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Study of Ketamine for Depression in Cancer Patients Receiving Palliative Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03410446
Recruitment Status : Recruiting
First Posted : January 25, 2018
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Depression Cancer Palliative Care Drug: Ketamine Hydrochloride Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open-label Clinical Trial of Intranasal Ketamine for Depression in Patients With Cancer Receiving Palliative Care (INKeD-PC Study)
Actual Study Start Date : July 16, 2018
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : February 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
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
Ketamine is a N-methyl-D-aspartate (NMDA) antagonist.




Primary Outcome Measures :
  1. Greater than 25% of participants achieving a clinical response [ Time Frame: Day 8 ]
    Montgomery-Åsberg Depression Rating Scale (MADRS) score decreasing by >50%



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 between the ages of 18 and 75.
  • Patient is an inpatient of the Princess Margaret Cancer Centre's (PM), including all in-patient units.
  • 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 six months, as determined by the inpatient 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 delegated physician will also be excluded
  • Current symptoms of psychosis or perceptual disturbances of any kind per investigator discretion
  • Pregnancy or breastfeeding women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03410446


Contacts
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Contact: Madeline Li, M.D. 416-946-4501 ext 7505 madeline.li@uhn.ca

Locations
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Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Madeline Li, M.D.    416-946-4501 ext 7505    madeline.li@uhn.ca   
Principal Investigator: Madeline Li, M.D.         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Madeline Li, M.D. Princess Margaret Cancer Centre
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03410446    
Other Study ID Numbers: INKeD-PC
16-5754 ( Other Identifier: UHN REB )
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action