Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-04 @ 3:45 AM
Study NCT ID:
NCT02960451
Status:
COMPLETED
Last Update Posted:
2019-05-28
First Post:
2016-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRIME vs Usual Care for Clinical High Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-23', 'studyFirstSubmitDate': '2016-11-07', 'studyFirstSubmitQcDate': '2016-11-08', 'lastUpdatePostDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global Assessment of Functioning', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Service utilization', 'timeFrame': '24 months', 'description': 'hospitalizations and emergency room use'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prodrome', 'cognitive behavioral therapy', 'family focused therapy'], 'conditions': ['Clinical High Risk Syndrome for Psychosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether specialty care is superior to usual care in the treatment of patients at clinical high risk for psychosis.', 'detailedDescription': 'This study is a randomized clinical effectiveness trial for patients at clinical high risk for psychosis that compares two treatments: 1) specialty care delivered in a specialized clinical for patients at clinical high risk for psychosis versus 2) treatment as usual in the community.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must meet all of the following:\n\n 1. Male or female between 12 and 30 years old.\n 2. Understand and sign an informed consent (or assent for minors) document in English.\n 3. Meet diagnostic criteria for prodromal syndrome as per COPS criteria.\n\nExclusion Criteria:\n\n* Subjects must not meet any of the following:\n\n 1. Diagnosis of current or lifetime Axis I psychotic disorder, including mood disorder with psychotic symptoms.\n 2. Impaired intellectual functioning (full-scale IQ\\<70). However, those with an IQ in the 65-69 range will not be excluded if they score \\>75 on the WRAT Reading.\n 3. Past or current history of a clinically significant central nervous system disorder that may contribute to prodromal symptoms or confound their assessment.\n 4. Alcohol or substance dependence in the past 6 months.'}, 'identificationModule': {'nctId': 'NCT02960451', 'briefTitle': 'PRIME vs Usual Care for Clinical High Risk', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Randomized Trial of Usual Care vs. Specialized, Phase-specific Care for Youth at Risk for Psychosis', 'orgStudyIdInfo': {'id': '1411014943'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRIME care', 'description': 'Specialized care in the PRIME clinic', 'interventionNames': ['Other: PRIME care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'Usual care in the community', 'interventionNames': ['Other: Usual care']}], 'interventions': [{'name': 'PRIME care', 'type': 'OTHER', 'description': 'Specialist medication, cognitive behavior therapy, family-focused therapy', 'armGroupLabels': ['PRIME care']}, {'name': 'Usual care', 'type': 'OTHER', 'description': 'Medication and psychotherapy as available form community providers', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Prevention through Risk Identification Management and Education (PRIME) Clinic', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Scott Woods, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}