Esketamine and Perioperative Depressive Symptoms

Phase 2

Recruiting

• Conditions: Major Surgery; Perioperative Complication; Depressive Symptoms; Esketamine
• Interventions: Drug: Normal saline; Drug: Esketamine

• Registration Number: NCT04425473
• Lead Sponsor: Beijing Tiantan Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-08
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Study Start: 2021-02-19
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-22
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 564

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Normal saline	-
Esketamine	Esketamine	-

Primary Outcome Measures

Name	Time	Method
Depressive symptoms remission	Postoperative 3-day	Remission is defined as MADRS total score no more than 10

Secondary Outcome Measures

Name	Time	Method
MADRS scores	Postoperative 3-day	The differences in MADRS scores
Severe pain	postoperative 3-day	The rate of severe pain after surgery
Side-effects and Adverse events	During surgery or up to 7 days after surgery	All drug-related adverse events during surgery or before discharge
Depressive symptoms response	Postoperative 3-day	The rates of patients achieving a response

Trial Locations

Locations (1)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, China