Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-03-09 @ 2:44 PM
Study NCT ID:
NCT00985933
Status:
COMPLETED
Last Update Posted:
2011-05-04
First Post:
2009-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects AZD8529 on Ketamine-induced Impairment of Working Memory in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008569', 'term': 'Memory Disorders'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000608263', 'term': 'AZD8529'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-03', 'studyFirstSubmitDate': '2009-09-25', 'studyFirstSubmitQcDate': '2009-09-28', 'lastUpdatePostDateStruct': {'date': '2011-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fMRI', 'timeFrame': '3'}, {'measure': 'Ketamine Infusion', 'timeFrame': '3'}], 'secondaryOutcomes': [{'measure': 'Clinician Administered Dissociative States Scale (CADSS)'}, {'measure': 'Positive and Negative Syndrome Scale (PANSS)'}, {'measure': 'Laboratory assessment: electrocardiogram (ECG), physical exam, vital signs, collection of adverse events'}]}, 'conditionsModule': {'keywords': ['Healthy normal volunteers'], 'conditions': ['Healthy', 'Memory Impairment']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess if ketamine will induce, in healthy volunteers, impairment of working memory and if the drug AZD8529 will block the effects of ketamine on working memory as assessed by functional magnetic resonance imaging (fMRI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Right handed\n* 12th grade education or equivalent\n* Able to read and write English as primary language\n\nExclusion Criteria:\n\n* History of head injury\n* Substance abuse or dependence\n* History of claustrophobia'}, 'identificationModule': {'nctId': 'NCT00985933', 'briefTitle': 'The Effects AZD8529 on Ketamine-induced Impairment of Working Memory in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Single Center, Double-Blind, Randomized, Double Dummy, Placebo-Controlled, Three-Period Crossover Study to Assess the Effects of a mGluR2/3 Positive Allosteric Modulator [AZD8529] Upon Ketamine-Induced Cortical Stimulation and Impairment of Working-Memory Related Activation of the Prefrontal Cortex', 'orgStudyIdInfo': {'id': 'D2285M00015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '180 mg of AZD8529', 'interventionNames': ['Drug: AZD8529', 'Drug: Placebo to match AZD8529']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '50 mg AD8529', 'interventionNames': ['Drug: AZD8529', 'Drug: Placebo to match AZD8529']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Placebo', 'interventionNames': ['Drug: AZD8529', 'Drug: Placebo to match AZD8529']}], 'interventions': [{'name': 'AZD8529', 'type': 'DRUG', 'description': '6 capsules by mouth 1 time 12 to 24 prior to assessments', 'armGroupLabels': ['1', '2', '3']}, {'name': 'Placebo to match AZD8529', 'type': 'DRUG', 'description': '6 capsules by mouth 1 time 12 to 24 hours prior to assessments', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'John Krystal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chair, Department of PsychiatryYale University School of MedicineChief of Psychiatry, Yale-New Haven Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'MSD', 'oldOrganization': 'AstraZeneca'}}}}