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.
Key facts
- Who runs it
- Janssen Research & Development, LLC
- Where
- Bolzano, Cagliari, Catania, Florence, Foggia, Genoa, Naples, and Sassari, ItalySee the 8 sitesAlso in 6 other countries, 41 sites
- Trial code
- Registry title
- A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 258 people, planned
- Started
- 8 Jan 2026
- Expected to end
- 15 Sept 2031
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Esketamine
- Midazolam
- Oral Placebo
- Intranasal Placebo
- Record updated
- 3 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for teenagers with major depressive disorder who have acute suicidal thoughts or behavior and need hospital care. It tests intranasal esketamine added to standard care.
- Age
- 12 to 17 years
- Sex
- All sexes can join.
- Disease stage
- Major depressive disorder (MDD) confirmed by an interview (MINI-KID). Suicidality score of "Markedly" or greater (4 or more) at screening and baseline. Depression rating score (CDRS-R) of 58 or more at baseline. A doctor must judge that urgent hospital care for psychiatric reasons is needed because of suicidal thoughts.
Main reasons for not taking part
- Bipolar or related disorders, intellectual disability, autism spectrum disorder, conduct disorder or oppositional defiant disorder
- Borderline personality disorder
- Current or past psychotic disorder, or depression with psychosis
- History of seizure disorder
- Known allergy or intolerance to midazolam, esketamine or ketamine
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
Where in Italy
Also in 6 other countries, 41 sites
- Azienda Sanitaria Dell'Alto AdigeBolzano, ItalyTaking people
- ARNAS G. BrotzuCagliari, ItalyTaking people
- Azienda Sanitaria Provinciale Di CataniaCatania, ItalyTaking people
- Azienda Ospedaliera Universitaria Meyer IRCCSFlorence, ItalyTaking people
- Azienda Ospedaliero Universitaria Ospedali RiunitiFoggia, ItalyTaking people
- IRCCS Istituto Giannina GasliniGenoa, ItalyTaking people
- Azienda Ospedaliera Universitaria Federico II Di NapoliNaples, ItalyTaking people
- Azienda Ospedaliero-Universitaria di SassariSassari, ItalyTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Intranasal Esketamine + Oral PlaceboTreatment being tested
Participants will receive intranasal esketamine 84 milligrams (mg) along with oral placebo solution twice weekly for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25). On Day 4 a decrease to intranasal esketamine 56 mg (in a blinded fashion per investigator's judgment) is permitted. Thereafter, dose may be flexed between 56 mg and 84 mg during the treatment period.
Treatment: Esketamine and Oral Placebo
- Intranasal Placebo + Oral MidazolamPlacebo, for comparison
Participants will receive oral midazolam (0.0625 milligrams per kilograms \[mg/kg\]) and intranasal placebo twice weekly for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25). On Day 4 a sham decrease to esketamine 56 mg dose (in a blinded fashion per investigator's judgment) is permitted. Thereafter, sham dose may be flexed between 56 mg and 84 mg during the treatment period.
Treatment: Midazolam and Intranasal Placebo
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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-language title
- Tests esketamine nasal spray for depression in teens with suicidal thoughtsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07227454, who can take part
- Record updated
- 3 November 2026