252
Participants
Start Date
May 25, 2018
Primary Completion Date
April 13, 2021
Study Completion Date
April 13, 2021
Esketamine 56 mg
Participants will self-administer 56 mg of esketamine as intranasal spray.
Esketamine 84 mg
Participants will self-administer 84 mg of esketamine as intranasal spray.
Placebo
Participants will self-administer matching placebo as intranasal spray.
Duloxetine (Oral Antidepressant)
Duloxetine can be selected as the oral antidepressant medication based on investigator's discretion. The minimum therapeutic dose is 60 milligram per day (mg/day).
Escitalopram (Oral Antidepressant)
Escitalopram can be selected as the oral antidepressant medication based on investigator's discretion. Escitalopram will be started at a dose of 10 mg/day and up-titrated to a maximum dose of 20 mg/day.
Sertraline (Oral Antidepressant)
Sertraline can be selected as the oral antidepressant medication based on investigator's discretion. Sertraline will be started at a dose of 50 mg/day and up-titrated to a maximum dose of 200 mg/day.
Venlafaxine Extended Release (XR) (Oral Antidepressant)
Venlafaxine XR can be selected as the oral antidepressant medication based on investigator's discretion. Venlafaxine XR will be started at a dose of 75 mg/day and up-titrated to a maximum dose of 225 mg/day.
The Medical Research Network, LLC, New York
CBH Health, Gaithersburg
Atlanta Center for Medical Research, Atlanta
IPS Research Company, Oklahoma City
Beijing Anding Hospital of Capital Medical University, Beijing
Beijing HuiLong Guan Hospital, Beijing
Peking University Sixth Hospital, Beijing
Nanjing Brain Hospital Affilicated to Nanjing Medical University, Nanjing
Tianjin Anding Hospital, Tianjin
Hangzhou Seventh People's Hospital, Hangzhou
First Hospital, Zhejiang University Medical College, Hangzhou
The Second Affiliated Hospital of Zhejiang University, Hangzhou
Huzhou third people's Hospital, Huzhou
Xiamen Xianyue Hospital, Xiamen
Chongqing Mental Health Center, Chongqing
The Second People's Hospital of Hunan Province / Brian Hospital of Hunan Province, Changsha
The second Xiangya Hospital of Central South University, Changsha
Renmin Hospital of Wuhan University, Wuhan
The First Affiliated Hospital of Zhengzhou University, Zhengzhou
the 3rd Affiliated Hospital,Sun Yansen University, Guangzhou
Guangdong Provincial People's Hospital, Guangzhou
West China Hospital Sichuan University, Chengdu
First Affiliated Hospital of Kunming Medical Unversity, Kunming
The First Affiliated Hospital of Xian Jiaotong University, Xi'an
Xi'an Mental Health Center, Xi'an
Urumqi fourth Hospital, Ürümqi
The first affiliated hospital of Xinjiang medical university, Ürümqi
Biomedical Research Foundation of Northwest Louisiana, Shreveport
Adams Clinical, Watertown
The First Hospital of Hebei Medical University, Shijiazhuang
Janssen Research & Development, LLC
INDUSTRY