Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-02-25 @ 8:27 PM
Study NCT ID:
NCT02305394
Status:
UNKNOWN
Last Update Posted:
2014-12-02
First Post:
2014-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Subanesthetic Dose of Ketamine Combined With Propofol on Cognitive Function in Depressive Patients Undergoing Electroconvulsive Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D003072', 'term': 'Cognition Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077330', 'term': 'Saline Solution'}], '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'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-01', 'studyFirstSubmitDate': '2014-11-19', 'studyFirstSubmitQcDate': '2014-12-01', 'lastUpdatePostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mini-Mental State examination score', 'timeFrame': 'at 24 hours after the sixth ECT', 'description': 'Mini-Mental State examination score will be measured at 24 hours after the sixth ECT.'}], 'secondaryOutcomes': [{'measure': 'Mini-Mental State examination score', 'timeFrame': 'at 24 hours before the first ECT and 24 hours after each ECT, except the sixth ECT.', 'description': 'Mini-Mental State examination score will be measured at 24 hours before the first ECT and 24 hours after each ECT, except the sixth ECT.'}, {'measure': 'Effects on Antidepression (Hamilton Depression Rating Scale(HDRS)', 'timeFrame': 'at 24 hours before the first ECT and 24 hours after each ECT', 'description': 'Effect on antidepression will be measured by 24-item Hamilton Depression Rating Scale(HDRS)'}, {'measure': 'Seizure Duration and Seizure Energy Index', 'timeFrame': 'at 30 seconds after each ECT', 'description': 'Seizure duration and Seizure energy index will be recorded by the ECT apparatus.'}, {'measure': 'Brief Psychiatric Rating Scale（BPRS）', 'timeFrame': '60 minutes prior to the first ECT and at 40, 80, 110, and 230 minutes after each ECT', 'description': 'Brief Psychiatric Rating Scale is related to psychotomimetic side-effect.'}, {'measure': 'Adverse Effects include nausea, vomit, headache, tachycardia and increased blood pressure.', 'timeFrame': 'at 40 minutes after each ECT', 'description': 'Adverse effects include nausea, vomit, headache, tachycardia and increased blood pressure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ketamine', 'Electroconvulsive Therapy', 'Cognitive Function'], 'conditions': ['Depressive Symptoms', 'Impaired Cognition', 'Electroconvulsive Therapy']}, 'referencesModule': {'references': [{'pmid': '19397926', 'type': 'BACKGROUND', 'citation': 'Machado-Vieira R, Salvadore G, Diazgranados N, Zarate CA Jr. Ketamine and the next generation of antidepressants with a rapid onset of action. Pharmacol Ther. 2009 Aug;123(2):143-50. doi: 10.1016/j.pharmthera.2009.02.010. Epub 2009 May 3.'}, {'pmid': '17884272', 'type': 'BACKGROUND', 'citation': 'Garcia LS, Comim CM, Valvassori SS, Reus GZ, Barbosa LM, Andreazza AC, Stertz L, Fries GR, Gavioli EC, Kapczinski F, Quevedo J. Acute administration of ketamine induces antidepressant-like effects in the forced swimming test and increases BDNF levels in the rat hippocampus. Prog Neuropsychopharmacol Biol Psychiatry. 2008 Jan 1;32(1):140-4. doi: 10.1016/j.pnpbp.2007.07.027. Epub 2007 Aug 8.'}, {'pmid': '16429123', 'type': 'BACKGROUND', 'citation': 'Berton O, Nestler EJ. New approaches to antidepressant drug discovery: beyond monoamines. Nat Rev Neurosci. 2006 Feb;7(2):137-51. doi: 10.1038/nrn1846.'}, {'pmid': '18379337', 'type': 'BACKGROUND', 'citation': 'Pigot M, Andrade C, Loo C. Pharmacological attenuation of electroconvulsive therapy--induced cognitive deficits: theoretical background and clinical findings. J ECT. 2008 Mar;24(1):57-67. doi: 10.1097/YCT.0b013e3181616c14.'}, {'pmid': '19897179', 'type': 'BACKGROUND', 'citation': 'aan het Rot M, Collins KA, Murrough JW, Perez AM, Reich DL, Charney DS, Mathew SJ. Safety and efficacy of repeated-dose intravenous ketamine for treatment-resistant depression. Biol Psychiatry. 2010 Jan 15;67(2):139-45. doi: 10.1016/j.biopsych.2009.08.038.'