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

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: Major Depressive Disorder; Advanced Cancer
• Intervention / Treatment: Drug: Ketamine; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Oscar Rodríguez, MD; Phone Number: 55 5628 0400; Email: oscroma@gmail.com

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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

• Sponsor: Instituto Nacional de Cancerologia de Mexico

Study record dates

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: Behavioral Symptoms; Mental Disorders; Mood Disorders; Neoplasms; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• 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