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CompletedNCT03185819

3 Fixed Doses (28 mg, 56 mg and 84 mg) of Intranasal Esketamine for depression

This study is completed in the United States, in France, in Belgium, .... It is testing 3 Fixed Doses (28 mg, 56 mg and 84 mg) of Intranasal Esketamine for depression.

Depression, SuicidalityDrugFrom 9 Years to 17 Years

The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.

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In plain English

Key information made simple

What is this study testing?

This study is testing whether Intranasal Placebo may be useful for children experiencing depression.

What would participation involve?

Participants may receive Intranasal Placebo, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in Belgium, in Brazil, and in Bulgaria.

Who is it mainly for?

This study appears to be mainly for children with depression. Because it involves minors, a parent or guardian may need to be involved.

What should you check before joining?

Ask about the dose, safety monitoring, and possible side effects, whether there is placebo, randomization, or a comparison group, how many visits or travel steps are needed, what role parents or guardians have in the process.

Your next step

Check the study details

Check the official source, then confirm these points with the research team.

View official study record (opens in a new tab)
  • Recruitment and eligibility

    Is a site open, and who can take part?

  • Visits and time

    Where are visits, can any be remote, and how much time is needed?

  • Costs and support

    What costs, reimbursement or compensation apply?

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: October 5, 2017
Recruitment status
Completed
Enrollment listed in the registry
147
Sponsor
Janssen Research & Development, LLC
Sponsor type
Other organization
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 2Usually explores whether the intervention may work, while continuing to monitor safety.
Locations
United States, France, Belgium, ...
Age range
From 9 Years to 17 Years
Official registry ID
NCT03185819
Official title
A Double-blind, Randomized, Psychoactive Placebo-controlled, Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (28 mg, 56 mg and 84 mg) of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Subjects Assessed to be at Imminent Risk for Suicide

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Check recruitment and locations

Recruitment checked against the registry by HopeStage on . Registry information can change. Always confirm availability with the research team.

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The overall study status can differ from each site's status. Open a country to see its locations and their registry status.

