Phase 4 randomized parallel-group trial of esketamine (0.25 mg/kg) vs midazolam (0.02 mg/kg) as add-on to oral antidepressants in adolescent and adult patients with MDD and suicidal ideation. Four arms (adolescent/adult × esketamine/midazolam), 25 per arm, 100 total. Primary outcome: Columbia Suicide Severity Rating Scale. Sponsor: Affiliated Brain Hospital of Guangzhou Medical University, China.
3 infusions of esketamine (0.25 mg/kg) administered on days 1, 3, and 5, combined with routine inpatient care and oral antidepressants.
Infused in 50 mL of 0.9% saline over 40 minutes.
3 infusions of midazolam (0.045 mg/kg) administered on days 1, 3, and 5, combined with routine inpatient care and oral antidepressants.
Used as an active control/placebo; infused in 50 mL of 0.9% saline over 40 minutes.
This placebo-controlled trial (n=54) investigates the efficacy and safety of esketamine (iv, 17.5mg, 3x) in adolescents suffering from depression (MDD) and suicidal ideation (SI). It shows significant reductions in Columbia Suicide Severity Rating Scale (C-SSRS) Ideation and Intensity scores and Montgomery-Åsberg Depression Rating Scale (MADRS) scores in the esketamine group compared to the midazolam (placebo) group at day six, with maintained antisuicidal and antidepressant responses at four weeks post-treatment.