Ketamine or Placebo in Patients With Major Depression and Advanced Cancer

• Status: Recruiting
• Trial end date: 2022-12-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Nacional de Cancerologia de Mexico
• Treatments: Ketamine

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