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Clinical Trials in the EU / 2024-518615-19-00
Ongoing Phase III

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

2024-518615-19-00 · tracked via the Priya Life Science EU tracker
Sponsor
Janssen Cilag International
Sponsor type
Pharmaceutical company
Therapeutic area
Mental Disorders
Decision date
19/11/2025
Enrollment target
96
Sites
Italy, Hungary, Spain, Romania

Condition studied

Major Depressive Disorder

Investigational medicinal product(s)

Spravato 28 mg nasal spraysolutionMidazolam-ratiopharm® 2 mg/ml orale LösungOral placeboIntranasal Placebo

Eligibility

Age group
0-17 years
Sex
Female, Male

Primary endpoint

Change from baseline (Day 1, predose) at 24 hours post first dose in depressive symptoms, as measured by the CDRS-R total score

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2024-518615-19-00 on CTIS ↗ ← All trials in the EU