A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder (NCT07227454)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 12 Years to 17 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (39 Sites)
Showing the first 25 of 39 sites.
- University of Alabama at Birmingham — Birmingham, Alabama
- Children's National Medical Center — Washington D.C., District of Columbia
- Peachford Hospital-Atlanta Behavioral Research — Atlanta, Georgia
- Endeavor Health Evanston Hospital — Evanston, Illinois
- Johns Hopkins University — Baltimore, Maryland
- Boston Childrens Hospital — Boston, Massachusetts
- Mayo Clinic — Rochester, Minnesota
- University of Cincinnati — Cincinnati, Ohio
- Bradley Hospital — East Providence, Rhode Island
- John S Dunn Behavioral Sciences Center at UTHealth Houston — Houston, Texas
- Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose — Criciúma,
- Universidade Federal do Rio Grande do Norte Hospital Universitario Onofre Lopes — Natal,
- Instituto Apice — Salvador,
- Centro Integrado Facili — São Bernardo do Campo,
- Instituto de Pesquisa Pensi Sandra Mutarelli Setubal — São Paulo,
- Hospital Das Clinicas Da Faculdade De Medicina Da USP — São Paulo,
- Debreceni Egyetem Klinikai Kozpont — Debrecen,
- Petz Aladar Megyei Oktato Korhaz — Győr,
- Szegedi Tudomanyegyetem — Szeged,
- Presidio Ospedaliero Santa Marta e Santa Venera — Acireale,
- Azienda Ospedaliera G. Brotzu — Cagliari,
- AOU Meyer — Florence,
- Azienda Ospedaliera Universitaria Policlinico Riuniti di Foggia — Foggia,
- Azienda Ospedaliera Universitaria Federico II — Naples,
- Azienda Ospedaliero Universitaria di Sassari — Sassari,
📞 Contact the Study Coordinator
Phone: (844) 434-4210
Email: Participate-In-This-Study1@its.jnj.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Depressive Disorder, Major
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- Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab — Boston, Massachusetts
- bWell-D Pilot Randomized Controlled Trial — Vancouver, British Columbia
- Pharmaco-Neuroimaging Studies of Approach/Avoidance Behaviors and Post-Mortem Studies: Pharmacological Manipulation — Belmont, Massachusetts
- Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms — Birmingham, Alabama
Explore by condition: All Depressive Disorder, Major clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.