Status:
COMPLETED
Study of Ketamine for Depression in Cancer Patients Receiving Palliative Care
Lead Sponsor:
University Health Network, Toronto
Conditions:
Depression
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2021
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03410446
Start Date
July 16 2018
End Date
November 27 2021
Last Update
May 6 2022
Active Locations (1)
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1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9