NCT05233566

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Postoperative Depression

Interventions

Type	Name	Description
DRUG	Ketamine	NMDA antagonist
DRUG	Normal saline	IV fluid acting as a placebo

Timeline

• Start date: 2022-04-25
• Primary completion: 2023-03-08
• Completion: 2023-03-08
• First posted: 2022-02-10
• Last updated: 2026-02-12
• Results posted: 2024-04-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study