Chronic PainPhase 4PEAKNCT06317636
Propofol-Enhanced Assessment of Ketamine for Chronic Pain and Depression
A Phase 4 study testing Ketamine and Normal saline in people with Chronic Pain and Depression, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Pain, Depression
- What is being tested?
- Ketamine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2025to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years old
- Comfortable speaking and writing in English
- Chronic pain present daily 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Single-center, Noninferiority Trial of Ketamine Given During Sedation to Patients With Chronic Pain and Depression
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:
Read more
- 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
Read the 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 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 and recall 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. A n=6 pilot feasibility phase will precede the fully-powered n=34 randomized controlled trial.
Enrollment for the n=6 pilot phase is complete as of 6/19/2025.
- Conditions
- Chronic Pain, Depression
- Being tested
- Ketamine, Normal saline
- Keywords
- Chronic Pain, Depression, Ketamine, Propofol, Sedation, Psychotropic Drugs, Hypnotics and Sedatives, Dissociative Anesthetics
- Medical subject headings
- Chronic Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar
0.5 mg/kg ketamine infused intravenously over 40 minutes
Normal salineDrug
Also called 0.9% NaCl
0.9% normal saline infused intravenously over 40 minutes
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Active comparator | A one-time intravenous infusion of ketamine (0.5 mg/kg) Receives: Drug: Ketamine |
| Saline | Placebo comparator | A one-time intravenous infusion of normal saline Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity in the 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.
Measured: screening; 1, 7, 14, 21 and 28 days after treatment
Secondary outcomes (1)
Depression Severity and Blinding
The 16-item Quick Inventory of Depressive Symptomatology Self-Report will be used to assess the severity of depressive symptoms. Items are self-rated on a 4-point scale tailored to each depression-related symptom. Higher total scores indicate greater depression symptom severity.
Blinding will be assessed by asking participants to guess which treatment they received and rate their certainty on a simple 0-100 scale.
Measured: screening; day of infusion pre-treatment; 7, 14, 21 and 28 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start28 Jan 2025
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theresa Lii, Stanford University
- Investigators
- Theresa Lii, MD, MS, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317636
- Sponsor's protocol ID
- 73487
- Acronym
- PEAK
- Status last verified
- Sep 2025
- First submitted
- 27 Feb 2024
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data, study outcomes, and data dictionaries
Publications
Lii TR, Sikka P, Deverett B, Altirkawi OK, Heifets BD. Protocol and pilot results for a double-blind randomized placebo-controlled trial of ketamine under propofol sedation for chronic pain and depression. Pain Manag. 2026 Jun;16(6):603-613. doi: 10.1080/17581869.2026.2658080. Epub 2026 Apr 16.
PubMed 41988848
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Single-center, Noninferiority Trial of Ketamine Given During Sedation to Patients With Chronic Pain and Depression
- ClinicalTrials.gov ID
- NCT06317636
- Acronym / sponsor ID
- PEAK / 73487
- Conditions
- Chronic Pain, Depression
- Keywords
- Chronic Pain, Depression, Ketamine, Propofol, Sedation, Psychotropic Drugs, Hypnotics and Sedatives, Dissociative Anesthetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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 and recall 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. A n=6 pilot feasibility phase will precede the fully-powered n=34 randomized controlled trial.
Enrollment for the n=6 pilot phase is complete as of 6/19/2025.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Active comparator | Drug: KetamineA one-time intravenous infusion of ketamine (0.5 mg/kg) |
| Saline | Placebo comparator | Drug: Normal salineA one-time intravenous infusion of normal saline |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 70 years old
- Comfortable speaking and writing in English
- Chronic pain present daily 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineAlso: Ketalar0.5 mg/kg ketamine infused intravenously over 40 minutes | Drug | Ketamine |
| Normal salineAlso: 0.9% NaCl0.9% normal saline infused intravenously over 40 minutes | Drug | Saline |
Primary outcome
Pain intensity in the past 24 hours
Time frame: screening; 1, 7, 14, 21 and 28 days after treatment
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.
1 secondary outcome
Depression Severity and Blinding
Time frame: screening; day of infusion pre-treatment; 7, 14, 21 and 28 days after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Derived from this study: PubMed 41988848Lii TR, Sikka P, Deverett B, Altirkawi OK, Heifets BD. Protocol and pilot results for a double-blind randomized placebo-controlled trial of ketamine under propofol sedation for chronic pain and depression. Pain Manag. 2026 Jun;16(6):603-613. doi: 10.1080/17581869.2026.2658080. Epub 2026 Apr 16.
- Individual participant dataSharing planned: Yes. De-identified participant data, study outcomes, and data dictionaries
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa Lii, MD, MS principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine and Normal saline in people with Chronic Pain and Depression, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity in the past 24 hours (time frame: screening; 1, 7, 14, 21 and 28 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06317636, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.