Last updated on August 2020

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

Brief description of study

The purpose of this study is to assess the efficacy of a single (first) dose of 3 fixed doses of intranasal esketamine {28 milligram (mg), 56 mg, and 84 mg} compared with psychoactive placebo (oral midazolam) in rapidly reducing the symptoms of major depressive disorder (MDD) including suicidal ideation in participants 12 to less than 18 years of age who are assessed to be at imminent risk for suicide.

Detailed Study Description

This study will enroll participants with major depressive disorder (MDD) presenting with suicidal ideation who are assessed to be at imminent risk for suicide. The study will be conducted in 4 phases: a screening evaluation performed within 48 hours prior to Day 1 intranasal dose; a 25-day double-blind treatment phase (Days 1-25); an 8week initial post-treatment phase (Days 25-81); and a subsequent phase to complete a full 6month post-treatment follow-up (Days 81-200). Efficacy, safety, pharmacokinetic, biomarker, and pharmacogenomic evaluations will be performed in the study at defined schedule. The duration of the participant's participation will be approximately 29 weeks. If you or a loved one are having thoughts of suicide, please seek immediate medical help. Go to the emergency room or call the National Suicide Prevention Lifeline at 1-800-273-8255.

Clinical Study Identifier: NCT03185819

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Yale University

New Haven, CT United States
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SIU School of Medicine

Springfield, IL United States
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Lake Charles Clinical Trials

Lake Charles, LA United States
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Sheppard Pratt Health System

Baltimore, MD United States
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Wake Forest Baptist Medical Center

Winston-Salem, NC United States
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Ohio State University

Columbus, OH United States
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Tennessee State University

Johnson City, TN United States
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Hopital Erasme

Brussels, Belgium
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CHU Nantes

Nantes, France
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CHU Saint-etienne

Saint-Priest-En-Jarez, France
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Hosp. Sant Joan de Deu

Esplugues de Llobregat, Spain
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Asclepes Research

Panorama City, CA United States
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Rady Children's Hospital

San Diego, CA United States
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Hosp. Sant Joan de Deu

Esplugues De Llobregat, Spain
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Recruitment Status: Open

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