Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-01-25 @ 1:34 AM
Study NCT ID:
NCT03666494
Status:
UNKNOWN
Last Update Posted:
2018-09-13
First Post:
2018-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketamine Co-induction for Patients With Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D015742', 'term': 'Propofol'}, {'id': 'D005283', 'term': 'Fentanyl'}], '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': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-12', 'studyFirstSubmitDate': '2018-08-15', 'studyFirstSubmitQcDate': '2018-09-07', 'lastUpdatePostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression Severity', 'timeFrame': 'At time of discharge from post-anesthetic care unit, until 3 hours post operatvie', 'description': 'Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and \\>34 is severe depression.'}, {'measure': 'Depression Severity', 'timeFrame': '72 hours post-operative', 'description': 'Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and \\>34 is severe depression.'}, {'measure': 'Depression Severity', 'timeFrame': '7-days post-operative', 'description': 'Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and \\>34 is severe depression.'}, {'measure': 'Depression Severity', 'timeFrame': '30-days post-operative', 'description': 'Severity of depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS), 0-60 where 0 to 6 is normal, 7-19 is mild depression, 20-34 is moderate depression, and \\>34 is severe depression.'}], 'secondaryOutcomes': [{'measure': 'Pain Score', 'timeFrame': 'Pre-operatively', 'description': 'Verbally reported numeric pain score (out of 10)'}, {'measure': 'Pain Score', 'timeFrame': 'Upon discharge from PACU, up to 3 hours postoperative', 'description': 'Verbally reported numeric pain score (out of 10)'}, {'measure': 'Pain Score', 'timeFrame': '72 hours post-opertaive', 'description': 'Verbally reported numeric pain score (out of 10)'}, {'measure': 'Pain Score', 'timeFrame': '7-days post-op', 'description': 'Verbally reported numeric pain score (out of 10)'}, {'measure': 'Pain Score', 'timeFrame': '30-days post-op', 'description': 'Verbally reported numeric pain score (out of 10)'}, {'measure': 'Analgesia use', 'timeFrame': 'Pre-operatively', 'description': 'Morphine equivalents (in milligrams)'}, {'measure': 'Analgesia use', 'timeFrame': 'Upon discharge from PACU, up to 3 hours postoperative', 'description': 'Morphine equivalents (in milligrams)'}, {'measure': 'Analgesia use', 'timeFrame': '72 hours post-operative', 'description': 'Morphine equivalents (in milligrams)'}, {'measure': 'Analgesia use', 'timeFrame': '7-days post-operative', 'description': 'Morphine equivalents (in milligrams)'}, {'measure': 'Analgesia use', 'timeFrame': '30-days post-operative', 'description': 'Morphine equivalents (in milligrams)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ketamine', 'Depression', 'Anesthesia']}, 'referencesModule': {'references': [{'pmid': '12088953', 'type': 'BACKGROUND', 'citation': 'Kudoh A, Takahira Y, Katagai H, Takazawa T. Small-dose ketamine improves the postoperative state of depressed patients. Anesth Analg. 2002 Jul;95(1):114-8, table of contents. doi: 10.1097/00000539-200207000-00020.'}, {'pmid': '25010396', 'type': 'BACKGROUND', 'citation': 'McGirr A, Berlim MT, Bond DJ, Fleck MP, Yatham LN, Lam RW. A systematic review and meta-analysis of randomized, double-blind, placebo-controlled trials of ketamine in the rapid treatment of major depressive episodes. Psychol Med. 2015 Mar;45(4):693-704. doi: 10.1017/S0033291714001603. Epub 2014 Jul 10.'}, {'pmid': '25698228', 'type': 'BACKGROUND', 'citation': 'Lee EE, Della Selva MP, Liu A, Himelhoch S. Ketamine as a novel treatment for major depressive disorder and bipolar depression: a systematic review and quantitative meta-analysis. Gen Hosp Psychiatry. 2015 Mar-Apr;37(2):178-84. doi: 10.1016/j.genhosppsych.2015.01.003. Epub 2015 Jan 15.'