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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 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 147 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03185819
The ClinicalTrials.gov registry entry for NCT03185819 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 147 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Midazolam is the first listed.
NCT03185819 reports 0 study locations.
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.
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