CompletedNCT02418585
A Study to Evaluate the Efficacy, Safety, and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression
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?
This study was for people with depression. Listed age limits: 18 years to 64 years. Other eligibility criteria applied.
- Listed locations
- Birmingham and 47 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: August 7, 2015
- Recruitment status
- Completed
- Enrollment listed in the registry
- 236
- Sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Other organization
- Study type
- Drug
- Intervention type
- Medication / drug
- Study phase
- Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
- Locations
- United States, Czechia, Germany, ...
- Age range
- From 18 Years to 64 Years
- Official registry ID
- NCT02418585
- Official title
Show the full official title
A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depression
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Recruitment & locations
CompletedBirmingham, United States · Orange, United States · San Rafael, United States
46 more locations
- Maitland, United States
- Atlanta, United States
- Chicago, United States
- Gaithersburg, United States
- Boston, United States
- Philadelphia, United States
- Dallas, United States
- Klecany, Czechia
- Litoměřice, Czechia
- Pilsen, Czechia
- Prague, Czechia
- Přerov, Czechia
- Berlin, Germany
- Cham, Germany
- Dresden, Germany
- Gelsenkirchen, Germany
- Halle, Germany
- Leipzig, Germany
- Mainz, Germany
- Mannheim, Germany
- Mittweida, Germany
- Pfaffenhofen, Germany
- Prien am Chiemsee, Germany
- Tübingen, Germany
- Bialystok, Poland
- Bydgoszcz, Poland
- Gdansk, Poland
- Krakow, Poland
- Mysłowice, Poland
- Pruszków, Poland
- Torun, Poland
- Tuszyn, Poland
- Warsaw, Poland
- Alcorcón, Spain
- Barcelona, Spain
- Córdoba, Spain
- Málaga, Spain
- Móstoles, Spain
- Murcia, Spain
- Palma, Spain
- Pamplona, Spain
- Sabadell, Spain
- Salamanca, Spain
- Santa Coloma de Gramanet, Spain
- Vitoria-Gasteiz, Spain
- Czechia
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, Placebo, Duloxetine (Oral Antidepressant), Escitalopram (Oral antidepressant), Sertraline (Oral Antidepressant) and Venlafaxine Extended Release (XR) (Oral Antidepressant).
Who was this study for?
This study was for people with depression. Listed age limits: 18 years to 64 years. Other eligibility criteria applied.
