Ketamine for Postoperative Avoidance of Depressive Symptoms: The K-PASS Feasibility Trial — K-PASS  

Postoperative Depression Clinical Trial

Official title: Ketamine for Postoperative Avoidance of Depressive Symptoms: The K-PASS Feasibility Trial

Status Completed

Clinical Trial Summary

This protocol describes a feasibility trial that will evaluate the feasibility of conducting a full-scale phase 3 trial testing the hypothesis that a postoperative sustained, low-dose ketamine infusion can prevent postoperative depressive symptoms when administered to a targeted population of neurosurgical patients with a history of depression.

Clinical Trial Description

This protocol describes a feasibility trial that will evaluate the feasibility of conducting a full-scale phase 3 trial. Both the feasibility trial and the full-scale trial will follow a randomized, placebo-controlled, double-blinded, parallel design. The trial will follow a superiority design. This trial will take place at a single site (Washington University in St. Louis School of Medicine/Barnes-Jewish Hospital).

Following extubation, patients will be randomized to the intervention (ketamine group) or to control (control group). Patients in the ketamine group will receive a bolus of ketamine 0.5 mg/kg intravenously over 10 minutes, followed by an infusion at 0.3 mg/kg/h for an additional 2 hours 50 minutes. Patients in the control group will receive an equal volume of normal saline. Patients, research staff performing assessments, and research staff performing data analysis will be blinded to treatment allocation. ;

Related Conditions & MeSH terms

• Depression
• Postoperative Depression

• NCT number: NCT05233566
• Study type: Interventional
• Source: Washington University School of Medicine
• Status: Completed
• Phase: Phase 3
• Start date: April 25, 2022
• Completion date: March 8, 2023