Ketamine or Placebo in Patients With Major Depression and Advanced Cancer

Major depression (MD) is a psychiatric disorder characterized by a persistent feeling of sadness, anhedonia or a decreased perception of pleasurable experiences, as well as appetite alterations and weight variations, sleep disorders, altered psychomotor skills, fatigue, guilt, decreased self-worth, suicidal thoughts and difficulty concentrating in a task (1).

MD is a frequent complication in patients who are diagnosed with advanced cancer.

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Key information

Conditions

Major Depressive Disorder Advanced Cancer Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Instituto Nacional de Cancerología (INCan)

Mexico City, Mexico

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Age: 18 to 65 years of age
Sex: Male or female
Major depressive disorder (MDD) diagnosis as per Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
Palliative stage cancer diagnosis (advanced-disease stage)
Who can read and write in spanish
Eastern Cooperative Oncology Group (ECOG) 0-2
Karnofsky ≥ 50
Palliative prognostic index A
Not currently undergoing systemic oncologic treatment
Patients who agree to participate in the study by signing an informed consent.

Exclusion criteria

Comorbidities including other psychiatric diseases (additional to MDD, generalized anxiety or panic disorder).
Magnetic resonance or computerized tomography with major structural alterations.
Pregnant or breastfeeding women.
Patients with hypersensitivity to ketamine
Cardiac insufficiency
Patients with a history of psychosis
Patients with first-degree relatives with a history of psychosis
Patients with uncontrolled glaucoma
Current neurological illness

Treatment and study plan

ketamine

Drug

Ketamine (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study

Placebo

Other

Placebo (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study

Primary outcomes

Brief Edinburg Depression Scale (BEDS) score

Time frame: 3 weeks

Scale to assess depression validated in cancer patients. For the BEDS scale, 6 items are included and scored, maximum score is 18 and minimum score is 0. Patients screened for depression are considered cases when scoring ≥7 in this scale.

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Cancerologia de Mexico

Other

Registry information

Official study title

Ketamine Versus Placebo as Adjuvant Treatment for Major Depressive Disorder and Wish to Hasten Death in Advanced Cancer Patients Undergoing Palliative Care

Acronym: KODIAC

Important dates

Study start: 2019
Primary completion: 2023
Study completion: 2023
First posted: Jul 15, 2020
Registry last updated: Sep 28, 2023

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.

Published trials that share one or more normalized conditions with this study.

Completed