Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-29 @ 6:22 AM
Study NCT ID:
NCT02422303
Status:
TERMINATED
Last Update Posted:
2018-02-15
First Post:
2015-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Low Dose Ketamine Given at Induction of Anesthesia on Postoperative Mood in Patients With Depressive Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gillis@uthscsa.edu', 'phone': '210-567-4500', 'title': 'Bonnie Gillis', 'organization': 'University of Texas Health Science Center San Antonio'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ketamine Group', 'description': 'This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia.\n\nketamine: Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia.', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No Ketamine Group', 'description': 'This group will not receive ketamine at induction of general anesthesia.', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Depression Score Using Goldberg Depression Screening Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine Group', 'description': 'This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia.\n\nketamine: Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia.'}, {'id': 'OG001', 'title': 'No Ketamine Group', 'description': 'This group will not receive ketamine at induction of general anesthesia.'}], 'timeFrame': 'One week', 'description': 'The Goldberg screening test consists of 18 questions which are answered based upon the previous 10-14 days to assess depression:\n\n0-not at all\n\n1. just a little\n2. somewhat\n3. moderately\n4. quite a lot\n5. very much\n\nThe scores are summed, and the ranges are assessed:\n\n0 - 9 No depression likely 10 - 21 Possible symptoms that may be due to depression or other medical issues.\n\n22 - 35 Mild to Moderate Depression. 36 - 53 Moderate to Severe Depression 54 and up Severely Depressed The higher the score, the more severe you depression is likely to be.', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant data were destroyed at study termination, and no analysis was performed, since no longer available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ketamine Group', 'description': 'This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia.\n\nketamine: Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia.'}, {'id': 'FG001', 'title': 'No Ketamine Group', 'description': 'This group will not receive ketamine at induction of general anesthesia.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ketamine Group', 'description': 'This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia.\n\nketamine: Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia.'}, {'id': 'BG001', 'title': 'No Ketamine Group', 'description': 'This group will not receive ketamine at induction of general anesthesia.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-22', 'studyFirstSubmitDate': '2015-04-16', 'resultsFirstSubmitDate': '2017-12-01', 'studyFirstSubmitQcDate': '2015-04-20', 'lastUpdatePostDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-22', 'studyFirstPostDateStruct': {'date': '2015-04-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression Score Using Goldberg Depression Screening Test', 'timeFrame': 'One week', 'description': 'The Goldberg screening test consists of 18 questions which are answered based upon the previous 10-14 days to assess depression:\n\n0-not at all\n\n1. just a little\n2. somewhat\n3. moderately\n4. quite a lot\n5. very much\n\nThe scores are summed, and the ranges are assessed:\n\n0 - 9 No depression likely 10 - 21 Possible symptoms that may be due to depression or other medical issues.\n\n22 - 35 Mild to Moderate Depression. 36 - 53 Moderate to Severe Depression 54 and up Severely Depressed The higher the score, the more severe you depression is likely to be.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Depression', 'Gynecoligical surgery', 'Ketamine'], 'conditions': ['Depression', 'Major Depressive Disorder']}, 'referencesModule': {'references': [{'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': '24388038', 'type': 'BACKGROUND', 'citation': "Naughton M, Clarke G, O'Leary OF, Cryan JF, Dinan TG. A review of ketamine in affective disorders: current evidence of clinical efficacy, limitations of use and pre-clinical evidence on proposed mechanisms of action. J Affect Disord. 2014 Mar;156:24-35. doi: 10.1016/j.jad.2013.11.014. Epub 2013 Dec 10."}, {'pmid': '23689537', 'type': 'BACKGROUND', 'citation': 'Martinowich K, Jimenez DV, Zarate CA Jr, Manji HK. Rapid antidepressant effects: moving right along. Mol Psychiatry. 2013 Aug;18(8):856-63. doi: 10.1038/mp.2013.55. Epub 2013 May 21.'}]}, 'descriptionModule': {'briefSummary': 'Ketamine has been shown to have an antidepressant effect when given intravenously in doses of 2mg/kg. Ketamine is used as a standard induction drug during general anesthesia. It is known in this instance to decrease postoperative pain. No one has studied whether or not ketamine when given in doses used during general anesthesia (0.5mg/kg intravenous) has an antidepressant effect on surgical patients who suffer from depression. The study is designed to determine whether or not a small dose of ketamine when given at the induction of anesthesia could have an antidepressant effect on surgical patients with depression.', 'detailedDescription': "Non-pregnant females between the ages of 18-65 who are being admitted for gynecological surgery will be given a bedside Goldberg depression screen as part of their routine preanesthetic assessment. If the patient scores five or above on the Goldberg depression screening, they will be asked if they would like to enroll in the study. Exclusion criteria include uncontrolled hypertension, pregnancy, or allergy to ketamine.\n\nOnce the patient is consented they will be randomized to one of two groups. Every patient will receive an antianxiety medication Midazolam and a narcotic fentanyl prior to going to the operating room. Group A will receive ketamine 0.5mg/kg intravenous as part of their induction for general anesthesia. Group B will not receive ketamine as part of their anesthetic. All other induction drugs will be at the discretion of the anesthesiologist performing the anesthetic.\n\nThe patients will be seen by a separate anesthesia provider (who is blinded to the group the patient is in) and the results of the depression screening will be added to the patient's data sheet.\n\nThe patients will be followed again one week after their surgery either in their hospital room (if still hospitalized) or by phone. They will again be given the Goldberg Depression screen and the data will again be added to their data sheet.\n\nSeveral times during the study and at its conclusion the data will be matched with the patients group in order to assess for adverse events such as suicidal ideations, nausea and vomiting. If adverse events are noted, the study design will be altered to take into account the adverse events."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of or current depression scoring five or above on Goldberg Depression Screen\n\nExclusion Criteria:\n\n* Uncontrolled hypertension, allergy to ketamine,pregnancy'}, 'identificationModule': {'nctId': 'NCT02422303', 'briefTitle': 'Effects of Low Dose Ketamine Given at Induction of Anesthesia on Postoperative Mood in Patients With Depressive Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'Effects of Low Dose Ketamine Given at Induction of Anesthesia on Postoperative Mood in Patients With Depressive Symptoms', 'orgStudyIdInfo': {'id': 'HSC20150248H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ketamine Group', 'description': 'This group will receive ketamine 0.5mg/kg IV at induction of general anesthesia.', 'interventionNames': ['Drug: ketamine']}, {'type': 'NO_INTERVENTION', 'label': 'No ketamine group', 'description': 'This group will not receive ketamine at induction of general anesthesia.'}], 'interventions': [{'name': 'ketamine', 'type': 'DRUG', 'otherNames': ['ketalar'], 'description': 'Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia.', 'armGroupLabels': ['Ketamine Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University Hospital', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Bonny C Gillis, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology UTHSCSA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}