A Study to Evaluate the Efficacy and Safety of Intranasal Esketamine 84 mg Plus Standard Care for Rapid Symptom Reduction in Adolescents With Major Depressive Disorder and Acute Suicidal Behavior

What this Trial Is About

Researchers are evaluating the efficacy and safety of intranasal esketamine combined with comprehensive standard care to rapidly reduce symptoms of major depressive disorder (MDD) in adolescents aged 12 to 17 years who have acute suicidal thoughts or behavior. This study compares esketamine plus standard care with a psychoactive placebo plus standard care to understand its effect on depressive symptoms and suicidality in this vulnerable population. Participants are randomly assigned to one of two groups. One group receives intranasal esketamine (starting at 84 mg, with possible dose adjustment to 56 mg) plus an oral placebo twice weekly for 4 weeks. The other group receives oral midazolam plus intranasal placebo on the same schedule. Dose adjustments between 56 mg and 84 mg are allowed based on investigator judgment. Treatment is delivered during visits on specific days over the 25-day treatment period. During the study, participants undergo assessments including the Children's Depression Rating Scale-Revised (CDRS-R) and Clinical Global Impression of suicidality, measured at baseline and throughout treatment. Researchers monitor changes in depressive symptoms, suicidality severity, and patient-reported outcomes. The primary outcome focuses on symptom change 24 hours after the first dose. Safety and efficacy are evaluated through day 25, with all visits and monitoring scheduled throughout the study period.

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