Belgium · 1 site
  • Hopital Erasme
    Brussels
    Site status: Not listed — confirm with the team
Brazil · 4 sites
  • Trial Tech Tecnologia em Pesquisas com Medicamentos
    Curitiba
    Site status: Not listed — confirm with the team
  • Hospital Universitario Professor Edgar Santos
    Salvador
    Site status: Not listed — confirm with the team
  • CEMEC - Centro Multidisciplinar de Estudos Clínicos
    São Bernardo do Campo
    Site status: Not listed — confirm with the team
  • Hospital São Sebastião
    Turvo
    Site status: Not listed — confirm with the team
Bulgaria · 2 sites
  • Mental Health Center - Rousse
    Rousse
    Site status: Not listed — confirm with the team
  • Multiprofile Hospital for Active Treatment - MHAT Sveta Marina EAD
    Varna
    Site status: Not listed — confirm with the team
France · 6 sites
  • Hospices Civils de Lyon HCL
    Bron
    Site status: Not listed — confirm with the team
  • CHRU Lille - Hôpital Fontan 1
    Lille
    Site status: Not listed — confirm with the team
  • CHU Nantes
    Nantes
    Site status: Not listed — confirm with the team
  • Hôpital Universitaire Pitié-Salpêtrière
    Paris
    Site status: Not listed — confirm with the team
  • Hopital Sainte Anne
    Paris
    Site status: Not listed — confirm with the team
  • Hôpital Robert Debré
    Paris
    Site status: Not listed — confirm with the team
Hungary · 2 sites
  • Vadaskert Gyermek es Ifjusagpszichiatriai Korhaz es Szakambulancia
    Budapest
    Site status: Not listed — confirm with the team
  • Szegedi Tudomanyegyetem
    Szeged
    Site status: Not listed — confirm with the team
Italy · 7 sites
  • Azienda Ospedaliera G. Brotzu
    Cagliari
    Site status: Not listed — confirm with the team
  • OSP RIUNITI-DIP Donna- Bambino
    Foggia
    Site status: Not listed — confirm with the team
  • Ospedale di Merano
    Merano
    Site status: Not listed — confirm with the team
  • Azienda Ospedaliera Universitaria Policlinico G. Martino
    Messina
    Site status: Not listed — confirm with the team
  • Azienda Ospedaliera Universitaria Federico II
    Naples
    Site status: Not listed — confirm with the team
  • IRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione
    Pavia
    Site status: Not listed — confirm with the team
  • Irccs Burlo-Garofalo
    Trieste
    Site status: Not listed — confirm with the team
Poland · 3 sites
  • Klinika Psychiatrii Dzieci i Mlodziezy, CM UJ
    Krakow
    Site status: Not listed — confirm with the team
  • Dzieciecy Szpital Kliniczny im Jozefa Polikarpa Brudzinskiego
    Warsaw
    Site status: Not listed — confirm with the team
  • Instytut Psychiatrii i Neurologii Klinika Psychiatrii Dzieci i Mlodziezy
    Warsaw
    Site status: Not listed — confirm with the team
Spain · 8 sites
  • Hosp Clinic de Barcelona
    Barcelona
    Site status: Not listed — confirm with the team
  • Hosp. Sant Joan de Deu
    Esplugues de Llobregat
    Site status: Not listed — confirm with the team
  • Hosp. Gral. Univ. Gregorio Maranon
    Madrid
    Site status: Not listed — confirm with the team
  • Hosp. Infantil Univ. Nino Jesus
    Madrid
    Site status: Not listed — confirm with the team
  • Hosp. Univ. Pta. de Hierro Majadahonda
    Majadahonda
    Site status: Not listed — confirm with the team
  • Hosp. Univ. Central de Asturias
    Oviedo
    Site status: Not listed — confirm with the team
  • Clinica Univ. de Navarra
    Pamplona
    Site status: Not listed — confirm with the team
  • Corporacio Sanitari Parc Tauli
    Sabadell
    Site status: Not listed — confirm with the team
United States · 18 sites
  • Institute of Living/ Hartford Hospital
    Hartford, Connecticut
    Site status: Not listed — confirm with the team
  • Yale University
    New Haven, Connecticut
    Site status: Not listed — confirm with the team
  • Atlanta Behavioral Research, LLC
    Atlanta, Georgia
    Site status: Not listed — confirm with the team
  • Rush University Medical Center
    Chicago, Illinois
    Site status: Not listed — confirm with the team
  • Neuroscience Research Institute
    Winfield, Illinois
    Site status: Not listed — confirm with the team
  • Beacon Medical Group Clinical Research
    South Bend, Indiana
    Site status: Not listed — confirm with the team
  • University of Iowa, Carver College of Medicine
    Iowa City, Iowa
    Site status: Not listed — confirm with the team
  • Lake Charles Clinical Trials
    Lake Charles, Louisiana
    Site status: Not listed — confirm with the team
  • Sheppard Pratt Health System
    Baltimore, Maryland
    Site status: Not listed — confirm with the team
  • CBH Health
    Gaithersburg, Maryland
    Site status: Not listed — confirm with the team
  • State University of New York at Buffalo
    Buffalo, New York
    Site status: Not listed — confirm with the team
  • University North Carolina at Chapel Hill
    Chapel Hill, North Carolina
    Site status: Not listed — confirm with the team
  • Wake Forest Baptist Medical Center
    Winston-Salem, North Carolina
    Site status: Not listed — confirm with the team
  • University of Cincinnati Hospital
    Cincinnati, Ohio
    Site status: Not listed — confirm with the team
  • University Hospital of Cleveland
    Cleveland, Ohio
    Site status: Not listed — confirm with the team
  • Ohio State University
    Columbus, Ohio
    Site status: Not listed — confirm with the team
  • Vanderbilt University Medical Center
    Nashville, Tennessee
    Site status: Not listed — confirm with the team
  • University of Texas Southwestern Medical Center
    Dallas, Texas
    Site status: Not listed — confirm with the team
In practice

For you

Participation may contribute to research. Personal benefit is not guaranteed.

Ask the research team to explain the activities, time commitment, and follow-up involved.

Study sites are listed. Confirm the relevant site and any travel before making plans.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

FAQ

Questions about this study

What is this study trying to understand?

This study is exploring medication or study treatment for people with depression. Participants may complete study visits, assessments, or follow-up activities defined by the research team. Direct benefit is not guaranteed. The detailed objective is not always clearly listed in the public registry; the study team can confirm.

Does this study involve a medication?

This appears to be a medication / drug study involving Intranasal Placebo, Midazolam Placebo Solution, Midazolam, Esketamine. Phase 2 studies usually explore whether the intervention may work, while continuing to monitor safety.

Who might this study be for?

This study may concern people with depression; age range: From 9 Years to 17 Years. The criteria appear fairly specific, but you should not assume you are eligible. The study team must confirm diagnosis, age, exclusions, available locations, and next steps.

What would I likely need to do?

You may need to take a study treatment and have regular medical follow-up. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

What side effects, interactions, or treatment changes should I check?

If the study involves a medication, ask whether it is already approved, experimental, or being tested for a new use. Check possible side effects, interactions with current treatment, dose changes, monitoring, and what happens if you feel worse. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by Janssen Research & Development, LLC, which appears to be another type of organization. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.

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