Ketamine or Placebo in Patients With Major Depression and Advanced Cancer

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04471818

Acronym

KODIAC

Enrollment

Registered

2020-07-15

Start date

2019-09-19

Completion date

2023-07-30

Last updated

2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cancer, Major Depressive Disorder

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.

Interventions

DRUGKetamine

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

OTHERPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026