 15, 18, 22, and 25, with dose flexibility based on investigator judgment. This double-blind, randomized trial involves two groups receiving either the experimental or placebo regimen. During the study, participants are monitored through clinical assessments including the Childrens Depression Rating Scale - Revised CDRS-R at baseline and 24 hours after the first dose, among other measures of depressive symptoms and suicidality throughout the 25-day treatment. Safety is assessed via medical exams, vital signs, and ECG. The primary outcome focuses on depressive symptom changes within 24 hours, with secondary outcomes tracking symptom progression, remission, and suicidality severity during treatment.

A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder