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Study of Ketamine for Depression in Cancer Patients Receiving Palliative Care | Clinical Trials | Clareo Health

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Study of Ketamine for Depression in Cancer Patients Receiving Palliative Care

A Phase II, Open-label Clinical Trial of Intranasal Ketamine for Depression in Patients With Cancer Receiving Palliative Care (INKeD-PC Study)

NCT03410446•University Health Network, Toronto

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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

Locations (1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Key Dates

Start Date

July 16, 2018

Primary Completion Date

November 27, 2021

Completion Date

November 27, 2021

Last Updated

May 6, 2022

Enrollment

ACTUAL participants

Conditions

DepressionCancerPalliative Care

Interventions

Ketamine Hydrochloride

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 6, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Ketamine for Depression in Cancer Patients Receiving Palliative Care

Inclusion Criteria

Exclusion Criteria

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