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NCT03185819 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 147
- Enrollment target
NCT03185819: Completed Phase 2 study, sponsored by Janssen Research & Development.
NCT03185819 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 147 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03185819, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 147 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The CDRS-R is a validated 17- item, clinician-rated instrument developed to assess depressive symptomatology in children. Scores were based on interviews with both the child and their caregiver. Of the 17-item, 3 items were non-verbal behavior (listless speech, hypoactivity, and depressed affect) rated on a 5-point scale from 1 (no depression) to 5 (severe depression) and 14 items were rated on a 7-point scale from 1 (no depression) to 7 (severe depression), where higher score indicated more sev
Interventions
- DRUG Midazolam
- DRUG Esketamine
- DRUG Intranasal Placebo
- DRUG Midazolam Placebo Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2017-10-05 |
| Est. Completion | 2023-03-31 |
| Phase | Phase 2 |
What the finished NCT03185819 record still lists
NCT03185819 is an interventional study that assigns participants to a tested intervention. The registered 147 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher).
The record links to 0 conditions, and to 4 interventions - of which Midazolam is the first listed.
NCT03185819 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03185819 about?
NCT03185819 is a clinical study titled "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". 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 idea...
What is the current status of trial NCT03185819?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 147 participants. The study started on 2017-10-05. Estimated completion is 2023-03-31.
What interventions are being tested in trial NCT03185819?
The interventions under investigation include: Midazolam (DRUG), Esketamine (DRUG), Intranasal Placebo (DRUG), Midazolam Placebo Solution (DRUG).
Who is sponsoring clinical trial NCT03185819?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03185819's enrollment target sits among peer trials
147 495th of 2000 higher than 1,505 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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