Investigating the Efficacy and Pharmacokinetic Profiles of Esketamine at Various Doses for Adolescents with Depression and Suicidal Ideation

This parallel Phase 4 interventional trial in China (n=180) is evaluating the efficacy and pharmacokinetic profiles of esketamine at different doses in adolescents aged 13 to 17 years with depression and suicidal ideation. Participants are allocated to one of three intravenous esketamine groups or a saline control group: low-dose esketamine hydrochloride 0.25 mg/kg, medium-dose 0.375 mg/kg, or high-dose 0.50 mg/kg, each diluted in 50 ml of 0.9% sodium chloride injection and administered by intravenous infusion, versus 50 ml of 0.9% sodium chloride injection alone. The primary outcomes are suicide risk and ideation, measured using the Columbia Suicide Severity Rating Scale (C-SSRS) and the Scale for Suicide Ideation (SSI), with assessment timepoints not specified in the available record. Secondary outcomes include depressive symptoms, anxiety, diagnostic status, cognitive and global functioning, dissociative and manic symptoms, and neuroimaging, assessed using instruments such as the MADRS, HAMA, SCID, CDI, BPRS, YMRS, CADSS, GAF, cognitive testing, and MRI. The study is sponsored by the Affiliated Brain Hospital of Guangzhou Medical University.