Ketamine or Placebo in Patients With Major Depression and Advanced Cancer (KODIAC)

September 26, 2023 updated by: Oscar Raúl Rodríguez Mayoral, Instituto Nacional de Cancerologia de Mexico

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico
        • Instituto Nacional de Cancerología (INCan)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketamine
Patients allocated to the ketamine arm will receive 0.5 mg/kg of ketamine every week administered intravenously for 4 weeks.
Drug: Ketamine
Ketamine (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study
Placebo Comparator: Placebo
Patients allocated to the ketamine arm will receive 0.5 mg/kg of ketamine every week administered intravenously for 4 weeks.
Other: Placebo
Placebo (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cancerologia de Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2019

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

July 30, 2023

Study Registration Dates

First Submitted

June 16, 2020

First Submitted That Met QC Criteria

July 13, 2020

First Posted (Actual)

July 15, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • (019/024/CPI) /CEI/1332/18)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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