Esketamine and Perioperative Depressive Symptoms

Depressive Symptoms Clinical Trial

Official title:

Effect of Esketamine on Perioperative Depressive Symptoms in Patients Undergoing Major Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04425473
• Other study ID #: Z191100006619067
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: February 19, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Beijing Tiantan Hospital
• Contact: Ruquan Han, M.D., Ph D.
• Phone: 8610-59976660
• Email: ruquan.han[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Perioperative depressive symptoms (PDS) are common in population undergoing surgery, and this would be sharpened especially for complicated, high-risk major surgery. However, None of treatments could resolve this clinical problem during limited perioperative period. The remarkable effects of ketamine on treatment resistant depression have been verified by several clinical trials and the enantiomer S-ketamine (esketamine) showed similar antidepressant efficacy with better safety in recent studies. The efficacy and safety of esketamine administrated intra-operatively for PDS will be verified in this study. Other secondary outcomes such as anxiety, postoperative pain and psychiatric symptoms will also be investigated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 564
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patient undergoing elective major surgery
• Ages between 18 and 65 years old
• Moderate to severe depressive symptoms ( the Patient Health Questionnaire-9 scores equal to or more than 10 and Montgomery-Åsberg Depression Rating Scale scores equal to or more than 22 )
• Signed informed consent

Exclusion Criteria:

• Patients combined with aphasia or other conditions leads that patients inability to cooperate with the metal assessments;
• Tumor related injury of the 9th, 10th, 11th, 12th cranial nerve or patients need keeping intubation after surgery;
• Medical history of psychotic or bipolar disorder;
• Laboratory evidence of hormone levels disorder due to primary diseases;
• Body Mass Index more than 30 kg/?;
• Child-Pugh grade B or C;
• Major depressive disorder with antidepressant therapy in the past 2 weeks before screening;
• History of adverse events to ketamine or esketamine;
• Patients with repeated suicide attempts (QIDS-SR 12-item more than or equal to 3);
• History of drug abused;
• Pregnant or breastfeeding woman.

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Esketamine
• Major Surgery
• Perioperative Complication

Intervention

Drug:
• Esketamine
Esketamine will be administrated intravenously when suturing incision, with total dose of 0.2mg/kg and continuous infusion for 40 minutes.
• Normal saline
Equivalent amount of normal saline will be administrated intravenously suturing incision.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive symptoms remission	Remission is defined as MADRS total score no more than 10	Postoperative 3-day
Secondary	MADRS scores	The differences in MADRS scores	Postoperative 3-day
Secondary	Depressive symptoms response	The rates of patients achieving a response	Postoperative 3-day
Secondary	Severe pain	The rate of severe pain after surgery	postoperative 3-day
Secondary	Side-effects and Adverse events	All drug-related adverse events during surgery or before discharge	During surgery or up to 7 days after surgery