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CompletedNCT03185819

Intranasal Esketamine for Imminent Suicide Risk in Adolescents

About this title

Study to Evaluate the Efficacy and Safety of 3 Fixed Doses 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 Participants Assessed to be at Imminent Risk for Suicide

Read the official source — NCT03185819

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

Medication studyAges 9–17Multiple countries
The study in practice

Understand this study

What did researchers investigate?

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

Who was this study for?

Listed age limits: 9 years to 17 years.

Listed locations
Hartford and 50 more locationsSee all locations and recruitment
Study phase
Phase 2Usually explores whether the intervention may work, while continuing to monitor safety.

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Study clarity

Study information

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
Show the full 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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Recruitment & locations

Completed

Hartford, United States · New Haven, United States · Atlanta, United States

44 more locations
  • Chicago, United States
  • Winfield, United States
  • South Bend, United States
  • Iowa City, United States
  • Lake Charles, United States
  • Baltimore, United States
  • Gaithersburg, United States
  • Buffalo, United States
  • Chapel Hill, United States
  • Winston-Salem, United States
  • Cincinnati, United States
  • Cleveland, United States
  • Columbus, United States
  • Nashville, United States
  • Dallas, United States
  • Brussels, Belgium
  • Curitiba, Brazil
  • Salvador, Brazil
  • São Bernardo do Campo, Brazil
  • Turvo, Brazil
  • Rousse, Bulgaria
  • Varna, Bulgaria
  • Bron, France
  • Lille, France
  • Nantes, France
  • Paris, France
  • Budapest, Hungary
  • Szeged, Hungary
  • Cagliari, Italy
  • Foggia, Italy
  • Merano, Italy
  • Messina, Italy
  • Naples, Italy
  • Pavia, Italy
  • Trieste, Italy
  • Krakow, Poland
  • Warsaw, Poland
  • Barcelona, Spain
  • Esplugues de Llobregat, Spain
  • Madrid, Spain
  • Majadahonda, Spain
  • Oviedo, Spain
  • Pamplona, Spain
  • Sabadell, Spain
FAQ

Questions about this study

What did researchers investigate?

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

Who is behind this study?

The study sponsor is Janssen Research & Development, LLC.

Did this study involve medication?

Yes. The study involved medication, including Intranasal Placebo, Midazolam Placebo Solution, Midazolam and Esketamine.

Who was this study for?

Listed age limits: 9 years to 17 years.

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