Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 10:22 PM
Study NCT ID:
NCT02062658
Status:
COMPLETED
Last Update Posted:
2016-12-29
First Post:
2014-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Extending Ketamine's Effects in OCD With Exposure and Response Prevention (EX/RP)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety 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': 'carolynrodriguez@stanford.edu', 'phone': '6507236158', 'title': 'Dr. Carolyn Rodriguez, Assistant Professor', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Ketamine, Exposure & Response Prevention', 'description': '0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)\n\nKetamine: 0.5mg/kg IV\n\nExposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention.', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketamine, Exposure & Response Prevention', 'description': '0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)\n\nKetamine: 0.5mg/kg IV\n\nExposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks', 'description': 'Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ketamine, Exposure & Response Prevention', 'description': '0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)\n\nKetamine: 0.5mg/kg IV\n\nExposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Adult outpatients were recruited from the community starting March 2014 until March 2015.', 'preAssignmentDetails': 'No pre-assignment was done.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ketamine, Exposure & Response Prevention', 'description': '0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)\n\nKetamine: 0.5mg/kg IV\n\nExposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.3', 'spread': '10.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-08', 'studyFirstSubmitDate': '2014-02-12', 'resultsFirstSubmitDate': '2016-05-19', 'studyFirstSubmitQcDate': '2014-02-12', 'lastUpdatePostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-09-06', 'studyFirstPostDateStruct': {'date': '2014-02-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale', 'timeFrame': '2 weeks', 'description': 'Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['OCD'], 'conditions': ['Obsessive-Compulsive Disorder']}, 'referencesModule': {'references': [{'pmid': '27046314', 'type': 'RESULT', 'citation': 'Rodriguez CI, Wheaton M, Zwerling J, Steinman SA, Sonnenfeld D, Galfalvy H, Simpson HB. Can exposure-based CBT extend the effects of intravenous ketamine in obsessive-compulsive disorder? an open-label trial. J Clin Psychiatry. 2016 Mar;77(3):408-9. doi: 10.4088/JCP.15l10138. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates if a single dose of IV Ketamine can rapidly improve Obsessive-Compulsive Disorder (OCD) symptoms and whether these effect can be maintained with a condensed course of a type of Cognitive Behavioral Therapy called Exposure and Response Prevention (EX/RP). You will be compensated for your time and travel. Participants must be between the ages of 18-55.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-55\n* Physically healthy and not currently pregnant\n* Primary Diagnosis of OCD\n* Sufficient severity of symptoms\n* Currently off all psychotropic medication OR\n* Currently on adequate dose of medication for treatment of OCD, but have not achieved at least partial remission\n* Able to provide consent\n\nExclusion Criteria:\n\n* Psychiatric conditions that make participation unsafe (schizophrenia \\[either self or first degree relative e.g. siblings, parents\\], history of violence, severe depression, eating disorder, substance dependence \\[including nicotine\\])\n* Female patients who are either pregnant or nursing\n* Planning to commence EX/RP during the period of the study or those who have completed an adequate dose of EX/RP (defined as 8 or more sessions within 2 months) within 8 weeks prior to enrollment.\n\nperiod of the study\n\n* Allergy to ketamine\n* Participants for whom being off of medication is not clinically recommended\n* Medical conditions that make participation unsafe (e.g. high blood pressure, head injury)\n* Currently on medications that make participation unsafe'}, 'identificationModule': {'nctId': 'NCT02062658', 'briefTitle': "Extending Ketamine's Effects in OCD With Exposure and Response Prevention (EX/RP)", 'organization': {'class': 'OTHER', 'fullName': 'New York State Psychiatric Institute'}, 'officialTitle': "Extending Ketamine's Effects in Obsessive-Compulsive Disorder (OCD) With Exposure and Response Prevention (EX/RP)", 'orgStudyIdInfo': {'id': '#6811'}, 'secondaryIdInfos': [{'id': 'K23MH092434', 'link': 'https://reporter.nih.gov/quickSearch/K23MH092434', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketamine, Exposure & Response Prevention', 'description': '0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)', 'interventionNames': ['Drug: Ketamine', 'Behavioral: Exposure and Response Prevention']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'otherNames': ['Ketamine hydrochloride'], 'description': '0.5mg/kg IV', 'armGroupLabels': ['Ketamine, Exposure & Response Prevention']}, {'name': 'Exposure and Response Prevention', 'type': 'BEHAVIORAL', 'otherNames': ['EX/RP'], 'description': 'A type of Cognitive Behavioral Therapy called Exposure and Response Prevention.', 'armGroupLabels': ['Ketamine, Exposure & Response Prevention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York State Psychiatric Insitute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'H Blair Simpson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia-NYSPI-RFMH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York State Psychiatric Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}