Study of Ketamine for Depression in Cancer Patients Receiving Palliative Care

NCT03410446 | Completed Phase 2 DMC

• 2 other identifiers: INKeD-PC16-5754
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Cancer; Palliative Care

Outcome Measures

Primary Outcomes (1)

• Greater than 25% of participants achieving a clinical response

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

  Day 8

Study Arms (1)

Ketamine

EXPERIMENTAL

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

Ketamine Hydrochloride DRUG

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

Ketamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Depression; Neoplasms

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Madeline Li, M.D.

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 25, 2018
• Study Start: July 16, 2018
• Primary Completion: November 27, 2021
• Study Completion: November 27, 2021
• Last Updated: May 6, 2022

Record last verified: 2022-05

Locations

CA (1)