}, {'pmid': '25038867', 'type': 'BACKGROUND', 'citation': 'Fond G, Loundou A, Rabu C, Macgregor A, Lancon C, Brittner M, Micoulaud-Franchi JA, Richieri R, Courtet P, Abbar M, Roger M, Leboyer M, Boyer L. Ketamine administration in depressive disorders: a systematic review and meta-analysis. Psychopharmacology (Berl). 2014 Sep;231(18):3663-76. doi: 10.1007/s00213-014-3664-5. Epub 2014 Jul 20.'}, {'pmid': '21557878', 'type': 'BACKGROUND', 'citation': 'Larkin GL, Beautrais AL. A preliminary naturalistic study of low-dose ketamine for depression and suicide ideation in the emergency department. Int J Neuropsychopharmacol. 2011 Sep;14(8):1127-31. doi: 10.1017/S1461145711000629. Epub 2011 May 5.', 'retractions': [{'pmid': '28637184', 'source': 'Int J Neuropsychopharmacol. 2017 Jul 1;20(7):611'}]}, {'pmid': '24688759', 'type': 'BACKGROUND', 'citation': 'Caddy C, Giaroli G, White TP, Shergill SS, Tracy DK. Ketamine as the prototype glutamatergic antidepressant: pharmacodynamic actions, and a systematic review and meta-analysis of efficacy. Ther Adv Psychopharmacol. 2014 Apr;4(2):75-99. doi: 10.1177/2045125313507739.'}, {'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.'}]}, 'descriptionModule': {'briefSummary': 'Ketamine hydrochloride, an anesthetic medication, has been demonstrated to acutely and rapidly improve depressive symptoms but not yet been adequately studied for this effect when used as part of a general anesthetic for surgery. This proposed single-centre, double-blinded, randomized clinical trial of adult patients with depression presenting for gynecologic surgery would compare severity of depressive symptoms between patients receiving and not receiving ketamine as part of their general anesthetic.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of major depressive disorder\n* Presentation for gynecologic surgery requiring a general anesthetic\n\nExclusion Criteria:\n\n* Marked co-morbid cardiovascular disease\n* Marked co-morbid respiratory disease\n* History of intracranial hypertension\n* History of seizures\n* ASA Physical Status Classification IV or greater\n* History of psychosis\n* Current pregnancy\n* Contraindication to ketamine administration'}, 'identificationModule': {'nctId': 'NCT03666494', 'briefTitle': 'Ketamine Co-induction for Patients With Major Depressive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Saskatchewan'}, 'officialTitle': 'Ketamine Co-induction for Patients With Major Depressive Disorder; a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Bio 18-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Arm', 'description': "As part of the patient's anesthetic induction, they will receive propofol and fentanyl.", 'interventionNames': ['Drug: Propofol', 'Drug: Fentanyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketamine Arm', 'description': "As part of the patient's anesthetic induction, they will receive propofol, fentanyl, as well as ketamine hydrochloride.", 'interventionNames': ['Drug: Ketamine Hydrochloride', 'Drug: Propofol', 'Drug: Fentanyl']}], 'interventions': [{'name': 'Ketamine Hydrochloride', 'type': 'DRUG', 'description': 'As part of anesthetic induction, the addition of ketamine hydrochloride 0.5mg/kg.', 'armGroupLabels': ['Ketamine Arm']}, {'name': 'Propofol', 'type': 'DRUG', 'description': "As part of the patient's anesthetic induction, they will receive propofol.", 'armGroupLabels': ['Control Arm', 'Ketamine Arm']}, {'name': 'Fentanyl', 'type': 'DRUG', 'description': "As part of the patient's anesthetic induction, they will receive fentanyl.", 'armGroupLabels': ['Control Arm', 'Ketamine Arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jonathan Gamble, MD', 'role': 'CONTACT', 'email': 'j_gamble@yahoo.com', 'phone': '306-655-1183'}, {'name': 'Jordon Steeg, MD', 'role': 'CONTACT', 'email': 'jordon.steeg@usask.ca', 'phone': '306-222-9782'}], 'overallOfficials': [{'name': 'Jonathan Gamble, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Saskatchewan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Saskatchewan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}