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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: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT03097133 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 230 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
MADRS is clinician-rated scale designed to be used in participants with Major Depressive Disorder (MDD) to measure depression severity and detect changes due to antidepressant treatment. It evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic and suicidal thoughts. Scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms), summed for total
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 |
What the finished NCT03097133 record still lists
NCT03097133 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03097133 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03097133's enrollment target sits among peer trials
230 1304th of 2000 higher than 692 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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