Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2026-02-26 @ 6:53 AM
Study NCT ID:
NCT02610712
Status:
UNKNOWN
Last Update Posted:
2016-09-21
First Post:
2015-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of the Use of Ketamine in Treatment Resistant Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-01-31', 'releaseDate': '2018-08-29'}], 'estimatedResultsFirstSubmitDate': '2018-08-29'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D061218', 'term': 'Depressive Disorder, Treatment-Resistant'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'lastUpdateSubmitDate': '2016-09-20', 'studyFirstSubmitDate': '2015-11-17', 'studyFirstSubmitQcDate': '2015-11-19', 'lastUpdatePostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton Depression Rating Scale (HDRS) Score', 'timeFrame': 'Change from baseline HDRS Score at 24 hours'}], 'secondaryOutcomes': [{'measure': 'Glutamate concentrations in the pregenual cingulate cortex (pgACC)', 'timeFrame': 'Change from baseline Glutamate concentrations in the pgACC at 24 hours', 'description': 'Glutamate concentrations in the pregenual cingulate cortex measured by Magnetic Resonance Spectroscopy'}, {'measure': 'Interleukin-1 (IL-1) and Tumoral Necrosis Factor-alpha (TNF-alpha) serum concentrations', 'timeFrame': 'Change from baseline IL-1 and TNF-alpha serum concentrations from baseline at 24 hours', 'description': 'Interleukin-1 and Tumoral Necrosis Factor-alpha concentrations in serum measured by ELISA'}]}, 'conditionsModule': {'keywords': ['ketamine', 'treatment-resistant', 'depression', 'spectroscopy', 'neuroinflammation'], 'conditions': ['Depressive Disorder, Treatment-Resistant']}, 'referencesModule': {'references': [{'pmid': '10686270', 'type': 'BACKGROUND', 'citation': 'Berman RM, Cappiello A, Anand A, Oren DA, Heninger GR, Charney DS, Krystal JH. Antidepressant effects of ketamine in depressed patients. Biol Psychiatry. 2000 Feb 15;47(4):351-4. doi: 10.1016/s0006-3223(99)00230-9.'}, {'pmid': '20673547', 'type': 'BACKGROUND', 'citation': 'DiazGranados N, Ibrahim LA, Brutsche NE, Ameli R, Henter ID, Luckenbaugh DA, Machado-Vieira R, Zarate CA Jr. Rapid resolution of suicidal ideation after a single infusion of an N-methyl-D-aspartate antagonist in patients with treatment-resistant major depressive disorder. J Clin Psychiatry. 2010 Dec;71(12):1605-11. doi: 10.4088/JCP.09m05327blu. Epub 2010 Jul 13.'}, {'pmid': '21232924', 'type': 'BACKGROUND', 'citation': 'Valentine GW, Mason GF, Gomez R, Fasula M, Watzl J, Pittman B, Krystal JH, Sanacora G. The antidepressant effect of ketamine is not associated with changes in occipital amino acid neurotransmitter content as measured by [(1)H]-MRS. Psychiatry Res. 2011 Feb 28;191(2):122-7. doi: 10.1016/j.pscychresns.2010.10.009. Epub 2011 Jan 12.'}, {'pmid': '22297150', 'type': 'BACKGROUND', 'citation': "Zarate CA Jr, Brutsche NE, Ibrahim L, Franco-Chaves J, Diazgranados N, Cravchik A, Selter J, Marquardt CA, Liberty V, Luckenbaugh DA. Replication of ketamine's antidepressant efficacy in bipolar depression: a randomized controlled add-on trial. Biol Psychiatry. 2012 Jun 1;71(11):939-46. doi: 10.1016/j.biopsych.2011.12.010. Epub 2012 Jan 31."}, {'pmid': '16894061', 'type': 'BACKGROUND', 'citation': 'Zarate CA Jr, Singh JB, Carlson PJ, Brutsche NE, Ameli R, Luckenbaugh DA, Charney DS, Manji HK. A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression. Arch Gen Psychiatry. 2006 Aug;63(8):856-64. doi: 10.1001/archpsyc.63.8.856.'}, {'pmid': '20679587', 'type': 'BACKGROUND', 'citation': 'Diazgranados N, Ibrahim L, Brutsche NE, Newberg A, Kronstein P, Khalife S, Kammerer WA, Quezado Z, Luckenbaugh DA, Salvadore G, Machado-Vieira R, Manji HK, Zarate CA Jr. A randomized add-on trial of an N-methyl-D-aspartate antagonist in treatment-resistant bipolar depression. Arch Gen Psychiatry. 2010 Aug;67(8):793-802. doi: 10.1001/archgenpsychiatry.2010.90.'}, {'pmid': '20700385', 'type': 'BACKGROUND', 'citation': 'Horn DI, Yu C, Steiner J, Buchmann J, Kaufmann J, Osoba A, Eckert U, Zierhut KC, Schiltz K, He H, Biswal B, Bogerts B, Walter M. Glutamatergic and resting-state functional connectivity correlates of severity in major depression - the role of pregenual anterior cingulate cortex and anterior insula. Front Syst Neurosci. 2010 Jul 15;4:33. doi: 10.3389/fnsys.2010.00033. eCollection 2010.'}, {'pmid': '23982301', 'type': 'BACKGROUND', 'citation': 'Murrough JW, Iosifescu DV, Chang LC, Al Jurdi RK, Green CE, Perez AM, Iqbal S, Pillemer S, Foulkes A, Shah A, Charney DS, Mathew SJ. Antidepressant efficacy of ketamine in treatment-resistant major depression: a two-site randomized controlled trial. Am J Psychiatry. 2013 Oct;170(10):1134-42. doi: 10.1176/appi.ajp.2013.13030392.'}, {'pmid': '23273725', 'type': 'BACKGROUND', 'citation': 'Musazzi L, Treccani G, Mallei A, Popoli M. The action of antidepressants on the glutamate system: regulation of glutamate release and glutamate receptors. Biol Psychiatry. 2013 Jun 15;73(12):1180-8. doi: 10.1016/j.biopsych.2012.11.009. Epub 2012 Dec 28.'