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CompletedPhase 2

Study of Ketamine for Depression in Cancer Patients Receiving Palliative Care

NCT03410446 · University Health Network, Toronto

Closed to entry
Status
Not accepting participants
Phase 2
Phase
22
Target enrolment
1
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Greater than 25% of participants achieving a clinical response

    Measured over Day 8

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
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

Where

1 study site

FacilityCityRegionCountry
Princess Margaret Cancer CentreTorontoOntarioCanada

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT03410446 on ClinicalTrials.gov →

Last updated in the registry 2022-05-06. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits