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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04471818
Other study ID # (019/024/CPI) /CEI/1332/18)
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
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