Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06317636
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-02-27
Brief Title:
Propofol-Enhanced Assessment of Ketamine for Chronic Pain and Depression
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Randomized Double-blind Placebo-controlled Trial of Ketamine Given During Propofol Sedation in Patients with Chronic Pain and Depression
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEAK
Brief 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 ketamine is more effective than a placebo in treating chronic pain and depression
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
This study aims to
Evaluate whether ketamine is more effective than a placebo in treating chronic pain and depression
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
Detailed Description:
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 ketamines ability to treat chronic pain and depression are poorly understood A most basic question regarding ketamines therapeutic mechanism is still unresolved do patients need to consciously experience and recall ketamines 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 n6 pilotfeasibility phase will precede the fully-powered n32 randomized controlled trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None