Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT00069433
Status:
COMPLETED
Last Update Posted:
2013-09-24
First Post:
2003-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Enhancing the Outcome of Skills Training for People With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-23', 'studyFirstSubmitDate': '2003-09-24', 'studyFirstSubmitQcDate': '2003-10-08', 'lastUpdatePostDateStruct': {'date': '2013-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Psychotic Disorders'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'This study will determine the effectiveness of skills training in people with schizophrenia and the applicability of the acquired skills in the "real world."', 'detailedDescription': 'People with schizophrenia have a large number of social and symptom management training programs available to them. Studies suggest that these training programs are effective, but their generalizability and effectiveness in outpatient settings has not been thoroughly examined. This study will examine the treatment outcomes of a skills training approach in schizophrenic individuals taking antipsychotic medication.\n\nParticipants taking stable doses of risperidone, olanzapine, or quetiapine will be randomly assigned to receive either intensive symptom management and social skills training or group therapy for 12 months. A verbal memory test will be used to stratify the randomization procedure and to control for neurocognitive functioning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of schizophrenia or schizoaffective disorder for \\> 5 years\n* Use of stable dose risperidone, olanzapine, or quetiapine for at least 1 month with no planned medication changes\n* Social Behavior Scale (SBS) score \\> 45\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Intelligence Quotient \\< 70\n* Use of more than one antipsychotic medication\n* Use of benzodiazepines, tricyclic antidepressants, or anticholinergic medication commonly used to treat extrapyramidal symptoms\n* Diagnostic and Statistical Manual (DSM)-IV criteria for alcohol or other substance dependence\n* History of any traumatic brain injury leading to loss of consciousness for \\> 30 minutes\n* Diagnosis of a comorbid medical condition that could interfere with antipsychotic medication treatment or the ability to complete the study'}, 'identificationModule': {'nctId': 'NCT00069433', 'briefTitle': 'Enhancing the Outcome of Skills Training for People With Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'New York State Psychiatric Institute'}, 'officialTitle': 'Skills Training for Schizophrenia: Enhancing Outcomes', 'orgStudyIdInfo': {'id': '#4339'}, 'secondaryIdInfos': [{'id': 'R01MH066362', 'link': 'https://reporter.nih.gov/quickSearch/R01MH066362', 'type': 'NIH'}, {'id': 'DSIR AT-SP'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Social skills and symptom management training', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06606', 'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hall-Brooke-The Center', 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}, {'zip': '06880', 'city': 'Westport', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hall-Brooke Behavioral Health Services', 'geoPoint': {'lat': 41.14149, 'lon': -73.3579}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York State Psychiatric Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}