}, {'pmid': '21672551', 'type': 'BACKGROUND', 'citation': 'Luykx JJ, Laban KG, van den Heuvel MP, Boks MP, Mandl RC, Kahn RS, Bakker SC. Region and state specific glutamate downregulation in major depressive disorder: a meta-analysis of (1)H-MRS findings. Neurosci Biobehav Rev. 2012 Jan;36(1):198-205. doi: 10.1016/j.neubiorev.2011.05.014. Epub 2011 Jun 6.'}, {'pmid': '22212598', 'type': 'BACKGROUND', 'citation': 'Stone JM, Dietrich C, Edden R, Mehta MA, De Simoni S, Reed LJ, Krystal JH, Nutt D, Barker GJ. Ketamine effects on brain GABA and glutamate levels with 1H-MRS: relationship to ketamine-induced psychopathology. Mol Psychiatry. 2012 Jul;17(7):664-5. doi: 10.1038/mp.2011.171. Epub 2012 Jan 3. No abstract available.'}, {'pmid': '19150053', 'type': 'BACKGROUND', 'citation': 'Miller AH, Maletic V, Raison CL. Inflammation and its discontents: the role of cytokines in the pathophysiology of major depression. Biol Psychiatry. 2009 May 1;65(9):732-41. doi: 10.1016/j.biopsych.2008.11.029. Epub 2009 Jan 15.'}, {'pmid': '20015486', 'type': 'BACKGROUND', 'citation': 'Dowlati Y, Herrmann N, Swardfager W, Liu H, Sham L, Reim EK, Lanctot KL. A meta-analysis of cytokines in major depression. Biol Psychiatry. 2010 Mar 1;67(5):446-57. doi: 10.1016/j.biopsych.2009.09.033. Epub 2009 Dec 16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy of the use of intravenous low-dose ketamine in the treatment of treatment-resistant depression (TRD), as well as the changes in Glutamate neurotransmission and inflammatory serum markers.', 'detailedDescription': 'The purpose of this study is to determine the efficacy of the use of intravenous low-dose ketamine (0.5 mg/kg) in the treatment of treatment-resistant depression (TRD), as well as the changes in Glutamate neurotransmission measured by Magnetic Resonance Imaging Spectroscopy and inflammatory serum markers (IL-6, TNF-alpha).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treatment-Resistant Depression (Failure to respond to two or more trials of antidepressant monotherapy or failure to respond to four or more trials of different antidepressant therapies)\n* Acceptance of participation via the informed consent\n\nExclusion Criteria:\n\n* Psychiatric comorbidity (except anxiety related disorders)\n* Substance abuse or dependence in the previous 3 months\n* Evidence of structural abnormalities in brain imaging\n* Pregnancy\n* Previous hypersensitivity to ketamine\n* Heart failure or insufficiency\n* Familial or personal history of psychosis\n* Glaucoma\n* Major neurological disease\n* Uncontrolled systemic arterial hypertension\n* MRI contraindications\n* Non-acceptance of participation via informed consent'}, 'identificationModule': {'nctId': 'NCT02610712', 'briefTitle': 'Clinical Trial of the Use of Ketamine in Treatment Resistant Depression', 'organization': {'class': 'OTHER', 'fullName': 'National Institute of Neurology and Neurosurgery, Mexico'}, 'officialTitle': 'Clinical Trial of the Use of Ketamine in Treatment Resistant Depression', 'orgStudyIdInfo': {'id': '63/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TRD patients', 'description': 'Treatment-Resistant (TRD) patients to receive intravenous ketamine at 0.5 mg/kg dose.', 'interventionNames': ['Drug: Ketamine']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'armGroupLabels': ['TRD patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14269', 'city': 'Mexico City', 'state': 'Mexico City', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Rodrigo Pérez-Esparza, MD', 'role': 'CONTACT', 'email': 'dr.rodrigope@gmail.com', 'phone': '56063822', 'phoneExt': '1034'}, {'name': 'Jesús Ramírez-Bermúdez, MD, MSc', 'role': 'CONTACT', 'email': 'jesusramirezb@yahoo.com.mx', 'phone': '56063822', 'phoneExt': '1034'}], 'facility': 'National Institute of Neurology and Neurosurgery', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'centralContacts': [{'name': 'Rodrigo Pérez-Esparza, MD', 'role': 'CONTACT', 'email': 'dr.rodrigope@gmail.com', 'phone': '56063822', 'phoneExt': '1034'}, {'name': 'Jesús Ramírez-Bermúdez, MD, MSc', 'role': 'CONTACT', 'email': 'jesusramirezb@yahoo.com.mx', 'phone': '56063822', 'phoneExt': '1034'}], 'overallOfficials': [{'name': 'Rodrigo Pérez-Esparza, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Neurology and Neurosurgery, Mexico'}, {'name': 'Jesús Ramírez-Bermúdez, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Neurology and Neurosurgery, Mexico'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Neurology and Neurosurgery, Mexico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fourth-year Psychiatry Resident', 'investigatorFullName': 'Rodrigo Pérez Esparza', 'investigatorAffiliation': 'National Institute of Neurology and Neurosurgery, Mexico'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-08-29', 'type': 'RELEASE'}, {'date': '2019-01-31', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Rodrigo Pérez Esparza, Fourth-year Psychiatry Resident, National Institute of Neurology and Neurosurgery, Mexico'}}}}