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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03410446
Other study ID # INKeD-PC
Secondary ID 16-5754
Status Completed
Phase Phase 2
First received
Last updated
Start date July 16, 2018
Est. completion date November 27, 2021

Study information

Verified date May 2022
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date November 27, 2021
Est. primary completion date November 27, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ketamine Hydrochloride
Ketamine is a N-methyl-D-aspartate (NMDA) antagonist.

Locations

Country Name City State
Canada Princess Margaret Cancer Centre Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Greater than 25% of participants achieving a clinical response Montgomery-Åsberg Depression Rating Scale (MADRS) score decreasing by >50% Day 8
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