A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
Sponsored by Janssen Research & Development, LLC
About this study
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.
Where this study is enrolling (2)
- I'm interested
Peachford Hospital-Atlanta Behavioral Research
Atlanta, Georgia
- Call 847-570-2000
Endeavor Health Evanston Hospital
Evanston, Illinois
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Who can participate
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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Trial data sourced from ClinicalTrials.gov.