Clinical TrialDepressive DisordersKetaminePlaceboActive not recruiting

Propofol-Enhanced Assessment of Ketamine for Chronic Pain and Depression (PEAK)

This Phase IV trial (n=40) investigates if a placebo is non-inferior to ketamine in treating chronic pain and depression when delivered under sedation (with propofol).

Target Enrollment
40 participants
Study Type
Phase IV interventional
Design
Randomized, quadruple Blind

Detailed Description

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

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Ketamine 0.5 mg/kg (under propofol sedation)

experimental

Single IV infusion of ketamine 0.5 mg/kg over 40 minutes, administered while the participant is under propofol sedation to preserve blinding.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose over 40 minutes• 1 doses total

Normal saline placebo (under propofol sedation)

inactive

Single IV infusion of 0.9% normal saline over 40 minutes, administered while the participant is under propofol sedation — propofol is given to both arms to keep participants blinded to treatment.

Interventions

  • Placebo other
    via IV• single infusion over 40 minutes• 1 doses total

    0.9% NaCl saline, volume-matched to ketamine arm.

Participants

Ages
18 – 70
Sexes
Male & Female

Inclusion Criteria

  • Adults aged 18–70
  • Daily chronic pain for ≥3 months
  • Currently experiencing depression
  • Fluent in English and able to comply with study procedures

Exclusion Criteria

  • Pregnancy or breastfeeding
  • Medical contraindications to ketamine or propofol (per study physicians)
  • Concomitant medications with problematic interactions with study drugs
  • Concurrent participation in another conflicting clinical trial

Study Details

  • Status
    Active not recruiting
  • Phase
    Phase IV
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment40 participants
  • Timeline
    Start: 2025-01-28
    End: 2026-12-01
  • Compounds
    KetaminePlacebo
  • Topic
    Depressive Disorders

Study Team

Sponsors & Collaborators

Locations

Stanford University — Stanford, California, United States

Related Publications

Protocol and pilot results for a double-blind randomized placebo-controlled trial of ketamine under propofol sedation for chronic pain and depression

Published
Authors
Lii, T. R., Sikka, P., Deverett, B., Altirkawi, O. K., Heifets, B. D.