}, {'pmid': '24831997', 'type': 'BACKGROUND', 'citation': 'Chen J, Peng LH, Luo J, Liu L, Lv F, Li P, Ao L, Hao XC, Min S. Effects of low-dose ketamine combined with propofol on phosphorylation of AMPA receptor GluR1 subunit and GABAA receptor in hippocampus of stressed rats receiving electroconvulsive shock. J ECT. 2015 Mar;31(1):50-6. doi: 10.1097/YCT.0000000000000148.'}, {'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': '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': '19545857', 'type': 'BACKGROUND', 'citation': 'Price RB, Nock MK, Charney DS, Mathew SJ. Effects of intravenous ketamine on explicit and implicit measures of suicidality in treatment-resistant depression. Biol Psychiatry. 2009 Sep 1;66(5):522-6. doi: 10.1016/j.biopsych.2009.04.029. Epub 2009 Jul 9.'}, {'pmid': '21466832', 'type': 'BACKGROUND', 'citation': 'Ibrahim L, Diazgranados N, Luckenbaugh DA, Machado-Vieira R, Baumann J, Mallinger AG, Zarate CA Jr. Rapid decrease in depressive symptoms with an N-methyl-d-aspartate antagonist in ECT-resistant major depression. Prog Neuropsychopharmacol Biol Psychiatry. 2011 Jun 1;35(4):1155-9. doi: 10.1016/j.pnpbp.2011.03.019. Epub 2011 Apr 3.'}, {'pmid': '16801824', 'type': 'BACKGROUND', 'citation': 'McDaniel WW, Sahota AK, Vyas BV, Laguerta N, Hategan L, Oswald J. Ketamine appears associated with better word recall than etomidate after a course of 6 electroconvulsive therapies. J ECT. 2006 Jun;22(2):103-6. doi: 10.1097/00124509-200606000-00005.'}, {'pmid': '12556568', 'type': 'BACKGROUND', 'citation': 'Krystal AD, Weiner RD, Dean MD, Lindahl VH, Tramontozzi LA 3rd, Falcone G, Coffey CE. Comparison of seizure duration, ictal EEG, and cognitive effects of ketamine and methohexital anesthesia with ECT. J Neuropsychiatry Clin Neurosci. 2003 Winter;15(1):27-34. doi: 10.1176/jnp.15.1.27.'}, {'pmid': '21400226', 'type': 'BACKGROUND', 'citation': 'Kranaster L, Kammerer-Ciernioch J, Hoyer C, Sartorius A. Clinically favourable effects of ketamine as an anaesthetic for electroconvulsive therapy: a retrospective study. Eur Arch Psychiatry Clin Neurosci. 2011 Dec;261(8):575-82. doi: 10.1007/s00406-011-0205-7. Epub 2011 Mar 13.'}, {'pmid': '22622291', 'type': 'BACKGROUND', 'citation': 'Wang X, Chen Y, Zhou X, Liu F, Zhang T, Zhang C. Effects of propofol and ketamine as combined anesthesia for electroconvulsive therapy in patients with depressive disorder. J ECT. 2012 Jun;28(2):128-32. doi: 10.1097/YCT.0b013e31824d1d02.'}, {'pmid': '23703230', 'type': 'BACKGROUND', 'citation': 'Kellner CH, Briggs MC, Pasculli RM, Bryson EO. Antidepressant effect of the first electroconvulsive therapy with ketamine and/or propofol. J ECT. 2013 Jun;29(2):149. doi: 10.1097/YCT.0b013e3182702980. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Electroconvulsive therapy (ECT) is an effective treatment for depression compared with the current antidepressant agents，but the most important side effect is cognitive dysfunction. The purpose of this study is to determine whether subanesthetic dose of ketamine combined with propofol is superior to propofol anesthesia alone in improving cognitive function in depressive patients undergoing ECT.', 'detailedDescription': 'Depression is one of the most debilitating and widespread illnesses affecting up to 20% of individuals in their lifetime. However, the current antidepressant agents take weeks to work, and fail to help at least 40% of depressed patients. Electroconvulsive therapy (ECT) is a remarkably effective treatment for depression, but its use is limited by cognitive dysfunction.\n\nAs a result, it is becoming a clinical problem which need to be settled urgently. Previous clinical study showed that subanesthetic dose of ketamine could play a role in antidepressant effects with safety and minimal positive psychotic symptoms.The investigators also found that subanesthetic dose of ketamine combined with other anesthetics could improve cognitive function in depressive rats receiving electroconvulsive shock (a model for analogy with ECT). Few clinical researches concerned the effects of subanesthetic dose of ketamine combined with propofol anesthesia on cognitive function in patients after ECT, therefore the