Clinical trial

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

Name
(019/024/CPI) /CEI/1332/18)
Description
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.
Trial arms
Trial start
2019-09-19
Estimated PCD
2023-06-01
Trial end
2023-07-30
Status
Completed
Phase
Early phase I
Treatment
Ketamine
Ketamine (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study
Arms:
Ketamine
Placebo
Placebo (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study
Arms:
Placebo
Size
19
Primary endpoint
Brief Edinburg Depression Scale (BEDS) score
3 weeks
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 19, 'type': 'ACTUAL'}}
Updated at
2023-09-28

1 organization

1 drug

2 indications

Indication
Advanced Cancer