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NCT03097133 · ClinicalTrials.gov registry record · Phase 3
54135419SUI3002: A Study to Evaluate the Efficacy and Safety 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 Adult Participants Assessed to be at Imminent Risk for Suicide
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 230
- Enrollment target
NCT03097133 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 230 participants.
The verdict
NCT03097133, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 230 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of intranasal esketamine 84 milligram (mg) compared with intranasal placebo in addition to comprehensive standard of care in reducing the symptoms of Major Depressive Disorder (MDD), including suicidal ideation, in participants who are assessed to be at imminent risk for suicide, as measured by the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 24 hours post first dose.
Interventions
- DRUG Placebo
- OTHER Standard of Care
- DRUG Esketamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2017-06-15 |
| Est. Completion | 2019-04-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03097133
The ClinicalTrials.gov registry entry for NCT03097133 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 230 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 3 interventions - of which Placebo is the first listed.
NCT03097133 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03097133 about?
NCT03097133 is a clinical study titled "54135419SUI3002: A Study to Evaluate the Efficacy and Safety 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 Adult Participants Assessed to be at Imminent Risk for Suicide". The purpose of this study is to evaluate the efficacy of intranasal esketamine 84 milligram (mg) compared with intranasal placebo in addition to comprehensive standard of care in reducing the symptoms of Major Depressive Disorder (MDD), including suicidal ideation, in participants who are assessed t...
What is the current status of trial NCT03097133?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 230 participants. The study started on 2017-06-15. Estimated completion is 2019-04-11.
What interventions are being tested in trial NCT03097133?
The interventions under investigation include: Placebo (DRUG), Standard of Care (OTHER), Esketamine (DRUG).
Who is sponsoring clinical trial NCT03097133?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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