Ketamine or Placebo in Patients With Major Depression and Advanced Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Ketamine Versus Placebo as Adjuvant Treatment for Major Depressive Disorder and Wish to Hasten Death in Advanced Cancer Patients Undergoing Palliative Care

Conditions
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Advanced Cancer, Major Depressive Disorder

Intervention / Treatment
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* Drug: Ketamine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine<br>Patients allocated to the ketamine arm will receive 0.5 mg/kg of ketamine every week administered intravenously for 4 weeks. | Drug: Ketamine<br>* Ketamine (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study<br>|
| Placebo Comparator: Placebo<br>Patients allocated to the ketamine arm will receive 0.5 mg/kg of ketamine every week administered intravenously for 4 weeks. | Other: Placebo<br>* Placebo (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |