drugset / Trial / NCT04425473

Esketamine and Perioperative Depressive Symptoms

NCT04425473 ↗

Phase 2/3 Completed 435 enrolled Beijing Tiantan Hospital
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2021-02-19
Primary completion
2024-06-23
Completion
2024-11-27

Outcome

Met primary endpoint

paper The remission rate was greater in the esketamine group than in the placebo group at 3 days post-surgery PMID 42119799 ↗

paper 28.3% vs. 11.3%; OR 3.12 [95% CI, 1.79-5.55]; P < 0.001 PMID 42119799 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Esketamine Other / unclassified 0.2 mg/kg Intravenous

Indications