Propofol-Enhanced Assessment of Ketamine for Chronic Pain and Depression

Depression Clinical Trial

— PEAK  

Official title:

Randomized Double-blind Placebo-controlled Trial of Ketamine Given During Propofol Sedation in Patients With Chronic Pain and Depression

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06317636
• Other study ID #: 73487
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 2024
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: Theresa Lii, MD, MS
• Phone: 650-264-9442
• Email: tlii[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare ketamine to a placebo when given as a single infusion during sedation in adults with chronic pain and depression. 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

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 repeatedly been found to have fast-acting antidepressant effects in patients with depression. However, the mechanisms underlying ketamine's ability to treat chronic pain and depression are poorly understood. A most basic question regarding ketamine's therapeutic mechanism is still unresolved: do patients need to consciously experience ketamine's 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: May 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 18 to 70 years old
• Comfortable speaking and writing in English
• Chronic pain present 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

Related Conditions & MeSH terms

• Chronic Pain
• Depression
• Depressive Disorder

Intervention

Drug:
• Ketamine
0.5 mg/kg ketamine infused intravenously over 40 minutes
• Normal saline
0.9% normal saline infused intravenously over 40 minutes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number and severity of adverse events related to sedation	Adverse events (AEs) will be assessed through a combination of patient self-report, interviews by study staff, and surveillance of medical records by the research team. AEs will be graded by severity (1=mild, 2=moderate, 3=severe, 4=life threatening, and 5=death) and relatedness to the intervention (0=definitely unrelated, 1=unlikely, 2=possibly related, 3=probably related, 4 definitely related).	during the intervention; immediately after the intervention; 7, 14, 21 and 28 days after treatment
Other	Proportion of participants who accurately recall intra-sedation events	Participants will be interviewed by study staff using the modified Brice Questionnaire, a set of questions asked in sequence to determine if the participant remembers anything between the time of induction and their awakening.	immediately after the intervention
Other	Treatment guess	Participants will be asked to guess their assigned treatment in a forced binary choice and to rate their level of confidence on a scale from 0 to 100%. They will also be asked to provide reasons for their guess.	immediately after the intervention; 28 days after treatment
Other	Treatment expectancies	The Stanford Expectations of Treatment Scale (SETS) measures the extent of positive and negative treatment expectancies. Participants are asked to rate their agreement with 6 brief statements on a 7-point scale ranging from 1 ("Strongly Disagree") to 7 ("Strongly Agree"). Higher scores correspond to stronger expectancies.	screening; immediately after the intervention
Other	Pain interference	The 6-item PROMIS Pain Interference Short Form assesses the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Items are self-rated on a 5-point scale ranging from 1 ("Not at all") to 5 ("Very Much"). Raw score totals are converted to standardized T-scores, with a higher T-score representing greater pain interference.	screening; immediately before the intervention; 7, 14, 21 and 28 days after treatment
Other	Physical function	The 6-item PROMIS Physical Function Short Form assesses the ability to carry out physical tasks and activities in one's daily life. Items are self-rated on a 5-point scale ranging from 1 ("Unable to do") to 5 ("Without any difficulty"). Raw score totals are converted to standardized T-scores, with a higher T-score representing better physical function.	screening; immediately before the intervention; 7, 14, 21 and 28 days after treatment
Other	Number of painful body regions	The CHOIR Body Map is a visual tool that allows individuals to indicate the location(s) of their pain on a human body outline.	screening; immediately before the intervention; immediately after the intervention; 7, 14, 21 and 28 days after treatment
Other	Change in pain medication utilization	Participants are asked to rate how their pain medication usage has changed compared to before treatment	7, 14, 21 and 28 days after treatment
Other	Pressure pain threshold	A pressure algometer device applied to the upper trapezius muscle will measure the pressure pain threshold by applying a controlled, gradually increasing force until the participant reports pain.	screening; immediately after the intervention
Other	Enrollment rate	The total number of consented, eligible participants enrolled by the end of the study divided by the amount of time between date of opening enrollment and the date of consent from the last participant.	from date of opening enrollment to the date of consent from the last participant, assessed up to 60 months
Other	Consent fraction	The proportion of patients who are contacted by study staff for recruitment who provide written informed consent to study procedures.	from date of opening enrollment to the date of consent from the last participant, assessed up to 60 months
Other	Participant Experience Survey	Participants are asked at the end of the study to rate their experience with study procedures and to provide feedback for improvement.	through study completion, an average of 4 weeks
Primary	Pain Intensity (past 24 hours)	A numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain) over the past 24 hours will be used to assess pain intensity.	screening; 7, 14, 21 and 28 days after treatment
Secondary	Depression severity	The 21-item Beck Depression Inventory-II (BDI-II) assesses the severity of depressive symptoms experienced over the past 1 week. Items are self-rated on a 4-point scale. Higher total scores indicate greater depression symptom severity.	screening; immediately before the intervention; 7, 14, 21 and 28 days after treatment
Secondary	Pain Intensity (current)	A numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain) assessing current pain	immediately before the intervention; immediately after the intervention