Esketamine and Perioperative Depressive Symptoms

Capital Medical University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Perioperative Complication; Depressive Symptoms; Esketamine; Major Surgery

Treatments: Drug: Esketamine; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04425473

Z191100006619067

Details and patient eligibility

About

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.

Enrollment: 435 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

• had aphasia or any conditions that prevented mental health assessments,
• had a history of psychotic or bipolar disorder,
• had a comorbidity that affected hormone levels,
• required prolonged postoperative mechanical ventilation,
• had received treatment with antidepressants within 2 weeks prior to the screening,
• had a body mass index greater than 30 kg/m2 and a Child-Pugh score greater than 6 points.
• had made repeated suicide attempts (as assessed by the 12-item Quick Inventory of Depressive Symptomatology scores less than 3),
• had experienced adverse reactions to ketamine or esketamine,
• had known drug use disorders,
• pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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435 participants in 2 patient groups, including a placebo group

Esketamine

Experimental group

Treatment:

Drug: Esketamine

Placebo

Placebo Comparator group

Treatment:

Drug: Normal saline