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COMPLETEDPHASE1/PHASE2

Ketamine or Placebo in Patients With Major Depression and Advanced Cancer

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

NCT04471818•Instituto Nacional de Cancerologia de Mexico

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

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

Exclusion Criteria

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

Locations (1)

Instituto Nacional de Cancerología (INCan)

Mexico City, Mexico

Key Dates

Start Date

September 19, 2019

Primary Completion Date

June 1, 2023

Completion Date

July 30, 2023

Last Updated

September 28, 2023

Enrollment

ACTUAL participants

Conditions

Major Depressive DisorderAdvanced Cancer

Interventions

Ketamine

DRUG

Placebo

OTHER

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 28, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Ketamine or Placebo in Patients With Major Depression and Advanced Cancer

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

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