RecruitingPhase 3ketamine
A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
Sponsored by Janssen Research & Development, LLC
NCT ID
NCT07227454
Target Enrollment
258 participants
Start Date
2026-01-08
Est. Completion
2031-09-15
About This Study
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 Studied
Interventions
- •Esketamine
- •Midazolam
- •Oral Placebo
- •Intranasal Placebo
Eligibility
Age:12 Years - 17 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: * Must meet diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnostic criteria for major depressive disorder (MDD) based upon clinical assessment and confirmed by the mini-international neuropsychiatric interview for children and adolescents (MINI-KID) * Must have a clinical global impression - severity of suicidality - revised (CGI-SS-R) score of "Markedly" or greater (that is, greater than or equal to \[\>=\] 4) at both screening and baseline (predose) visits * Must have a children's depression rating scale - revised (CDRS-R) total score \>= 58 at baseline (predose) * In the physician's opinion, acute psychiatric hospitalization is clinically warranted due to subject's acute suicidality * Must be medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening Exclusion Criteria: * Participant has a current DSM-5 diagnosis of bipolar (or related disorders), intellectual disability, autism spectrum disorder, conduct disorder, oppositional defiant disorder * Participant currently meets DSM-5 criteria for borderline personality disorder * Participant has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychosis * Participant has a history of seizure disorder * Participant has known allergies, hypersensitivity, intolerance or contraindications to midazolam, esketamine or ketamine, or their excipients
Study Locations (27)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Peachford Hospital-Atlanta Behavioral Research
Atlanta, Georgia, United States
University of Cincinnati
Cincinnati, Ohio, United States
Bradley Hospital
East Providence, Rhode Island, United States
Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose
Criciúma, Brazil
Instituto Apice
Salvador, Brazil
Centro Integrado Facili
São Bernardo do Campo, Brazil
Instituto de Pesquisa Pensi Sandra Mutarelli Setubal
São Paulo, Brazil
Fundacao Faculdade de Medicina Hospital da Clinicas da Faculdade de Medicina de Sao Paulo
São Paulo, Brazil
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary
+17 more locations