AnxietyEarly Phase 1NCT05086250
Feasibility Study of Oral Ketamine Versus Placebo for the Treatment of Anxiety in Patients With Pancreatic Cancer
A Early Phase 1 study testing Ketamine in people with Anxiety and Pancreatic Cancer, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
This is a prospective, single center, double blind, randomized, crossover feasibility study of oral ketamine versus placebo for the treatment of anxiety in patients with pancreatic cancer currently receiving or within 12 weeks of receiving cancer targeted therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Pancreatic Cancer
- What is being tested?
- Ketamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2022to 30 Mar 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and the willingness to sign a written informed consent.
- Participant has been diagnosed with pancreatic cancer.
- Receiving or within twelve weeks of having received cancer targeted treatment, including surgery, radiation, chemotherapy, immunotherapy, or other cancer targeted therapy.
- Age ≥ 18 years.
- Has moderate to severe anxiety according to the PROMIS Anxiety Short Form 7a and/or PROMIS-29 anxiety module (T-score of > 60).
- Documented adequate liver function within the screening period.
Show all 11Show fewer
- Use of concomitant standard antidepressants targeting anxiety (e.g. SSRIs) is permitted if dose has been the same for at least 12 weeks prior to study entry and patient still meets inclusion #5.
- Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and while receiving study drug. Women of child-bearing potential must have a negative urine or blood pregnancy test at screening. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and study staff immediately.
- Must be able to read and understand English.
- Required not to engage in potentially hazardous activities, such as driving a motor vehicle or operating machinery, after receiving a medication dose until the next day after a restful sleep (as per recommendations with Spravato).
- Agrees to abstain from alcohol use while taking study medication.
Who cannot join
- Initial cancer diagnosis ≤6 weeks prior to Day 0.
- Meets MINI International Neuropsychiatric Interview (MINI Plus), criteria for diagnoses of schizophrenia, bipolar illness, delirium or psychosis.
- Scores ≥ 10 on the Suicidal Risk Assessment (SRA).
- History of allergic reactions or hypersensitivity to ketamine.
- Documented history of severe cardiac insufficiency (NYHA III or IV), with currently uncontrolled and/or unstable cardiac or coronary artery disease.
- Current or recent significant tachyarrhythmia, severe angina, or myocardial ischemia, as assessed by a study physician.
Show all 14Show fewer
- Documented history of poorly controlled hypertension (Systolic Blood Pressure > 180 mmHG or Diastolic Blood Pressure > 100 mmHG twice within a one-month period in last two months), with or without antihypertensives.
- Women who are pregnant or nursing or expect to become pregnant or start nursing during the expected trial duration, and women of childbearing potential who refuse to use contraceptives to prevent childbearing.
- Uncontrolled hypo- or hyperthyroidism, as assessed by a study physician.
- Diagnosis of dementia.
- Treatment with monoamine oxidase inhibitor (MAOI) within 14 days of Day 0.
- Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels) or arteriovenous malformation.
- History of intracerebral hemorrhage.
- Refusal/inability to comply with inclusion criterion #10 (driving restrictions) and inclusion criterion #11 (alcohol abstinence) during study treatment period.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: A Prospective, Single Center, Double Blind, Randomized, Crossover Feasibility Study of Oral Ketamine Versus Placebo for the Treatment of Anxiety in Patients With Pancreatic Cancer
This is a prospective, single center, double blind, randomized, crossover feasibility study of oral ketamine versus placebo for the treatment of anxiety in patients with pancreatic cancer currently receiving or within 12 weeks of receiving cancer targeted therapy. The primary objective is to determine the feasibility of enrolling subjects and treatment adherence. The secondary objectives are to describe the safety and tolerability. Exploratory objectives are to assess the effect of ketamine/placebo on Depression, Anxiety, Physical Function, Pain Interference, Pain Intensity, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities as measured by PROMIS Anxiety Short Form 7a and the PROMIS-29 Profile v2.1 of Patient Reported Outcomes, as well as changes in circulatory inflammatory cytokines, blood glutamine levels, and other biomarkers of anxiety and/or depression.
