A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
Purpose
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.
Condition
- Depressive Disorder, Major
Eligibility
- Eligible Ages
- Between 12 Years and 17 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intranasal Esketamine + Oral Placebo |
Participants will receive intranasal esketamine 84 milligrams (mg) along with oral placebo solution twice weekly for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25). On Day 4 a decrease to intranasal esketamine 56 mg (in a blinded fashion per investigator's judgment) is permitted. Thereafter, dose may be flexed between 56 mg and 84 mg during the treatment period. |
|
|
Placebo Comparator Intranasal Placebo + Oral Midazolam |
Participants will receive oral midazolam (0.0625 milligrams per kilograms [mg/kg]) and intranasal placebo twice weekly for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25). On Day 4 a sham decrease to esketamine 56 mg dose (in a blinded fashion per investigator's judgment) is permitted. Thereafter, sham dose may be flexed between 56 mg and 84 mg during the treatment period. |
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Recruiting Locations
University of Alabama at Birmingham
Birmingham, Alabama 35294
Birmingham, Alabama 35294
Peachford Hospital-Atlanta Behavioral Research
Atlanta, Georgia 30338
Atlanta, Georgia 30338
Endeavor Health Evanston Hospital
Evanston, Illinois 60201
Evanston, Illinois 60201
University of Cincinnati
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
Bradley Hospital
East Providence, Rhode Island 02915
East Providence, Rhode Island 02915
John S Dunn Behavioral Sciences Center at UTHealth Houston
Houston, Texas 77021
Houston, Texas 77021
More Details
- Status
- Recruiting
- Sponsor
- Janssen Research & Development, LLC