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
Ketamine is a dissociative anesthetic that has been in clinical use for more than 50 years. In addition to its well-known anesthetic and pain-relieving properties, ketamine has been found to have fast-acting antidepressant effects in patients with depression. However, the mechanisms underlying ketamine's ability to treat chronic pain and depression are poorly understood. A most basic question regarding ketamine's therapeutic mechanism is still unresolved: do patients need to consciously experience and recall ketamine's acute dissociative effects to receive lasting analgesic and antidepressant benefits? In this clinical trial, participants will receive either ketamine or a placebo when they are under sedation with propofol. A n=6 pilot feasibility phase will precede the fully-powered n=34 randomized controlled trial. Enrollment for the n=6 pilot phase is complete as of 6/19/2025.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
0.5 mg/kg ketamine infused intravenously over 40 minutes
0.9% normal saline infused intravenously over 40 minutes
Stanford University
Stanford, California, United States
Pain intensity in the past 24 hours
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.
Time frame: screening; 1, 7, 14, 21 and 28 days after treatment
Depression Severity and Blinding
The 16-item Quick Inventory of Depressive Symptomatology Self-Report will be used to assess the severity of depressive symptoms. Items are self-rated on a 4-point scale tailored to each depression-related symptom. Higher total scores indicate greater depression symptom severity. Blinding will be assessed by asking participants to guess which treatment they received and rate their certainty on a simple 0-100 scale.
Time frame: screening; day of infusion pre-treatment; 7, 14, 21 and 28 days after treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.