CompletedNCT03434041
A Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression
Medication studyAges 18–64China + United States
Understand this study
Who was this study for?
Listed age limits: 18 years to 64 years.
- Listed locations
- Atlanta and 29 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: May 25, 2018
- Recruitment status
- Completed
- Enrollment listed in the registry
- 252
- 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, China
- Age range
- From 18 Years to 64 Years
- Official registry ID
- NCT03434041
- Official title
Show the full official title
A Randomized, Double-blind, Multicenter Active-controlled Study to Evaluate the Efficacy, Pharmacokinetics, 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
CompletedAtlanta, United States · Shreveport, United States · Gaithersburg, United States
19 more locations
- Watertown, United States
- New York, United States
- Oklahoma City, United States
- Beijing, China
- Changsha, China
- Chengdu, China
- Chongqing, China
- Guangzhou, China
- Hangzhou, China
- Huzhou, China
- Kunming, China
- Nanjing, China
- Shijiazhuang, China
- Tianjin, China
- Ürümqi, China
- Wuhan, China
- Xi'an, China
- Xiamen, China
- Zhengzhou, China
Questions about this study
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 56 mg, Esketamine 84 mg, Placebo, Duloxetine (Oral Antidepressant), Escitalopram (Oral Antidepressant), Sertraline (Oral Antidepressant) and Venlafaxine Extended Release (XR) (Oral Antidepressant).
Who was this study for?
Listed age limits: 18 years to 64 years.
