CompletedNCT03039192
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 Suicide prevention, in Adult Participants Assessed to be at Imminent Risk for Suicide
This study evaluated the safety and effectiveness of Esketamine for people with depression.
Medication studyAges 18–64Multiple countries
Understand this study
What did researchers investigate?
This study evaluated the safety and effectiveness of Esketamine for people with depression.
Who was this study for?
Listed age limits: 18 years to 64 years.
- Listed locations
- Birmingham and 55 more locationsSee all locations and recruitment
- Study phase
- Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Study information
Study start dateStarted: June 9, 2017
- Recruitment status
- Completed
- Enrollment listed in the registry
- 226
- Sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Other organization
- Study type
- Drug
- Intervention type
- Medication / drug, OTHER
- Study phase
- Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
- Locations
- United States, Bulgaria, Estonia, ...
- Age range
- From 18 Years to 64 Years
- Official registry ID
- NCT03039192
- Official title
Show the full official title
A Double-blind, Randomized, Placebo-controlled 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 Subjects Assessed to be at Imminent Risk for Suicide
Recruitment & locations
CompletedBirmingham, United States · Chandler, United States · Garden Grove, United States
46 more locations
- New Haven, United States
- Chicago, United States
- Hoffman Estates, United States
- Louisville, United States
- New Orleans, United States
- Shreveport, United States
- Baltimore, United States
- Gaithersburg, United States
- Buffalo, United States
- New York, United States
- Hickory, United States
- Columbus, United States
- Charleston, United States
- Dallas, United States
- Bulgaria, Bulgaria
- Burgas, Bulgaria
- Lovech, Bulgaria
- Plovdiv, Bulgaria
- Sofia, Bulgaria
- Tallinn, Estonia
- Tartu, Estonia
- Berlin, Germany
- Frankfurt am Main, Germany
- Freiburg im Breisgau, Germany
- Budapest, Hungary
- Győr, Hungary
- Pécs, Hungary
- Cheras, Malaysia
- Kuala Lumpur, Malaysia
- Seremban, Malaysia
- Žilina, Slovakia
- Cape Town, South Africa
- Welgemoed, South Africa
- Gwangju, South Korea
- Gyeonggi-do, South Korea
- Seoul, South Korea
- Alcorcón, Spain
- Barcelona, Spain
- Bilbao, Spain
- Madrid, Spain
- Pamplona, Spain
- Sant Boi de Llobregat, Spain
- Neihu District, Taiwan
- New Taipei City, Taiwan
- Taichung, Taiwan
- Taipei, Taiwan
Questions about this study
What did researchers investigate?
This study evaluated the safety and effectiveness of Esketamine for people with depression.
Who is behind this study?
The study sponsor is Janssen Research & Development, LLC.
Did this study involve medication?
Yes. The study involved medication, including Esketamine.
Who was this study for?
Listed age limits: 18 years to 64 years.
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A Double-blind Study to Assess the Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicide prevention, in Participants Who Are Assessed to be at Imminent Risk for Suicide