Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-02-25 @ 4:15 AM
Study NCT ID:
NCT00528905
Status:
COMPLETED
Last Update Posted:
2008-11-25
First Post:
2007-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proof of Concept Study of Cognitive Improvement in Patients With Schizophrenia
Sponsor:
Organization:
Raw JSON
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'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-11-21', 'studyFirstSubmitDate': '2007-09-10', 'studyFirstSubmitQcDate': '2007-09-11', 'lastUpdatePostDateStruct': {'date': '2008-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Domain scores for Attention/Vigilance, Working Memory, Verbal Learning, Speed of Processing and Verbal Fluency as measured on the IntegNeuro computerized test battery of cognitive function', 'timeFrame': 'Change from baseline to Week 12'}], 'secondaryOutcomes': [{'measure': 'UCSD Performance Based Skills Assessment (UPSA2) and on the Social Functioning Scale (SFS)', 'timeFrame': 'Change from baseline to Week 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Cognitive Deficits'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate that AZD3480 improves cognition in patients with stable schizophrenia who are being treated with an atypical antipsychotic and who are active cigarette smokers, to assess the safety and tolerability of AZD3480 and to define the optimal dose(s) to be used in future trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of schizophrenia\n* Outpatient at the time of screening and randomization\n* Stable housing defined as having a place to live in the community (ie, not in a hospital or nursing home)\n* Active cigarette smoking (10 or more cigarettes per day\n\nExclusion Criteria:\n\n* Any significant psychiatric or neurological disease other than schizophrenia, or current diagnosis of major depressive disorder\n* Known or suspected drug or alcohol abuse within the 6 months or urine toxicology test positive for illegal or non-prescribed substances\n* Impaired vision and/or hearing making cognitive testing difficult'}, 'identificationModule': {'nctId': 'NCT00528905', 'acronym': 'HALO', 'briefTitle': 'Proof of Concept Study of Cognitive Improvement in Patients With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Multi-Center Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase IIb Proof of Concept Study With 3 Oral Groups of AZD3480 During 12 Weeks Treatment of Cognitive Deficits in Patients With Schizophrenia', 'orgStudyIdInfo': {'id': 'D3690C00011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Placebo', 'interventionNames': ['Drug: AZD3480']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'AZD3480 oral', 'interventionNames': ['Drug: AZD3480']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'AZD3480 oral dose', 'interventionNames': ['Drug: AZD3480']}], 'interventions': [{'name': 'AZD3480', 'type': 'DRUG', 'description': 'oral capsule', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'city': 'Cerritos', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.85835, 'lon': -118.06479}}, {'city': 'Costa Mesa', 'state': 'California', 'country': 'United 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