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CompletedNCT03410446Updated May 6, 2022

Study of Ketamine for Depression in Cancer Patients Receiving Palliative Care

A Phase 2 interventional study of Ketamine Hydrochloride in Depression, Cancer and Palliative Care, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-06.

Sponsored by University Health Network, Toronto · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Depression
  • Cancer
  • Palliative Care
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Ketamine

    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

    Drug: Ketamine Hydrochloride

Interventions

  • DrugKetamine Hydrochloride

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

05

What researchers measure

Primary outcomes

  1. Greater than 25% of participants achieving a clinical response

    Montgomery-Åsberg Depression Rating Scale (MADRS) score decreasing by \>50%

    Time frame: Day 8

06

Study locations

1 site
  • Princess Margaret Cancer Centre
    Toronto, Ontario M5G 2M9, Canada
07

Registry details

Key details

Study ID
NCT03410446
Lead sponsor
University Health Network, Toronto
Responsible party
Sponsor
First posted
Jan 25, 2018
Start date
Jul 16, 2018
Primary completion
Nov 27, 2021
Completion
Nov 27, 2021
Last update
May 6, 2022

Study contacts

Madeline Li, M.D.
principal investigator · Princess Margaret Cancer Centre

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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