drugset / Trial / NCT07227454
A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to evaluate how well JNJ-54135419 works (efficacy) in addition to comprehensive standard of care (SoC) in rapidly reducing the symptoms of major depressive disorder (MDD, a mental disorder characterized by a persistent feeling of sadness and loss of interest in activities) as compared with psychoactive placebo (does not contain JNJ-54135419) plus SoC in adolescent participants with acute suicidal ideation or behavior.
Timeline
- Start
- 2026-01-08
- Primary completion
- 2031-04-09
- Completion
- 2031-09-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Esketamine | Other / unclassified | 56 mg | Intranasal |
| Subject | Esketamine | Other / unclassified | 84 mg | Intranasal |
| Comparator | Midazolam | Small molecule | 0.0625 mg/kg | Oral |