- Conditions
- Anxiety, Pancreatic Cancer
- Being tested
- Ketamine, Placebo
- Keywords
- ketamine, placebo
- Medical subject headings
- Anxiety Disorders, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar
Weekly oral administration of 0.5mg/kg ketamine for 4 weeks, followed by weekly oral administration of placebo for 4 weeks (separated by a washout period of 2 weeks).
PlaceboDrug
Weekly oral administration of 0.5mg/kg ketamine for 4 weeks, followed by weekly oral administration of placebo for 4 weeks (separated by a washout period of 2 weeks).
PlaceboDrug
Weekly oral administration of placebo for 4 weeks, followed by weekly oral administration of 0.5mg/kg ketamine for 4 weeks (separated by a washout period of 2 weeks).
KetamineDrug
Also called Ketalar
Weekly oral administration of placebo for 4 weeks, followed by weekly oral administration of 0.5mg/kg ketamine for 4 weeks (separated by a washout period of 2 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Ketamine Followed by Placebo | Experimental | Weekly oral administration of 0.5mg/kg ketamine for 4 weeks, followed by weekly oral administration of placebo for 4 weeks (separated by a washout period of 2 weeks). Receives: Drug: Ketamine; Drug: Placebo |
| Arm B: Placebo Followed by Ketamine | Experimental | Weekly oral administration of placebo for 4 weeks, followed by weekly oral administration of 0.5mg/kg ketamine for 4 weeks (separated by a washout period of 2 weeks). Receives: Drug: Placebo; Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of enrolling subjects which will be measured by the proportion of patients dropping out of study for any reason prior to the end of treatment visit.
The following will be collected as part of this feasibility measurement:
- Reasons for dropout.
- Proportion of patients pre-screened that were potentially eligible for study participation.
- Proportion of patients that were potentially eligible who were approached.
- Proportion of approached patients that decline study participation and why.
- Proportion of approached patients that agreed to participate.
- Proportion of approached that were randomized.
- Proportion of patients completing study through End of Treatment visit and each follow-up visit.
Measured: 2 months
Secondary outcomes (2)
To investigate the safety of oral ketamine in patients with pancreatic cancer and anxiety, which will be assessed by the number of adverse events related to study treatment per CTCAE v.5.
Th number of adverse events related to study treatment assessed per CTCAE v.5.
Measured: 3 months
To investigate the tolerability of oral ketamine in patients with pancreatic cancer and anxiety, which will be measured by patient-reported Ketamine Adverse Symptom Checklist and Impact scores.
This is a self-report tool that provides patient rating (none, mild, moderate, severe) of 33 potential side effects of ketamine. The Adverse Symptom Checklist (ASC) is scored 0 (none), mild (1), moderate (2), and severe (3 points). This scale also asks patients to quantify side effect interference in daily activities, also scored the same way (Min value 0, Max Value 3). Therefore, the total score for the ASC has Min value 0, Max 102 where total higher scores mean a worse outcome. The ASC responses will be dichotomized (frequency: 0%-25% vs >25%; intensity: none, mild vs moderate, or greater; burden: none to mild impairment vs moderate or greater impairment) and will be descriptively summarized by each treatment arm at each assessment time point.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start20 Oct 2022
- Primary completion6 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott A. Irwin, MD, PhD, Cedars-Sinai Medical Center
- Investigators
- Scott Irwin, MD, PhD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086250
- Sponsor's protocol ID
- IIT2019-18-IRWIN-KETANX
- Status last verified
- Aug 2026
- First submitted
- 8 Oct 2021
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Center, Double Blind, Randomized, Crossover Feasibility Study of Oral Ketamine Versus Placebo for the Treatment of Anxiety in Patients With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05086250
- Acronym / sponsor ID
- IIT2019-18-IRWIN-KETANX
- Conditions
- Anxiety, Pancreatic Cancer
- Keywords
- ketamine, placebo
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 6 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 20 Oct 2021 (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.
