Status:
COMPLETED
Ketamine or Placebo in Patients With Major Depression and Advanced Cancer
Lead Sponsor:
Instituto Nacional de Cancerologia de Mexico
Conditions:
Major Depressive Disorder
Advanced Cancer
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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 we...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2023
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04471818
Start Date
September 19 2019
End Date
July 30 2023
Last Update
September 28 2023
Active Locations (1)
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1
Instituto Nacional de Cancerología (INCan)
Mexico City, Mexico