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Study of Ketamine for Depression in Cancer Patients Receiving Palliative Care

Primary Purpose

Depression, Cancer, Palliative Care

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Ketamine Hydrochloride
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Princess Margaret Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ketamine

Arm Description

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

Outcomes

Primary Outcome Measures

Greater than 25% of participants achieving a clinical response
Montgomery-Åsberg Depression Rating Scale (MADRS) score decreasing by >50%

Secondary Outcome Measures

Full Information

First Posted
December 28, 2017
Last Updated
May 4, 2022
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03410446
Brief Title
Study of Ketamine for Depression in Cancer Patients Receiving Palliative Care
Official Title
A Phase II, Open-label Clinical Trial of Intranasal Ketamine for Depression in Patients With Cancer Receiving Palliative Care (INKeD-PC Study)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 16, 2018 (Actual)
Primary Completion Date
November 27, 2021 (Actual)
Study Completion Date
November 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 severity of depression these patients. Ketamine will be given through the nose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Cancer, Palliative Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Ketamine Hydrochloride
Intervention Description
Ketamine is a N-methyl-D-aspartate (NMDA) antagonist.
Primary Outcome Measure Information:
Title
Greater than 25% of participants achieving a clinical response
Description
Montgomery-Åsberg Depression Rating Scale (MADRS) score decreasing by >50%
Time Frame
Day 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madeline Li, M.D.
Organizational Affiliation
Princess Margaret Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

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Study of Ketamine for Depression in Cancer Patients Receiving Palliative Care

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