This is a prospective, single center, double blind, randomized, crossover feasibility study of oral ketamine versus placebo for the treatment of anxiety in patients with pancreatic cancer currently receiving or within 12 weeks of receiving cancer targeted therapy. The primary objective is to determine the feasibility of enrolling subjects and treatment adherence. The secondary objectives are to describe the safety and tolerability. Exploratory objectives are to assess the effect of ketamine/placebo on Depression, Anxiety, Physical Function, Pain Interference, Pain Intensity, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities as measured by PROMIS Anxiety Short Form 7a and the PROMIS-29 Profile v2.1 of Patient Reported Outcomes, as well as changes in circulatory inflammatory cytokines, blood glutamine levels, and other biomarkers of anxiety and/or depression.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Ketamine Followed by Placebo | Experimental | Drug: Ketamine, Drug: PlaceboWeekly oral administration of 0.5mg/kg ketamine for 4 weeks, followed by weekly oral administration of placebo for 4 weeks (separated by a washout period of 2 weeks). |
| Arm B: Placebo Followed by Ketamine | Experimental | Drug: Placebo, Drug: KetamineWeekly oral administration of placebo for 4 weeks, followed by weekly oral administration of 0.5mg/kg ketamine for 4 weeks (separated by a washout period of 2 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Ability to understand and the willingness to sign a written informed consent.
- Participant has been diagnosed with pancreatic cancer.
- Receiving or within twelve weeks of having received cancer targeted treatment, including surgery, radiation, chemotherapy, immunotherapy, or other cancer targeted therapy.
- Age ≥ 18 years.
- Has moderate to severe anxiety according to the PROMIS Anxiety Short Form 7a and/or PROMIS-29 anxiety module (T-score of > 60).
Key exclusion criteria (14 listed)
- Initial cancer diagnosis ≤6 weeks prior to Day 0.
- Meets MINI International Neuropsychiatric Interview (MINI Plus), criteria for diagnoses of schizophrenia, bipolar illness, delirium or psychosis.
- Scores ≥ 10 on the Suicidal Risk Assessment (SRA).
- History of allergic reactions or hypersensitivity to ketamine.
- Documented history of severe cardiac insufficiency (NYHA III or IV), with currently uncontrolled and/or unstable cardiac or coronary artery disease.
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: KetalarWeekly oral administration of 0.5mg/kg ketamine for 4 weeks, followed by weekly oral administration of placebo for 4 weeks (separated by a washout period of 2 weeks). | Drug | Arm A: Ketamine Followed by Placebo |
| PlaceboWeekly oral administration of 0.5mg/kg ketamine for 4 weeks, followed by weekly oral administration of placebo for 4 weeks (separated by a washout period of 2 weeks). | Drug | Arm A: Ketamine Followed by Placebo |
| PlaceboWeekly oral administration of placebo for 4 weeks, followed by weekly oral administration of 0.5mg/kg ketamine for 4 weeks (separated by a washout period of 2 weeks). | Drug | Arm B: Placebo Followed by Ketamine |
| KetamineAlso: KetalarWeekly oral administration of placebo for 4 weeks, followed by weekly oral administration of 0.5mg/kg ketamine for 4 weeks (separated by a washout period of 2 weeks). | Drug | Arm B: Placebo Followed by Ketamine |
Primary outcome
Feasibility of enrolling subjects which will be measured by the proportion of patients dropping out of study for any reason prior to the end of treatment visit.
Time frame: 2 months
The following will be collected as part of this feasibility measurement: * Reasons for dropout. * Proportion of patients pre-screened that were potentially eligible for study participation. * Proportion of patients that were potentially eligible who were approached. * Proportion of approached patients that decline study participation and why. * Proportion of approached patients that agreed to participate. * Proportion of approached that were randomized. * Proportion of patients completing study through End of Treatment visit and each follow-up visit.
2 secondary outcomes
To investigate the safety of oral ketamine in patients with pancreatic cancer and anxiety, which will be assessed by the number of adverse events related to study treatment per CTCAE v.5.
Time frame: 3 months
To investigate the tolerability of oral ketamine in patients with pancreatic cancer and anxiety, which will be measured by patient-reported Ketamine Adverse Symptom Checklist and Impact scores.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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.
Scott Irwin, MD, PhD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ketamine in people with Anxiety and Pancreatic Cancer, run by Cedars-Sinai Medical Center 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 11 inclusion and 14 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: finished, as of the sponsor's last update on 13 Aug 2026. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of enrolling subjects which will be measured by the proportion of patients dropping out of study for any reason prior to the end of treatment visit. (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2026.