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NCT03039192 · ClinicalTrials.gov registry record · Phase 3
54135419SUI3001: 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 of Depressive Disorder, Major, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 226
- Enrollment target
- 20
- Study locations
NCT03039192 is a Phase 3 study of Depressive Disorder, Major that has completed, run by Janssen Research & Development. The registered enrollment target is 226 participants, roughly in line with the 238-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target. The trial reports 20 study locations across 14 states.
The verdict
NCT03039192, a Phase 3 study of Depressive Disorder, Major, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 226 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the 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.
Conditions Studied
Interventions
- OTHER Placebo
- OTHER Standard of Care
- DRUG Esketamine
Study Locations (20)
Other
- Regional Psychiatric Dispansery - Bulgaria
- Mental Health Center Prof. Dr. Ivan Temkov - Burgas
- State Psychiatric Hospital - Lovech - Lovech
Illinois
- Rush University - Chicago
- Alexian Behavioral Health Hospital - Hoffman Estates
Louisiana
- LSU Health Sciences Center New Orleans - New Orleans
- Louisiana Clinical Research - Shreveport
Maryland
- Sheppard Pratt Health System - Baltimore
- CBH Health - Gaithersburg
New York
- State University of New York - Buffalo
- Columbia University Medical Center - New York
Alabama
- UAB Department of Psychiatry and Behavioral Neurobiology - Birmingham
Arizona
- Metropolitan Neuro Behavioral Institute - Chandler
California
- Collaborative NeuroScience Network - Garden Grove
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 226 participants |
| Start Date | 2017-06-09 |
| Est. Completion | 2018-12-18 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03039192
The ClinicalTrials.gov registry entry for NCT03039192 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 226 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 238-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Depressive Disorder, Major appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03039192 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Other, Illinois, Louisiana.
Frequently Asked Questions
What is clinical trial NCT03039192 about?
NCT03039192 is a clinical study titled "54135419SUI3001: 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 the 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...
What is the current status of trial NCT03039192?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 226 participants. The study started on 2017-06-09. Estimated completion is 2018-12-18.
What conditions does trial NCT03039192 study?
This clinical trial studies the following conditions: Depressive Disorder, Major.
What interventions are being tested in trial NCT03039192?
The interventions under investigation include: Placebo (OTHER), Standard of Care (OTHER), Esketamine (DRUG).
Who is sponsoring clinical trial NCT03039192?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03039192 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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