Clinical TrialCompleted
A Study to Evaluate the Efficacy and Safety of Esketamine Combined With Oral Antidepressants in the Treatment of Major Depressive Disorder With Suicidal Ideation
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.
Target Enrollment
100 participants
Study Type
Phase IV interventional
Design
Randomized, double Blind
Registry
Study Details
- StatusCompleted
- PhasePhase IV
- Typeinterventional
- DesignRandomizeddouble Blind
- Target Enrollment100 participants
- TimelineStart: 2021-01-01