CompletedNCT04338321
A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder
Medication studyAges 18–74Multiple countriesDepression
Understand this study
Who was this study for?
Listed age limits: 18 years to 74 years.
- Listed locations
- Buenos Aires and 170 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 21, 2020
- Recruitment status
- Completed
- Enrollment listed in the registry
- 676
- Sponsor
- Janssen-Cilag International NV
- Sponsor type
- Unknown or unclear
- 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
- Belgium, Argentina, Austria, ...
- Age range
- From 18 Years to 74 Years
- Official registry ID
- NCT04338321
- Official title
Show the full official title
A Randomized, Open-label, Rater-Blinded, Active-Controlled, International, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Flexibly Dosed Esketamine Nasal Spray Compared With Quetiapine Extended-Release in Adult and Elderly Participants With Treatment-Resistant Major Depressive Disorder Who Are Continuing a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor
Recruitment & locations
CompletedBuenos Aires, Argentina · Córdoba, Argentina · La Plata, Argentina
126 more locations
- Rosario, Argentina
- Graz, Austria
- Vienna, Austria
- Alken, Belgium
- Duffel, Belgium
- Henri-Chapelle, Belgium
- Heusden-Zolder, Belgium
- Lede, Belgium
- Liège, Belgium
- Belo Horizonte, Brazil
- Curitiba, Brazil
- Rio de Janeiro, Brazil
- São Paulo, Brazil
- Kardzhali, Bulgaria
- Pleven, Bulgaria
- Plovdiv, Bulgaria
- Rousse, Bulgaria
- Sofia, Bulgaria
- Brno, Czechia
- Hradec Kralove-Vekose, Czechia
- Pilsen, Czechia
- Prague, Czechia
- Aalborg, Denmark
- Esbjerg N, Denmark
- Helsinki, Finland
- Kuopio, Finland
- Aachen, Germany
- Alzey, Germany
- Berlin, Germany
- Bonn, Germany
- Chemnitz, Germany
- Cottbus, Germany
- Dortmund, Germany
- Dresden, Germany
- Frankfurt am Main, Germany
- Freiburg im Breisgau, Germany
- Gera, Germany
- Göttingen, Germany
- Greifswald, Germany
- Hamburg, Germany
- Hanover, Germany
- Heidelberg, Germany
- Hennigsdorf, Germany
- Homburg, Germany
- Jena, Germany
- Leipzig, Germany
- Magdeburg, Germany
- Mainz, Germany
- Mittweida, Germany
- Münster, Germany
- Neuruppin, Germany
- Nuremberg, Germany
- Oberhausen, Germany
- Pfaffenhofen, Germany
- Schwerin, Germany
- Stralsund, Germany
- Athens, Greece
- Crete, Greece
- Heraklion, Greece
- Ioannina, Greece
- Pátrai, Greece
- Thessaloniki, Greece
- Budapest, Hungary
- Debrecen, Hungary
- Gyöngyös, Hungary
- Győr, Hungary
- Kalocsa, Hungary
- Nyíregyháza, Hungary
- Pécs, Hungary
- Haifa, Israel
- Hod HaSharon, Israel
- Lod, Israel
- Petah Tikva, Israel
- Ramat Gan, Israel
- Telaviv, Israel
- Almaty, Kazakhstan
- Nur-Sultan, Kazakhstan
- Ust-Kamenogorsk, Kazakhstan
- Ipoh, Malaysia
- Kuala Lumpur, Malaysia
- Serdang, Malaysia
- Seremban, Malaysia
- Amsterdam, Netherlands
- Leiden, Netherlands
- Hordaland, Norway
- Moss, Norway
- Trondheim, Norway
- Bialystok, Poland
- Bydgoszcz, Poland
- Gdansk, Poland
- Katowice, Poland
- Leszno, Poland
- Lodz, Poland
- Lublin, Poland
- Torun, Poland
- Braga, Portugal
- Guilhufe - Penafiel, Portugal
- Lisbon, Portugal
- Loures, Portugal
- Cape Town, South Africa
- Garsfontein, South Africa
- Gwangju, South Korea
- Iksan, South Korea
- Seoul, South Korea
- Gothenburg, Sweden
- Halmstad, Sweden
- Luleå, Sweden
- Lund, Sweden
- Skövde, Sweden
- Stockholm, Sweden
- Changhua, Taiwan
- Hualien City, Taiwan
- Kaohsiung City, Taiwan
- Tainan, Taiwan
- Taipei, Taiwan
- Taoyuan, Taiwan
- Ankara, Türkiye
- Bursa, Türkiye
- Istanbul, Türkiye
- Izmir, Türkiye
- Konya, Türkiye
- Samsun, Türkiye
- Tekirdağ, Türkiye
- Abu Dhabi, United Arab Emirates
- Czechia
- Türkiye
Questions about this study
Who is behind this study?
The study sponsor is Janssen-Cilag International NV.
Did this study involve medication?
Yes. The study involved medication, including Esketamine 28 mg, Esketamine 56 mg, Esketamine 84 mg, Quetiapine XR 50 mg, Quetiapine XR 100 mg, Quetiapine XR 150 mg and SSRI/SNRI.
Who was this study for?
Listed age limits: 18 years to 74 years.
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