Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-03 @ 10:17 AM
Study NCT ID:
NCT01868802
Status:
UNKNOWN
Last Update Posted:
2015-03-17
First Post:
2013-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D061218', 'term': 'Depressive Disorder, Treatment-Resistant'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'lastUpdateSubmitDate': '2015-03-13', 'studyFirstSubmitDate': '2013-05-24', 'studyFirstSubmitQcDate': '2013-06-04', 'lastUpdatePostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in baseline HDRS Score', 'timeFrame': '20 minutes before and 40 minutes after ketamine infusion.', 'description': 'The Hamilton Depression Rating Scale (HDRS) baseline score will be measured 20 minutes before ketamine infusion. After 40 minutes post-infusion, a second HDRS score will be obtained.'}, {'measure': 'Daily change in HDRS post-ketamine infusion.', 'timeFrame': '1,2,3,4,5,6 and 7. Days after ketamine infusion', 'description': 'On a daily basis, from day 1-7 post-ketamine infusion, changes in HDRS score will be measured during the daily psychiatric evaluation.'}], 'secondaryOutcomes': [{'measure': 'Baseline blood pressure (BP).', 'timeFrame': '20 minutes before ketamine infusion.', 'description': 'Baseline BP will be measured during the physical examination 20 minutes before ketamine infusion.'}, {'measure': 'Changes from baseline in blood pressure (BP)', 'timeFrame': 'every 5 minutes in a 300 minutes period', 'description': 'BP will be monitored continuously for a 4-hour period. BP assessments will be taken every five minutes for the period mentioned. The assessment will start 20 minutes before ketamine administration and will finish 4hrs after starting.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ketamine', 'Depression', 'Depressive Disorder'], 'conditions': ['Depressive Disorder,', 'Treatment-Resistant Depression']}, 'descriptionModule': {'briefSummary': 'A randomized multicentric parallel arms study involving the use of ketamine for treatment-resistant depression will be held at three national health provider clinics in the Mexican population. The purpose of this study is to determine whether clinical response seen in previous studies is replicable in this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-65 years old\n* Mayor Depressive Disorder Diagnosis based on DSM-IV TR.\n* Classification of MDD as treatment-resistant.\n* No brain structural abnormalities as evidenced by an MRI scan.\n* Signed acceptance of Informed Consent.\n\nExclusion Criteria:\n\n* Other psychiatric diagnosis apart from MDD.\n* Substance abuse or dependence (prior or during study).\n* Pregnancy.\n* Congestive heart disease.\n* Personal history of psychosis.\n* First-degree relative with history of psychosis.\n* Glaucoma.\n* Present neurological disease.\n* High blood or pulmonary artery pressure.\n* Declining the signing of the informed consent.'}, 'identificationModule': {'nctId': 'NCT01868802', 'briefTitle': 'Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population', 'organization': {'class': 'OTHER', 'fullName': 'American British Cowdray Medical Center'}, 'officialTitle': 'Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population', 'orgStudyIdInfo': {'id': 'ABC KET-DRT-01-2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketamine treated', 'interventionNames': ['Drug: Ketamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control, placebo treated', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'otherNames': ['Ketalar'], 'description': 'A single dose of 0.5mg/kg intravenous ketamine infusion will be administered over 40 minutes.', 'armGroupLabels': ['Ketamine treated']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Saline at 0.9% intravenous infusion will be administered over 40 minutes.', 'armGroupLabels': ['Control, placebo treated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05300', 'city': 'Mexico City', 'state': 'Mexico City', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Eduardo San Esteban, M.D.', 'role': 'CONTACT', 'email': 'esanesteban@hotmail.com', 'phone': '+52 (55) 52308000'}, {'name': 'Paul J Lamothe Molina, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ABC Neurological Center', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'centralContacts': [{'name': 'Paul J Lamothe, M.D.', 'role': 'CONTACT', 'email': 'paul@lamothe.com', 'phone': '+52 (55) 11031750'}, {'name': 'David N Lopez-Garza, M.D.', 'role': 'CONTACT', 'email': 'davidlopezgarza@prodigy.net.mx', 'phone': '+ 52 (55) 11031750'}], 'overallOfficials': [{'name': 'Paul J Lamothe, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'American British Cowdray Medical Center'}, {'name': 'David N Lopez-Garza, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'American British Cowdray Medical Center'}, {'name': 'Manuel Ruiz-Alvarez, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'American British Cowdray Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paul J. Lamothe', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief of the Research Department, Neurological Center.', 'investigatorFullName': 'Paul J. Lamothe', 'investigatorAffiliation': 'American British Cowdray Medical Center'}}}}