A Phase 4 interventional study of Esketamine and Saline Solution in Depression, sponsored by China Medical University, China. Recruiting at 1 site in China. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-22.
Sponsored by China Medical University, China · Phase 4, Interventional, and Treatment
This study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All depression patients undergoing breast cancer operation will be randomized 1:1 to the treatment intervention with general anesthesia as an adjunct to esketamine or saline. The objective of the trial is to evaluate the postoperative depression、gut microbiota、bispectral index data of patients undergoing breast cancer operation with esketamine or saline.
For female patients, breast cancer patients have a high risk of developing depression, and approximately 20%-45% of breast cancer patients suffer from postoperative depression. Esketamine is an anesthetic in analgesia, and has presently become more and more popular for treating anti-depression, particularly for resistant depression.
This study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All depression patients undergoing breast cancer operation will be randomized 1:1 to the treatment intervention with general anesthesia as an adjunct to esketamine or saline. The objective of the trial is to evaluate the postoperative depression、gut microbiota、bispectral index data of patients undergoing breast cancer operation with esketamine or saline
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 72 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →China Medical University, China is the lead sponsor of 93 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to saline.
Drug: Saline Solution
All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to esketamine.
Drug: Esketamine
All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to esketamine 0.2mg/kg.
All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to saline.
Montgomery-asberg Depression Rating Scale score
Changes of Montgomery-asberg Depression Rating Scale score
Time frame: from baseline to postoperative 24 hours
Bispectral index
Changes of bispectral index data
Time frame: from 8pm to 6am on the first postoperative night
Gut microbiota
changs of gut microbiota
Time frame: from baseline to postoperative 72 hours
Plan to share: No
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China Medical University, China