Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT04471818
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2020-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ketamine or Placebo in Patients With Major Depression and Advanced Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-26', 'studyFirstSubmitDate': '2020-06-16', 'studyFirstSubmitQcDate': '2020-07-13', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brief Edinburg Depression Scale (BEDS) score', 'timeFrame': '3 weeks', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Major Depressive Disorder', 'Advanced Cancer']}, 'descriptionModule': {'briefSummary': '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).\n\nMD is a frequent complication in patients who are diagnosed with advanced cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 18 to 65 years of age\n2. Sex: Male or female\n3. Major depressive disorder (MDD) diagnosis as per Diagnostic and Statistical Manual of Mental Disorders (DSM-5).\n4. Palliative stage cancer diagnosis (advanced-disease stage)\n5. Who can read and write in spanish\n6. Eastern Cooperative Oncology Group (ECOG) 0-2\n7. Karnofsky ≥ 50\n8. Palliative prognostic index A\n9. Not currently undergoing systemic oncologic treatment\n10. Patients who agree to participate in the study by signing an informed consent.\n\nExclusion Criteria:\n\n1. Comorbidities including other psychiatric diseases (additional to MDD, generalized anxiety or panic disorder).\n2. Magnetic resonance or computerized tomography with major structural alterations.\n3. Pregnant or breastfeeding women.\n4. Patients with hypersensitivity to ketamine\n5. Cardiac insufficiency\n6. Patients with a history of psychosis\n7. Patients with first-degree relatives with a history of psychosis\n8. Patients with uncontrolled glaucoma\n9. Current neurological illness'}, 'identificationModule': {'nctId': 'NCT04471818', 'acronym': 'KODIAC', 'briefTitle': 'Ketamine or Placebo in Patients With Major Depression and Advanced Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Nacional de Cancerologia de Mexico'}, 'officialTitle': 'Ketamine Versus Placebo as Adjuvant Treatment for Major Depressive Disorder and Wish to Hasten Death in Advanced Cancer Patients Undergoing Palliative Care', 'orgStudyIdInfo': {'id': '(019/024/CPI) /CEI/1332/18)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketamine', 'description': 'Patients allocated to the ketamine arm will receive 0.5 mg/kg of ketamine every week administered intravenously for 4 weeks.', 'interventionNames': ['Drug: Ketamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients allocated to the ketamine arm will receive 0.5 mg/kg of ketamine every week administered intravenously for 4 weeks.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'description': 'Ketamine (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study', 'armGroupLabels': ['Ketamine']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Instituto Nacional de Cancerología (INCan)', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Nacional de Cancerologia de Mexico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head psychiatrist at the Palliative Care Unit of the National Cancer Institute (INCan, Mexico)', 'investigatorFullName': 'Oscar Raúl Rodríguez Mayoral', 'investigatorAffiliation': 'Instituto Nacional de Cancerologia de Mexico'}}}}