Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-06 @ 11:12 AM
Study NCT ID:
NCT01490567
Status:
UNKNOWN
Last Update Posted:
2011-12-13
First Post:
2011-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Double-blind, Placebo-controlled Trial of Donepezil Adjunctive Treatment for Cognitive Impairment in Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077265', 'term': 'Donepezil'}], 'ancestors': [{'id': 'D007189', 'term': 'Indans'}, {'id': 'D007192', 'term': 'Indenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-12-09', 'studyFirstSubmitDate': '2011-11-09', 'studyFirstSubmitQcDate': '2011-12-09', 'lastUpdatePostDateStruct': {'date': '2011-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in the Composite Score From the Cognition Assessment Battery After 12 Weeks of Treatment', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in Cognition Assessment scores After 12 Weeks of Treatment', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Impaired Cognition Schizophrenia'], 'conditions': ['Impaired Cognition', 'Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The objective of the study was to study the effects of donepezil on cognition in patients with schizophrenia. The investigators conducted a 12-week, double-blind, placebo-controlled trial of donepezil as adjunctive treatment to antipsychotic drugs on patients with schizophrenia.', 'detailedDescription': 'The investigators conducted a 12-week, double-blind, placebo-controlled trial of donepezil as adjunctive treatment to antipsychotic drugs on patients with schizophrenia.The trial will be complete in 2012.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* DSM-IV diagnosis of schizophrenia as determined by the Structured Clinical Interview for DSM-IV Axis I Disorders-Clinician Version;\n* Between 18 and 40 years of age;\n* Duration of the illness must be longer than 2 year;\n* Patient's current antipsychotic medication regimen must be stable;\n* Must be in a stable living arrangement;\n\nExclusion Criteria:\n\n* Patient has mental retardation or severe organic brain syndromes;\n* Treatment with Electroconvulsive Therapy (ECT) within 6 months prior to screening;\n* Has suicidal attempts or ideation or violent behavior within the last 12 months;\n* Patient has a history of alcohol/drug dependence;"}, 'identificationModule': {'nctId': 'NCT01490567', 'briefTitle': 'A Double-blind, Placebo-controlled Trial of Donepezil Adjunctive Treatment for Cognitive Impairment in Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Central South University'}, 'officialTitle': 'Donepezil Adjunctive Treatment for Cognitive Impairment in Schizophrenia', 'orgStudyIdInfo': {'id': 'NSFC30900485'}, 'secondaryIdInfos': [{'id': '201002003', 'type': 'OTHER_GRANT', 'domain': 'the R&D Special Fund for Health Profession in China'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Subjects will be given with a dose of 5mg/day placebo. All drugs will be administered orally.', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'donepezil', 'description': 'Subjects will be given with a dose of 5 mg/day donepezil. All drugs will be administered orally.', 'interventionNames': ['Drug: Donepezil']}], 'interventions': [{'name': 'Donepezil', 'type': 'DRUG', 'otherNames': ['Donepezil hydrochloride'], 'description': '5 mg/day', 'armGroupLabels': ['donepezil']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo 5mg/d', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410011', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaofeng Guo, Doctor', 'role': 'CONTACT', 'email': 'gxfd@sina.com.cn', 'phone': '86-731-85554052'}], 'facility': 'the Second Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'overallOfficials': [{'name': 'Xiaofeng Guo, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Xiangya Hospital of Central South University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'xiaofeng Guo', 'investigatorAffiliation': 'Central South University'}}}}