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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04471818
Recruitment Status : Recruiting
First Posted : July 15, 2020
Last Update Posted : March 16, 2022
Sponsor:
Information provided by (Responsible Party):
Oscar Raúl Rodríguez Mayoral, Instituto Nacional de Cancerologia de Mexico

Brief 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.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Advanced Cancer Drug: Ketamine Other: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Ketamine Versus Placebo as Adjuvant Treatment for Major Depressive Disorder and Wish to Hasten Death in Advanced Cancer Patients Undergoing Palliative Care
Actual Study Start Date : November 19, 2019
Estimated Primary Completion Date : June 19, 2022
Estimated Study Completion Date : December 19, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04471818


Contacts
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Contact: Oscar Rodríguez, MD 55 5628 0400 oscroma@gmail.com

Locations
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Mexico
Instituto Nacional de Cancerología (INCan) Recruiting
Mexico City, Mexico
Contact: Oscar Rodríguez Mayoral, MD    55 5628 0400    oscroma@gmail.com   
Sponsors and Collaborators
Instituto Nacional de Cancerologia de Mexico
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Responsible Party: Oscar Raúl Rodríguez Mayoral, Head psychiatrist at the Palliative Care Unit of the National Cancer Institute (INCan, Mexico), Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier: NCT04471818    
Other Study ID Numbers: (019/024/CPI) /CEI/1332/18)
First Posted: July 15, 2020    Key Record Dates
Last Update Posted: March 16, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action