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

Sponsor

Instituto Nacional de Cancerologia de Mexico (Other)

Overall Status

Recruiting

CT.gov ID

NCT04471818

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Nov 19, 2019

Anticipated Primary Completion Date :

Jan 19, 2023

Anticipated Study Completion Date :

Jul 19, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Brief Edinburg Depression Scale (BEDS) score [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto Nacional de Cancerología (INCan)	Mexico City		Mexico

Sponsors and Collaborators

Instituto Nacional de Cancerologia de Mexico

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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: