NCT07227454 A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
| NCT ID | NCT07227454 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Janssen Research & Development, LLC |
| Condition | Depressive Disorder, Major |
| Study Type | INTERVENTIONAL |
| Enrollment | 258 participants |
| Start Date | 2026-01-08 |
| Primary Completion | 2031-04-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 258 participants in total. It began in 2026-01-08 with a primary completion date of 2031-04-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07227454 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 17 Years, studying Depressive Disorder, Major. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07227454 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 258 participants.
Is NCT07227454 currently recruiting?
Yes, NCT07227454 is actively recruiting participants. Contact the research team at Participate-In-This-Study1@its.jnj.com for enrollment information.
Where is the NCT07227454 trial being conducted?
This trial is being conducted at Birmingham, United States, Atlanta, United States, Cincinnati, United States, East Providence, United States and 11 additional locations.
Who is sponsoring the NCT07227454 clinical trial?
NCT07227454 is sponsored by Janssen Research & Development, LLC. The trial plans to enroll 258 participants.