search
Back to results

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

Primary Purpose

Major Depressive Disorder, Advanced Cancer

Status
Completed
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
Ketamine
Placebo
Sponsored by
Instituto Nacional de Cancerologia de Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Instituto Nacional de Cancerología (INCan)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ketamine

Placebo

Arm Description

Patients allocated to the ketamine arm will receive 0.5 mg/kg of ketamine every week administered intravenously for 4 weeks.

Patients allocated to the ketamine arm will receive 0.5 mg/kg of ketamine every week administered intravenously for 4 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 16, 2020
Last Updated
September 26, 2023
Sponsor
Instituto Nacional de Cancerologia de Mexico
search

1. Study Identification

Unique Protocol Identification Number
NCT04471818
Brief Title
Ketamine or Placebo in Patients With Major Depression and Advanced Cancer
Acronym
KODIAC
Official Title
Ketamine Versus Placebo as Adjuvant Treatment for Major Depressive Disorder and Wish to Hasten Death in Advanced Cancer Patients Undergoing Palliative Care
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 19, 2019 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
July 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Cancerologia de Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Advanced Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine
Arm Type
Experimental
Arm Description
Patients allocated to the ketamine arm will receive 0.5 mg/kg of ketamine every week administered intravenously for 4 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients allocated to the ketamine arm will receive 0.5 mg/kg of ketamine every week administered intravenously for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
Ketamine (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study
Primary Outcome Measure Information:
Title
Brief Edinburg Depression Scale (BEDS) score
Description
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.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Instituto Nacional de Cancerología (INCan)
City
Mexico City
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

Ketamine or Placebo in Patients With Major Depression and Advanced Cancer

We'll reach out to this number within 24 hrs