Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-26 @ 12:52 AM
Study NCT ID:
NCT03511534
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-16
First Post:
2018-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Open/Aftercare Treatment for Participants Diagnosed With Obsessive Compulsive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Participants will choose to enter the psychotherapy or pharmacotherapy arm.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2018-04-18', 'studyFirstSubmitQcDate': '2018-04-18', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)', 'timeFrame': 'Up to 14 weeks', 'description': 'Improvement in OCD severity is measured by the 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 is defined as at least a 35% reduction on the YBOCS.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['treatment, psychotherapy, pharmacotherapy'], 'conditions': ['OCD']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to provide participants diagnosed with obsessive compulsive disorder (OCD) and completed one of the active study protocols at the Rodriguez Lab, with open/aftercare treatment.', 'detailedDescription': 'After completing one of the active clinical studies participants have the option to enroll in this protocol that offers open treatment.\n\nThe goal is to compare two forms of current standard treatments, psychotherapy vs pharmacotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Ability to speak and understand English\n2. Capacity to consent (e.g. as determined by assessing the patient's understanding of the risks, benefits, and procedures of the study)\n3. Completed an active study protocol at the Rodriguez Lab at Stanford University\n\nExclusion Criteria:\n\n1. Children younger than 18\n2. Active suicidality"}, 'identificationModule': {'nctId': 'NCT03511534', 'briefTitle': 'Open/Aftercare Treatment for Participants Diagnosed With Obsessive Compulsive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Open/Aftercare Treatment for Participants Diagnosed With Obsessive Compulsive Disorder', 'orgStudyIdInfo': {'id': '41165'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Psychotherapy', 'description': 'Participants will receive evidenced based psychotherapy by a trained psychologist', 'interventionNames': ['Behavioral: Psychotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pharmacotherapy', 'description': 'Participants will receive pharmacotherapy by a psychiatrist', 'interventionNames': ['Other: Pharmacotherapy']}], 'interventions': [{'name': 'Psychotherapy', 'type': 'BEHAVIORAL', 'description': 'Evidenced based psychotherapy by a trained psychologist', 'armGroupLabels': ['Psychotherapy']}, {'name': 'Pharmacotherapy', 'type': 'OTHER', 'description': 'Pharmacotherapy by a psychiatrist', 'armGroupLabels': ['Pharmacotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Carolyn Rodriguez, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor, Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Carolyn Rodriguez', 'investigatorAffiliation': 'Stanford University'}}}}