Ketamine or Placebo in Patients With Major Depression and Advanced Cancer

NCT04471818 | Completed Phase 1

• 1 other identifier: (019/024/CPI) /CEI/1332/18)
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Advanced Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Ketamine

EXPERIMENTAL

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

Drug: Ketamine

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Ketamine DRUG

Ketamine (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study

Ketamine

Placebo OTHER

Placebo (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Cancerologia de Mexico: lead

Study Sites (1)

Instituto Nacional de Cancerología (INCan)

Mexico City, Mexico

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head psychiatrist at the Palliative Care Unit of the National Cancer Institute (INCan, Mexico)

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: July 15, 2020
• Study Start: September 19, 2019
• Primary Completion: June 1, 2023
• Study Completion: July 30, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

ME (1)