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RecruitingNCT07227454

Esketamine with usual care for depression and suicidal thoughts in teens

About this titleRead the official source — NCT07227454

This study evaluates the safety and effectiveness of Esketamine for people with depression.

Medication studyAges 12–17Multiple countries
The study in practice

Understand this study

What is this study about?

This study evaluates the safety and effectiveness of Esketamine for people with depression.

Who could participate?

Listed age limits: 12 years to 17 years.

Listed locations
Birmingham and 43 more locationsSee all locations and recruitment
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.

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What to know before participating

A point to clarify

This summary does not cover all risks or eligibility requirements. What risks or changes to my care would apply to me?

Study clarity

Things to check before joining

Study start dateStarted: January 8, 2026
Recruitment status
Recruiting
Enrollment listed in the registry
258
Sponsor
Janssen Research & Development, LLC
Sponsor type
Other organization
Study type
Drug
Intervention type
Medication / drug, OTHER
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Locations
United States, Brazil, Hungary, ...
Age range
From 12 Years to 17 Years
Official registry ID
NCT07227454
Official title
Show the full 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

Recruitment & locations

Recruiting

Birmingham, United States · New Haven, United States · Washington D.C., United States

40 more locations
  • Atlanta, United States
  • Evanston, United States
  • Baltimore, United States
  • Boston, United States
  • Rochester, United States
  • Chapel Hill, United States
  • Cincinnati, United States
  • East Providence, United States
  • Houston, United States
  • Criciúma, Brazil
  • Natal, Brazil
  • Salvador, Brazil
  • São Bernardo do Campo, Brazil
  • São Paulo, Brazil
  • Budapest, Hungary
  • Debrecen, Hungary
  • Győr, Hungary
  • Szeged, Hungary
  • Acireale, Italy
  • Cagliari, Italy
  • Florence, Italy
  • Foggia, Italy
  • Genova, Italy
  • Merano, Italy
  • Naples, Italy
  • Sassari, Italy
  • Bucharest, Romania
  • Cluj-Napoca, Romania
  • Sibiu, Romania
  • Timișoara, Romania
  • Barcelona, Spain
  • Esplugues de Llobregat, Spain
  • Madrid, Spain
  • Manresa, Spain
  • Oviedo, Spain
  • Pamplona, Spain
  • Sabadell, Spain
  • Santander, Spain
  • New Taipei City, Taiwan
  • Taipei, Taiwan

A listed location does not confirm current availability.

FAQ

Questions about this study

What is this study about?

This study evaluates the safety and effectiveness of Esketamine for people with depression.

Who is behind this study?

The study sponsor is Janssen Research & Development, LLC.

Does this study involve medication?

Yes. The study involves medication, including Esketamine and Midazolam.

Who can participate?

Listed age limits: 12 years to 17 years.

Is this study still recruiting?

The registry lists this study as recruiting.

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