Comparing ketamine and placebo for chronic pain and depression under sedation
Randomized, Double-blind, Placebo-controlled, Single-center, Noninferiority Trial of Ketamine Given During Sedation to Patients With Chronic Pain and Depression
This study is testing if ketamine can help people with chronic pain and depression feel better while they are sedated, compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT06317636 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of ketamine compared to a placebo in treating chronic pain and depression during intravenous sedation with propofol. Participants will be randomly assigned to receive either ketamine or saline while under sedation, allowing for a blinded assessment of treatment effects. The study will also assess the safety of propofol sedation and explore how patient expectations may influence outcomes. A pilot phase will precede a larger randomized controlled trial to ensure feasibility and refine methodologies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with chronic pain lasting at least three months and currently experiencing depression.
Not a fit: Patients who are pregnant, breastfeeding, or have health conditions that make participation unsafe will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective treatments for patients suffering from chronic pain and depression.
How similar studies have performed: While ketamine has shown promise in treating depression and pain, this specific approach under propofol sedation is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 to 70 years old * Comfortable speaking and writing in English * Chronic pain present daily for at least 3 months * Currently experiencing depression * Able to comply with the study protocol and communicate with study personnel about adverse events and other clinically important information Exclusion Criteria: * Pregnant or breastfeeding * One or more health conditions that makes study unsafe or unfeasible, determined by study physicians * Regular use of medications that may have problematic interactions with the study drugs * Participating in another clinical trial which may conflict with this one
Where this trial is running
Stanford, California
- Stanford University — Stanford, California, United States (Recruiting)
Study contacts
- Principal investigator: Theresa Lii, MD, MS — Stanford University
- Study coordinator: Theresa Lii, MD, MS
- Email: tlii@stanford.edu
- Phone: 650-264-9442
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.