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Propofol-Enhanced Assessment of Ketamine for Chronic Pain and Depression

NCT06317636 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-10-02

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Ketamine

0.5 mg/kg ketamine infused intravenously over 40 minutes

DRUG

Normal saline

0.9% normal saline infused intravenously over 40 minutes

Sponsors & Collaborators

Principal Investigators

  • Theresa Lii, MD, MS · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-28
Primary Completion
2026-11-30
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06317636 on ClinicalTrials.gov