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Propofol-Enhanced Assessment of Ketamine for Chronic Pain and Depression

Study acronym: PEAK
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Secondary endpoint revisedv10
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study description expanded, about 11 words
    • Site details revised
    v9
  3. Re-verified, no change to tracked fieldsv8
  4. Start date: Nov 18, 2024 to Jan 28, 2025v7
  5. Trial status: Not Yet Recruiting to Recruitingv6 Show 4 more changesShow less
    • Enrollment target: 38 to 40
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 2024 to Nov 18, 2024
    • Study description expanded, about 1 word
Show 4 earlier versionsHide 4 earlier versions
  1. Primary endpoint revised
    • Secondary endpoints: 2 to 1
    • Eligibility criteria expanded, about 1 word
    • Study description shortened, about 1 word
    v5
  2. Phase: Phase 2 to Phase 4v4 Show 5 more changesShow less
    • Primary completion date: Jan 2025 to Nov 2026
    • Start date: May 2024 to Oct 2024
    • Enrollment target: 32 to 38
    • Study completion date: May 2025 to Dec 2026
    • Study description expanded, about 14 words
  3. Primary endpoint revised
    • Secondary endpoints: 1 to 2
    v3
  4. Study description expanded, about 1 wordv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Stanford University
634 trials monitored
See 47 trials at risk
Depression
3,055 trials monitored
See 173 trials at risk
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
Trial Details
NCT Number NCT06317636
Lead Sponsor Stanford University
Conditions
(from sponsor)		 Chronic Pain, Depression
Related terms Chronic Pain, Depression
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov