Ketamine or Placebo in Patients With Major Depression and Advanced Cancer

Phase 1

Completed

• Conditions: Major Depressive Disorder; Advanced Cancer
• Interventions: Other: Placebo; Drug: Ketamine

• Registration Number: NCT04471818
• Lead Sponsor: Instituto Nacional de Cancerologia de Mexico

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-19
• Study First Submitted: 2020-06-16
• Study First Submitted QC: 2020-07-13
• Study First Posted: 2020-07-15
• Primary Completion: 2023-06-01
• Study Completion: 2023-07-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients allocated to the ketamine arm will receive 0.5 mg/kg of ketamine every week administered intravenously for 4 weeks.
Ketamine	Ketamine	Patients allocated to the ketamine arm will receive 0.5 mg/kg of ketamine every week administered intravenously for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Brief Edinburg Depression Scale (BEDS) score	3 weeks	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.

Trial Locations

Locations (1)

Instituto Nacional de Cancerología (INCan); 🇲🇽 Mexico City, Mexico