Ketamine or Placebo in Patients With Major Depression and Advanced Cancer

Instituto Nacional de Cancerologia de Mexico19 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Major Depressive Disorder Advanced Cancer

Interventions

KetamineDRUG

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

PlaceboOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Instituto Nacional de Cancerología (INCan)

Mexico City, Mexico

Outcomes

Primary Outcomes

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.

Time frame: 3 weeks

Data from ClinicalTrials.gov

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