A Double-blind, Randomized, Psychoactive Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine 84 mg in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder in Adolescent Participants with Acute Suicidal Ideation or Behavior
Phase 3 – large-scale trial before approval
Conditions:
Major Depressive Disorder
Sponsor: Janssen Cilag International
trial.available_in:
БГ
Overview
Trial status: Authorised
Change from baseline (Day 1, predose) at 24 hours post first dose in depressive symptoms, as measured by the CDRS-R total score
Who can participate
Age group: 0-17 years
Gender: Female, Male
Target enrollment: 96 participants
БГ