investigators conduct this randomized controlled double-blind trial. In this study, cognitive function will be rated by Mini-Mental State examination score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. diagnosed with moderate or severe depression according to Diagnostic and Statistical Manual of Mental Disorders\n2. aged from 18 to 65 years old\n\nExclusion Criteria:\n\n1. cerebrovascular malformation, arterial aneurysm, hypertension, or glaucoma;\n2. classification of American Society of Anesthesiologists physical status score IV or V;\n3. complications such as respiratory disease, cardiovascular disease, intracranial hypertension, cerebral vascular disorder;\n4. presence of a foreign body such as pacemaker, intracranial electrode, and clips;\n5. history of seizures;\n6. history of drug abuse;\n7. concomitant presence of a mental disorder;\n8. pregnancy;\n9. history of serious adverse effects related to anesthetics;\n10. refusal to consent for the study, or refusal to undergo one single ECT during the first week of therapy.\n11. hyperthyreosis'}, 'identificationModule': {'nctId': 'NCT02305394', 'briefTitle': 'Effect of Subanesthetic Dose of Ketamine Combined With Propofol on Cognitive Function in Depressive Patients Undergoing Electroconvulsive Therapy', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'Effect of Subanesthetic Dose of Ketamine Combined With Propofol on Cognitive Function in Depressive Patients Undergoing Electroconvulsive Therapy ---a Randomized Control Double-Blind Clinical Trial', 'orgStudyIdInfo': {'id': 'CYYYMZ-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PK group (ketamine and propofol)', 'description': 'propofol 1.5 mg/kg and ketamine 0.3 mg/kg will be administered to participants separately by intravenous infusion.When patients become unconscious, succinylcholine 1 mg/kg (a muscle relaxant) will be administered intravenously. After 1 minute of succinylcholine infused, ECT will be performed with bitemporal electrode placement using a stimulus dose of 1.0-millisecond pulse width, 60-Hz frequency, 6.0-second stimulus duration, and 0.8-A maximal stimulus intensity.', 'interventionNames': ['Drug: ketamine and propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'P group (propofol group)', 'description': 'propofol 1.5 mg/kg and normal saline \\[weight(kg)×0.3÷10\\]ml will be administered to participants separately by intravenous infusion.When patients become unconscious, succinylcholine 1 mg/kg (a muscle relaxant) will be administered intravenously. After 1 minute of succinylcholine infused, ECT will be performed with bitemporal electrode placement using a stimulus dose of 1.0-millisecond pulse width, 60-Hz frequency, 6.0-second stimulus duration, and 0.8-A maximal stimulus intensity.', 'interventionNames': ['Drug: propofol and normal saline']}], 'interventions': [{'name': 'ketamine and propofol', 'type': 'DRUG', 'description': 'propofol 1.5 mg/kg and ketamine 0.3 mg/kg will be administered to participants separately by intravenous infusion.', 'armGroupLabels': ['PK group (ketamine and propofol)']}, {'name': 'propofol and normal saline', 'type': 'DRUG', 'description': 'propofol 1.5 mg/kg and normal saline \\[weight(kg)×0.3÷10\\]ml will be administered to participants separately by intravenous infusion.', 'armGroupLabels': ['P group (propofol group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400016', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'contacts': [{'name': 'Su Min, MD', 'role': 'CONTACT', 'email': 'ms89011068@163.com', 'phone': '+86-23-89011068'}], 'facility': 'China,Chongqing The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Qibin Chen, Master', 'role': 'CONTACT', 'email': '403497559@qq.com', 'phone': '023-89011061'}], 'overallOfficials': [{'name': 'Su Min', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Chongqing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Chongqing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'The Department of Anesthesia and Pain Medicine', 'investigatorFullName': 'Min Su', 'investigatorAffiliation': 'First Affiliated Hospital of Chongqing Medical University'}}}}