Esketamine and Perioperative Depressive Symptoms

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tiantan Hospital
• Treatments: Esketamine

Criteria

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.