CancerEarly Phase 1NCT02836288
Study of Oral Ketamine Versus Placebo for Treating Depression in Patients Undergoing Treatment for Cancer
A Early Phase 1 study testing Ketamine in people with Cancer and Depression, run by Scott A. Irwin, MD, PhD at 1 site in United States.
Trial summary
The primary purpose of this study is to see if it is safe to give patients with cancer a low dose of the FDA approved anesthetic drug ketamine at the same time they receive radiation, chemotherapy, and/or surgery for their cancer treatment to treat depression and its effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Depression
- 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
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2016to 29 May 2018
- 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.
- Subject receiving or within twelve weeks of having received curative intent cancer treatment with radiation and/or chemotherapy
- Age ≥ 18 years.
- Has moderate to severe depression according to Quick Inventory of Depressive Symptomatology-Self Rated 16 (QIDS-SR-16) scores of ≥ 11 AND a Hospital Anxiety and Depression Scale (HADS) Depression subscale score of ≥ 8.
- Documented adequate liver function within the screening period as defined by:
- ALT < 5 X institutional upper limit of normal (ULN)
Show all 12Show fewer
- AST < 5 X institutional ULN
- Total bilirubin < 5 X institutional ULN
- Both men and women of all races and ethnic groups are eligible for this trial.
- Use of other antidepressants is permitted if dose has been the same for at least 12 weeks prior to study entry and still meet inclusion #4.
- 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 for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating and the study physician immediately. Urine pregnancy testing will be done throughout the trial for women of childbearing potential.
- Must read and understand English fluently.
Who cannot join
- Receiving another investigational agent on a clinical trial that prohibits participation in other studies of investigational agents.
- Meets MINI International Neuropsychiatric Interview (MINI Plus), criteria for diagnoses of schizophrenia, bipolar illness, delirium or psychosis.
- Has high Suicidal Risk Assessment (SRA) scores ≥ 10.
- Use of monoamine oxidase inhibitors within 14 days of study entry.
- History of allergic reactions or hypersensitivity to ketamine.
- Documented history of severe cardiac insufficiency (NYHA III or IV), with uncontrolled and/or unstable cardiac or coronary artery disease.
Show all 10Show fewer
- Documented history of significant tachyarrhythmia, severe angina, or myocardial ischemia
- Documented history of poorly controlled hypertension (Systolic Blood Pressure > 180 mmHG or Diastolic Blood Pressure > 100 mmHG), with or without antihypertensives.
- If a woman is or becomes pregnant or is nursing at any time before or during the treatment period, she will be excluded from the study.
- Score of ≥ 8 on the WHO Alcohol Use Disorders Identification Test (AUDIT)
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 Randomized, Double Blind, Feasibility Study of Oral Ketamine Versus Placebo for Treating Depression in Patients With Cancer
The primary purpose of this study is to see if it is safe to give patients with cancer a low dose of the FDA approved anesthetic drug ketamine at the same time they receive radiation, chemotherapy, and/or surgery for their cancer treatment to treat depression and its effects. Researchers would also like to see if giving ketamine at the same time as cancer treatment is practical and reasonably acceptable to the patient.
Depression has many negative consequences for outcomes in those with cancer. It causes delayed treatments, increases in hospital lengths of stay, decreases in treatment adherence, poorer self-care, and decreased quality of life, even at 3 years post treatment. The presence of depression is the number one predictor of incomplete treatment and difficulty with rehabilitation. Therefore, investigators would also like to see if it is feasible to give patients ketamine during their routine cancer treatment treat depression and its negative effects on cancer treatment outcomes, and also help with anxiety, pain, and quality of life. The study will also use a placebo to compare to the good and/or bad effects of ketamine. A placebo is not an active drug and it will be look the same as ketamine, as a liquid to be taken by mouth.
Ketamine is approved by the U.S. Food and Drug Administration (FDA) as a general anesthetic by itself for some diagnostic and surgical procedures or combined with other general anesthetic agents. It has also been shown to reduce cancer pain. Ketamine is considered experimental in this study because it is not approved by the FDA for the treatment of depression.
Read the detailed description
This is a prospective, single center, double blind, randomized, two-arm feasibility study of oral ketamine versus placebo for the treatment of depression in depressed patients with cancer undergoing curative intent cancer therapy. Approximately 20 patients with cancer about to undergo cancer therapy will be randomized 1:1 to receive study treatment with one of the following regimens:
Arm A: nightly oral administration of 1.0 mg/kg ketamine Arm B: nightly oral administration of placebo (after completion of Arm B, patients will have the option to receive a nightly oral administration of 1.0 mg/kg ketamine and follow study procedures over again)
Consenting patients will undergo screening procedures, and if eligible, a baseline interview and brief questionnaires regarding depression, mental and emotional health, and quality of life assessments.
Study treatment will be administered for 12 weeks unless the patient experiences unacceptable toxicities, exhibits moderate to severe depressive symptoms, or withdraws consent. Patients on the placebo treatment arm will have the option to receive ketamine and follow all study procedures over again with the ketamine drug after completion of the placebo treatment.
Patients will be asked to complete psychosocial measurements every two weeks while on study treatment and monthly during a five-month follow-up period.
- Conditions
- Cancer, Depression
- Being tested
- Ketamine, Placebo
- Keywords
- Ketamine, Treatment of Depression
- Medical subject headings
- Neoplasms, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar
Ketamine 1.0 mg/kg mixed with syrup will be given by mouth once a day for 12 weeks.
PlaceboOther
Placebo syrup will be given by mouth once a day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | Oral ketamine 1.0 mg/kg mixed with syrup Receives: Drug: Ketamine |
| Placebo | Placebo comparator | Oral placebo (syrup) Receives: Other: Placebo |
| Ketamine after placebo | Experimental | Optional oral Ketamine 1.0 mg/kg mixed with syrup for patients on placebo arm after 12 week treatment is completed. Receives: Drug: Ketamine; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients pre-screened that were potentially eligible for study participation.
Measured: 24 months
Proportion of patients that were potentially eligible who were approached.
Measured: 24 months
Proportion of approached patients that decline study participation and why.
Measured: 24 months
Proportion of approached patients that agreed to participate
Measured: 24 months
Proportion of approached that were randomized.
Measured: 24 months
Proportions of patients discontinuing prematurely from study treatment for any reason, including side effects attributed to ketamine or side effects attributed to placebo, documenting reasons for dropout.
Measured: 24 months
Proportion of patients evaluable.
Measured: 24 months
Secondary outcomes (3)
Adverse events related to study treatment.
Measured: 10 months
Patient-reported Frequency, Intensity and Burden of Side Effects (FIBSER) scores.
Measured: 10 months
Treatment expectancy and satisfaction as measured by the credibility/expectancy questionnaire (CEQ).
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study start20 Dec 2016
- Primary completion29 May 2018
- Study completion29 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scott A. Irwin, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor-investigator, Scott A. Irwin, MD, PhD, Cedars-Sinai Medical Center
- Investigators
- Scott Irwin, MD, PhD, Principal investigator, Cedars-Sinal Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836288
- Sponsor's protocol ID
- IIT2015-23-IRWIN-KETTREAT
- Status last verified
- Nov 2018
- First submitted
- 14 Jul 2016
- Last updated
- 6 Nov 2018
- 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 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Feasibility Study of Oral Ketamine Versus Placebo for Treating Depression in Patients With Cancer
- ClinicalTrials.gov ID
- NCT02836288
- Acronym / sponsor ID
- IIT2015-23-IRWIN-KETTREAT
- Conditions
- Cancer, Depression
- Keywords
- Ketamine, Treatment of Depression
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Scott A. Irwin, MD, PhDUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- 20 Dec 2016 (actual)
- Primary completion
- 29 May 2018 (actual)
- Study completion
- 29 May 2018 (actual)
- First posted
- 19 Jul 2016 (estimated)
- 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 primary purpose of this study is to see if it is safe to give patients with cancer a low dose of the FDA approved anesthetic drug ketamine at the same time they receive radiation, chemotherapy, and/or surgery for their cancer treatment to treat depression and its effects. Researchers would also like to see if giving ketamine at the same time as cancer treatment is practical and reasonably acceptable to the patient.
Depression has many negative consequences for outcomes in those with cancer. It causes delayed treatments, increases in hospital lengths of stay, decreases in treatment adherence, poorer self-care, and decreased quality of life, even at 3 years post treatment. The presence of depression is the number one predictor of incomplete treatment and difficulty with rehabilitation. Therefore, investigators would also like to see if it is feasible to give patients ketamine during their routine cancer treatment treat depression and its negative effects on cancer treatment outcomes, and also help with anxiety, pain, and quality of life. The study will also use a placebo to compare to the good and/or bad effects of ketamine. A placebo is not an active drug and it will be look the same as ketamine, as a liquid to be taken by mouth.
