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
研究单位：[1]Janssen Research & Development, LLC[2]Atlanta Center for Medical Research,Atlanta,Georgia,United States,30331[3]Biomedical Research Foundation of Northwest Louisiana,Shreveport,Louisiana,United States,71104-2136[4]CBH Health,Gaithersburg,Maryland,United States,20877[5]Adams Clinical,Watertown,Massachusetts,United States,02472[6]The Medical Research Network, LLC,New York,New York,United States,10128[7]IPS Research Company,Oklahoma City,Oklahoma,United States,73106[8]Beijing Anding Hospital of Capital Medical University,Beijing,China,100088Chile[9]Beijing HuiLong Guan Hospital,Beijing,China,100096[10]Peking University Sixth Hospital,Beijing,China,100191[11]The Second People''s Hospital of Hunan Province / Brian Hospital of Hunan Province,Changsha,China,410007[12]The second Xiangya Hospital of Central South University,Changsha,China,410011[13]West China Hospital, Sichuan University,Chengdu,China,610041[14]Chongqing Mental Health Center,Chongqing,China,401147[15]the 3rd Affiliated Hospital,Sun Yansen University,Guangzhou,China,510000[16]Guangdong Provincial People''s Hospital,Guangzhou,China,510100[17]Hangzhou Seventh People''s Hospital,Hangzhou,China,310000[18]First Hospital, Zhejiang University Medical College,Hangzhou,China,310003[19]The Second Affiliated Hospital of Zhejiang University,Hangzhou,China,310009[20]Huzhou third people''s Hospital,Hu Zhou,China,313000[21]First Affiliated Hospital of Kunming Medical Unversity,Kunming City,China,650032[22]Nanjing Brain Hospital Affilicated to Nanjing Medical University,Nanjing,China,210000[23]The First Hospital of Hebei Medical University,Shijiazhuang,China,050031[24]Tianjin Anding Hospital,Tianjin,China,300222[25]Urumqi fourth Hospital,Urumqi,China,830000[26]The first affiliated hospital of Xinjiang medical university,Urumqi,China,830054[27]Renmin Hospital of Wuhan Universtiy / Hubei General Hospital,Wuhan,China,430060[28]The First Affiliated Hospital of Xi''an Jiaotong University,Xi''an,China,710061[29]Xi''an Mental Health Center,Xi''an,China,710061[30]Xiamen Xianyue Hospital,Xia Men,China,361012[31]The First Affiliated Hospital of Zhengzhou University,Zheng Zhou,China,450052
研究目的：
The purpose of this study is to evaluate the efficacy of switching adult participants with treatment-resistant depression (TRD) from a prior antidepressant treatment (to which they have not responded) to flexibly dosed intranasal esketamine (56 milligram [mg] or 84 mg) plus a newly initiated oral antidepressant compared with switching to a newly initiated oral antidepressant (active comparator) plus intranasal placebo, in improving depressive symptoms. Efficacy will be assessed by the change from baseline in the Montgomery Asberg Depression Rating Scale (MADRS) total score from Day 1 (before randomization) to the end of the 4-week double-blind treatment phase.
