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Completed

NCT Number: NCT03410446

Study of Ketamine for Depression in Cancer Patients Receiving Palliative Care

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Cancer Neoplasms Palliative Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketamine Hydrochloride

Drug

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

Primary outcomes

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

    Time frame: Day 8

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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

A Phase II, Open-label Clinical Trial of Intranasal Ketamine for Depression in Patients With Cancer Receiving Palliative Care (INKeD-PC Study)

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 25, 2018
Registry last updated
May 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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