Tests esketamine nasal spray for depression in teens with suicidal thoughts
Tests intranasal esketamine with standard care in adolescents with major depression and suicidal thoughts.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
Key facts
- Where
- Bucharest, Cluj-Napoca, Sibiu, and Timișoara, RomaniaSee the 4 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 17 years old?
Source: NCT07227454, who can take part
Where in Romania
- Spitalul Clinic de Psihiatrie Prof Dr Alexandru ObregiaBucharest, RomaniaTaking people
- Spitalul Clinic de Urgenta pentru Copii Cluj NapocaCluj-Napoca, RomaniaTaking people
- Spitalul Clinic De Psihiatrie Dr. Gheorghe Preda SibiuSibiu, RomaniaTaking people
- Spitalul Clinic de Urgenta pentru Copii Louis Turcanu TimisoaraTimișoara, RomaniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Research & Development, LLC
- Trial code
- NCT07227454EU 2024-518615-19-00
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Participant has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychosis; 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 history of seizure disorder; Participant has known allergies, hypersensitivity, intolerance or contraindications to midazolam, esketamine or ketamine, or their excipients.