Ketamine or Placebo in Patients With Major Depression and Advanced Cancer

Major Depressive Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04471818
• Other study ID #: (019/024/CPI) /CEI/1332/18)
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 19, 2019
• Est. completion date: July 30, 2023

Study information

• Verified date: September 2023
• Source: Instituto Nacional de Cancerologia de Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 30, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Neoplasms

Intervention

Drug:
• Ketamine
Ketamine (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study

Other:
• Placebo
Placebo (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Cancerología (INCan)	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Cancerologia de Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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