Ketamine is approved by the U.S. Food and Drug Administration (FDA) as a general anesthetic by itself for some diagnostic and surgical procedures or combined with other general anesthetic agents. It has also been shown to reduce cancer pain. Ketamine is considered experimental in this study because it is not approved by the FDA for the treatment of depression.
Detailed description
This is a prospective, single center, double blind, randomized, two-arm feasibility study of oral ketamine versus placebo for the treatment of depression in depressed patients with cancer undergoing curative intent cancer therapy. Approximately 20 patients with cancer about to undergo cancer therapy will be randomized 1:1 to receive study treatment with one of the following regimens:
Arm A: nightly oral administration of 1.0 mg/kg ketamine Arm B: nightly oral administration of placebo (after completion of Arm B, patients will have the option to receive a nightly oral administration of 1.0 mg/kg ketamine and follow study procedures over again)
Consenting patients will undergo screening procedures, and if eligible, a baseline interview and brief questionnaires regarding depression, mental and emotional health, and quality of life assessments.
Study treatment will be administered for 12 weeks unless the patient experiences unacceptable toxicities, exhibits moderate to severe depressive symptoms, or withdraws consent. Patients on the placebo treatment arm will have the option to receive ketamine and follow all study procedures over again with the ketamine drug after completion of the placebo treatment.
Patients will be asked to complete psychosocial measurements every two weeks while on study treatment and monthly during a five-month follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: KetamineOral ketamine 1.0 mg/kg mixed with syrup |
| Placebo | Placebo comparator | Other: PlaceboOral placebo (syrup) |
| Ketamine after placebo | Experimental | Drug: Ketamine, Other: PlaceboOptional oral Ketamine 1.0 mg/kg mixed with syrup for patients on placebo arm after 12 week treatment is completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Ability to understand and the willingness to sign a written informed consent.
- Subject receiving or within twelve weeks of having received curative intent cancer treatment with radiation and/or chemotherapy
- Age ≥ 18 years.
- Has moderate to severe depression according to Quick Inventory of Depressive Symptomatology-Self Rated 16 (QIDS-SR-16) scores of ≥ 11 AND a Hospital Anxiety and Depression Scale (HADS) Depression subscale score of ≥ 8.
- Documented adequate liver function within the screening period as defined by:
Key exclusion criteria (10 listed)
- Receiving another investigational agent on a clinical trial that prohibits participation in other studies of investigational agents.
- Meets MINI International Neuropsychiatric Interview (MINI Plus), criteria for diagnoses of schizophrenia, bipolar illness, delirium or psychosis.
- Has high Suicidal Risk Assessment (SRA) scores ≥ 10.
- Use of monoamine oxidase inhibitors within 14 days of study entry.
- History of allergic reactions or hypersensitivity to ketamine.
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: KetalarKetamine 1.0 mg/kg mixed with syrup will be given by mouth once a day for 12 weeks. | Drug | Ketamine, Ketamine after placebo |
| PlaceboPlacebo syrup will be given by mouth once a day for 12 weeks. | Other | Ketamine after placebo, Placebo |
Primary outcome
Proportion of patients pre-screened that were potentially eligible for study participation.
Time frame: 24 months
Proportion of patients that were potentially eligible who were approached.
Time frame: 24 months
Proportion of approached patients that decline study participation and why.
Time frame: 24 months
Proportion of approached patients that agreed to participate
Time frame: 24 months
Proportion of approached that were randomized.
Time frame: 24 months
Proportions of patients discontinuing prematurely from study treatment for any reason, including side effects attributed to ketamine or side effects attributed to placebo, documenting reasons for dropout.
Time frame: 24 months
Proportion of patients evaluable.
Time frame: 24 months
3 secondary outcomes
Adverse events related to study treatment.
Time frame: 10 months
Patient-reported Frequency, Intensity and Burden of Side Effects (FIBSER) scores.
Time frame: 10 months
Treatment expectancy and satisfaction as measured by the credibility/expectancy questionnaire (CEQ).
Time frame: 10 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 6 Nov 2018.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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-Sinal 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 Cancer and Depression, run by Scott A. Irwin, MD, PhD 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 12 inclusion and 10 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 6 Nov 2018. 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?
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?
Proportion of patients pre-screened that were potentially eligible for study participation. (time frame: 24 months). The study lists 7 primary outcomes in all. 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 6 Nov 2018.