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Can a ketamine nasal spray quickly ease severe depression in suicidal teens?

NCT ID NCT07227454

Symptom relief Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study tests whether a nasal spray containing esketamine, given alongside standard care, can rapidly reduce symptoms of major depression and suicidal thoughts in adolescents. About 258 teens with acute suicidal ideation or behavior will receive either esketamine or a psychoactive placebo. The main goal is to see if depression scores improve within 24 hours and last through 25 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Esketamine (a nasal spray form of ketamine)
What this could lead to
If it works, this could provide a fast-acting option to ease severe depression and suicidal thoughts in teenagers, potentially saving lives during a crisis.
What could go wrong
This is a Phase 3 trial, but it's still experimental. Esketamine can cause side effects like dizziness, nausea, or dissociation. The placebo used is a psychoactive drug (midazolam), which may complicate results. Success is not guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 258 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Sep 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depressive disorder, major

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    39 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AOU Meyer

    RECRUITING

    Florence, 50134, Italy

  • Azienda Ospedaliera G. Brotzu

    RECRUITING

    Cagliari, 09134, Italy

  • Azienda Ospedaliera Universitaria Federico II

    RECRUITING

    Naples, 80131, Italy

  • Azienda Ospedaliera Universitaria Policlinico Riuniti di Foggia

    RECRUITING

    Foggia, 71122, Italy

  • Azienda Ospedaliero Universitaria di Sassari

    RECRUITING

    Sassari, 07100, Italy

  • Boston Childrens Hospital

    RECRUITING

    Boston, Massachusetts, 02445, United States

  • Bradley Hospital

    RECRUITING

    East Providence, Rhode Island, 02915, United States

  • Centro Integrado Facili

    RECRUITING

    São Bernardo do Campo, 09726 150, Brazil

  • Children's National Medical Center

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Clinica Univ. de Navarra

    RECRUITING

    Pamplona, 31008, Spain

  • Debreceni Egyetem Klinikai Kozpont

    RECRUITING

    Debrecen, 4031, Hungary

  • Endeavor Health Evanston Hospital

    RECRUITING

    Evanston, Illinois, 60201, United States

  • Fundacio Althaia Xarxa Assistencial Universitaria de Manresa

    RECRUITING

    Manresa, 08243, Spain

  • Hosp Univ Vall D Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hosp. Clinic de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hosp. Gral. Univ. Gregorio Maranon

    RECRUITING

    Madrid, 28009, Spain

  • Hosp. Sant Joan de Deu

    RECRUITING

    Esplugues de Llobregat, 08950, Spain

  • Hosp. Univ. Central de Asturias

    RECRUITING

    Oviedo, 33011, Spain

  • Hosp.Univ.Parc Tauli

    RECRUITING

    Sabadell, 08208, Spain

  • Hospital Das Clinicas Da Faculdade De Medicina Da USP

    RECRUITING

    São Paulo, 05403-900, Brazil

  • Instituto Apice

    RECRUITING

    Salvador, 40170 108, Brazil

  • Instituto de Pesquisa Pensi Sandra Mutarelli Setubal

    RECRUITING

    São Paulo, 01 227 200, Brazil

  • John S Dunn Behavioral Sciences Center at UTHealth Houston

    RECRUITING

    Houston, Texas, 77021, United States

  • Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Mackay Memorial Hospital Tamsui Branch

    RECRUITING

    New Taipei City, 251, Taiwan

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 100, Taiwan

  • Peachford Hospital-Atlanta Behavioral Research

    RECRUITING

    Atlanta, Georgia, 30338, United States

  • Petz Aladar Megyei Oktato Korhaz

    RECRUITING

    Győr, 9023, Hungary

  • Presidio Ospedaliero Santa Marta e Santa Venera

    RECRUITING

    Acireale, 95024, Italy

  • Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose

    RECRUITING

    Criciúma, 88811 000, Brazil

  • Spitalul Clinic de Urgenta pentru Copii Cluj Napoca

    RECRUITING

    Cluj-Napoca, 400658, Romania

  • Szegedi Tudomanyegyetem

    RECRUITING

    Szeged, 6720, Hungary

  • Taipei Medical University Hospital

    RECRUITING

    Taipei, 110, Taiwan

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 112, Taiwan

  • Tri-Service General Hospital

    RECRUITING

    Taipei, 114, Taiwan

  • Universidade Federal do Rio Grande do Norte Hospital Universitario Onofre Lopes

    RECRUITING

    Natal, 59012 300, Brazil

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45219, United States

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