Actively Recruiting
A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
258
Participants Needed
9
Research Sites
296 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must meet DSM-5 criteria for major depressive disorder confirmed by clinical assessment and MINI-KID
- Must have a Clinical Global Impression - Severity of Suicidality - Revised (CGI-SS-R) score of 4 or higher at screening and baseline
- Must have a Children's Depression Rating Scale - Revised (CDRS-R) total score of 58 or more at baseline
- Acute psychiatric hospitalization is clinically warranted due to acute suicidality
- Must be medically stable based on physical exam, medical history, vital signs, and ECG at screening
You will not qualify if you...
- Current DSM-5 diagnosis of bipolar or related disorders, intellectual disability, autism spectrum disorder, conduct disorder, or oppositional defiant disorder
- Current diagnosis of borderline personality disorder
- Current or past DSM-5 diagnosis of psychotic disorder or major depressive disorder with psychosis
- History of seizure disorder
- Known allergies or intolerance to midazolam, esketamine, ketamine, or their components
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 9 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Peachford Hospital-Atlanta Behavioral Research
Atlanta, Georgia, United States, 30338
Actively Recruiting
3
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
4
Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose
Criciúma, Brazil, 88811 000
Actively Recruiting
5
Instituto Apice
Salvador, Brazil, 40170 108
Actively Recruiting
6
Centro Integrado Facili
São Bernardo do Campo, Brazil, 09726 150
Actively Recruiting
7
Petz Aladar Megyei Oktato Korhaz
Győr, Hungary, 9023
Actively Recruiting
8
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Actively Recruiting
9
Tri-Service General Hospital
Taipei, Taiwan, 114
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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