Study of Ketamine for Depression in Cancer Patients Receiving Palliative Care

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03410446

Enrollment

Registered

2018-01-25

Start date

2018-07-16

Completion date

2021-11-27

Last updated

2022-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Depression, Palliative Care

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.

Interventions

DRUGKetamine Hydrochloride

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Greater than 25% of participants achieving a clinical response	Day 8	Montgomery-Åsberg Depression Rating Scale (MADRS) score decreasing by \>50%

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026