Ketamine for Chronic Pain and Depression (PEAK Trial)

Phase 4

Recruiting

Led By Theresa Lii, MD, MS

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 to 70 years old

Chronic pain present for at least 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of opening enrollment to the date of consent from the last participant, assessed up to 60 months

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial aims to see if ketamine is more effective than a placebo in treating chronic pain and depression in adults. Participants will receive either ketamine or a placebo infusion during sedation with propofol

Who is the study for?

This trial is for adults aged 18-70 who have had chronic pain for at least 3 months and are currently experiencing depression. Participants must be able to follow the study's procedures and communicate effectively in English about any adverse events or important clinical information.

What is being tested?

The trial is testing if ketamine is more effective than a placebo (saline) in treating chronic pain and depression when given as a single infusion during sedation with propofol. The study also evaluates patient comfort with sedation and how expectations might influence outcomes.

What are the potential side effects?

Possible side effects include those related to ketamine, such as changes in blood pressure, nausea, dizziness, disorientation, or mood swings. Propofol may cause reactions like pain at the injection site, low blood pressure, or temporary breathing issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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I have been experiencing chronic pain for at least 3 months.

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I am currently experiencing depression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of opening enrollment to the date of consent from the last participant, assessed up to 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of opening enrollment to the date of consent from the last participant, assessed up to 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of opening enrollment to the date of consent from the last participant, assessed up to 60 months for reporting.