Randomized, Double-blind, Placebo-controlled, Single-center, Noninferiority Trial of Ketamine Given During Sedation to Patients With Chronic Pain and Depression (PEAK)

NCT06317636 Phase 4 ACTIVE_NOT_RECRUITING

The goal of this clinical trial is to compare ketamine to a placebo when given as a single infusion during IV sedation in adults with chronic pain and depression. We do not know whether ketamine will be more effective than placebo under these circumstances. This study aims to: * Evaluate whether placebo is non-inferior to ketamine in treating chronic pain and depression, when delivered under propofol sedation * Confirm that propofol sedation is a safe way to keep participants blinded to treatment * Assess patients' comfort with the sedation process to improve future studies * Explore whether patient expectations affects their pain and depression Participants will: * Need to qualify for the study based on stringent medical criteria * Undergo sedation with propofol * Randomly receive either a ketamine or a placebo (saline) infusion during sedation * Complete several study assessments over 5-7 weeks

Details

Lead sponsor	Stanford University
Phase	Phase 4
Status	ACTIVE_NOT_RECRUITING
Enrolment	40
Start date	2025-01-28
Completion	2026-12

Conditions

• Chronic Pain
• Depression

Interventions

• Ketamine
• Normal saline

Primary outcomes

• Pain intensity in the past 24 hours — screening; 1, 7, 14, 21 and 28 days after treatment
  A numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain) over the past 24 hours will be used to assess pain intensity.

Countries

United States