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A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder

RecruitingPhase 3Ages 12 Years - 17 YearsAllJanssen Research & Development, LLC
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to evaluate how well JNJ-54135419 works (efficacy) in addition to comprehensive standard of care (SoC) in rapidly reducing the symptoms of major depressive disorder (MDD, a mental disorder characterized by a persistent feeling of sadness and loss of interest in activities) as compared with psychoactive placebo (does not contain JNJ-54135419) plus SoC in adolescent participants with acute suicidal ideation or behavior.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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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What it tests

  • Esketamine
  • Midazolam
  • Oral Placebo
  • Intranasal Placebo
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Where

44 sites
University of Alabama at Birmingham
Birmingham, United States
Children's National Medical Center
Washington D.C., United States
Peachford Hospital-Atlanta Behavioral Research
Atlanta, United States
Endeavor Health Evanston Hospital
Evanston, United States
Johns Hopkins University
Baltimore, United States
Boston Childrens Hospital
Boston, United States
Mayo Clinic
Rochester, United States
University of Cincinnati
Cincinnati, United States

โ€ฆand 36 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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