DepressionPhase 2NCT03410446
Study of Ketamine for Depression in Cancer Patients Receiving Palliative Care
A Phase 2 study testing Ketamine Hydrochloride in people with Depression and Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a phase 2 study of the drug ketamine for the treatment of depression in cancer patients receiving palliative care. The purpose of this study is to see how useful the drug is at decreasing the severity of depression these patients. Ketamine will be given through the nose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Cancer, Palliative Care
- What is being tested?
- Ketamine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- 16 Jul 2018to 27 Nov 2021
- Phase
- Phase 2
- 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
- Provide written, voluntary informed consent prior to study enrollment. Participants must be capable of consenting to treatment as substitute decision makers will not be allowed to consent to the study on their behalf
- Males and females ≥ 18 years of age
- Patient is receiving palliative care at Princess Margaret Cancer Centre (PM) including all in-patient units and outpatients
- Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Major Depressive Disorder (MDD), with a current Major Depressive Episode (MDE)
- Depression severity must be in the moderate to severe range, as determined by a Montgomery-Åsberg Depression Rating Scale (MADRS) score greater than or equal to 20
- Participants must have a confirmed diagnosis of cancer and an estimated life expectancy of less than twelve months, as determined by the palliative care physician
Who cannot join
- Presence of delirium or suspected delirium
- Severe hypertension or severe cardiac decompensation
- Previous stroke history
- History of intolerability, hypersensitivity or allergy to ketamine
- Patients with bipolar disorder, psychotic disorders, substance use disorders or active suicidality based on a Mini-International Neuropsychiatric Interview (MINI) conducted by a delegated physician will also be excluded
- Current symptoms of psychosis or perceptual disturbances of any kind per investigator discretion
- Pregnancy or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Open-label Clinical Trial of Intranasal Ketamine for Depression in Patients With Cancer Receiving Palliative Care (INKeD-PC Study)
This is a phase 2 study of the drug ketamine for the treatment of depression in cancer patients receiving palliative care. The purpose of this study is to see how useful the drug is at decreasing the severity of depression these patients. Ketamine will be given through the nose.
- Conditions
- Depression, Cancer, Palliative Care
- Being tested
- Ketamine Hydrochloride
- Medical subject headings
- Depression, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine HydrochlorideDrug
Ketamine is a N-methyl-D-aspartate (NMDA) antagonist.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | Three doses of ketamine will be given intranasal:
* Dose 1 will be 50 mg on Day 1
* Dose 2 will be between 50-100 mg on Day 4
* Dose 3 will be between 50-150 mg on Day 7 Receives: Drug: Ketamine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Greater than 25% of participants achieving a clinical response
Montgomery-Åsberg Depression Rating Scale (MADRS) score decreasing by >50%
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start16 Jul 2018
- Primary completion27 Nov 2021
- Study completion27 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Madeline Li, M.D., Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410446
- Sponsor's protocol ID
- INKeD-PC
- Other IDs
- 16-5754
- Status last verified
- May 2022
- First submitted
- 28 Dec 2017
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label Clinical Trial of Intranasal Ketamine for Depression in Patients With Cancer Receiving Palliative Care (INKeD-PC Study)
- ClinicalTrials.gov ID
- NCT03410446
- Acronym / sponsor ID
- INKeD-PC
- Conditions
- Depression, Cancer, Palliative Care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 27 Nov 2021 (actual)
- Study completion
- 27 Nov 2021 (actual)
- First posted
- 25 Jan 2018 (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 phase 2 study of the drug ketamine for the treatment of depression in cancer patients receiving palliative care. The purpose of this study is to see how useful the drug is at decreasing the severity of depression these patients. Ketamine will be given through the nose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: Ketamine HydrochlorideThree doses of ketamine will be given intranasal: * Dose 1 will be 50 mg on Day 1 * Dose 2 will be between 50-100 mg on Day 4 * Dose 3 will be between 50-150 mg on Day 7 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provide written, voluntary informed consent prior to study enrollment. Participants must be capable of consenting to treatment as substitute decision makers will not be allowed to consent to the study on their behalf
- Males and females ≥ 18 years of age
- Patient is receiving palliative care at Princess Margaret Cancer Centre (PM) including all in-patient units and outpatients
- Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Major Depressive Disorder (MDD), with a current Major Depressive Episode (MDE)
- Depression severity must be in the moderate to severe range, as determined by a Montgomery-Åsberg Depression Rating Scale (MADRS) score greater than or equal to 20
Key exclusion criteria (7 listed)
- Presence of delirium or suspected delirium
- Severe hypertension or severe cardiac decompensation
- Previous stroke history
- History of intolerability, hypersensitivity or allergy to ketamine
- Patients with bipolar disorder, psychotic disorders, substance use disorders or active suicidality based on a Mini-International Neuropsychiatric Interview (MINI) conducted by a delegated physician will also be excluded
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 |
|---|---|---|
| Ketamine HydrochlorideKetamine is a N-methyl-D-aspartate (NMDA) antagonist. | Drug | Ketamine |
Primary outcome
Greater than 25% of participants achieving a clinical response
Time frame: Day 8
Montgomery-Åsberg Depression Rating Scale (MADRS) score decreasing by >50%
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 May 2022.
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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.
Madeline Li, M.D. principal investigator
Princess Margaret Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketamine Hydrochloride in people with Depression and Cancer, run by University Health Network, Toronto at 1 site in Canada.
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 6 inclusion and 7 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 May 2022. 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 Canada. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Greater than 25% of participants achieving a clinical response (time frame: Day 8). 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 May 2022.