Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-04-14 @ 11:32 AM
Study NCT ID:
NCT00861003
Status:
UNKNOWN
Last Update Posted:
2009-03-13
First Post:
2009-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Adherence Study of Antipsychotic Medication in Outpatients With Schizophrenia or Schizoaffective Disorder
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 57}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2010-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-03-12', 'studyFirstSubmitDate': '2009-03-12', 'studyFirstSubmitQcDate': '2009-03-12', 'lastUpdatePostDateStruct': {'date': '2009-03-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence is assessed by four methods including Medication Event Monitoring System', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Various factors that have been identified as influencing adherence', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['schizophrenia', 'adherence'], 'conditions': ['Schizophrenia', 'Schizoaffective Disorder']}, 'descriptionModule': {'briefSummary': 'This prospective study examines the differences among several measures of adherence to antipsychotic medications in outpatients with schizophrenia. Adherence is assessed by using self-report, physician report, pill count and electronic monitoring. The rates of adherence/non-adherence with various tools will be manifested. The association between antipsychotic adherence/non-adherence and various clinical status, including psychotic symptoms, depressive symptoms, side effects, neurocognitive function and insight are analyzed. Participants are assessed at baseline during a visit to their outpatient clinic and followed up for 8 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Clinician rendered diagnosis of schizophrenia or schizoaffective disorder documented by a checklist of Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV) criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ability to provide written informed consent\n2. Male or female, aged from 20 to 65 years\n3. Clinician rendered diagnosis of schizophrenia or schizoaffective disorder documented by a checklist of Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV) criteria\n4. Currently taking a single oral antipsychotic (e.g., Quetiapine, Risperidone, Olanzapine, or Amisulpride).\n5. Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropine (HCG) test at enrolment\n6. Outpatient status, with psychiatric hospitalization or psychiatric emergency room visit within the previous 2 years and no hospitalizations within 3 months\n7. mild to moderate symptom checked by CGI-S (less than score 4)\n8. Able to understand and comply with the requirements of the study\n\nExclusion Criteria:\n\n1. Any DSM-IV Axis I disorder not defined in the inclusion criteria\n2. Presence of a co-morbid diagnosis that might influence outcome measures (e.g., mental retardation)\n3. Alcohol or substance dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria\n4. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others\n5. Pregnancy or lactation\n6. Evidence of hypersensitivity to Quetiapine or other antipsychotics used in the study\n7. Use of any cytochrome P450 inhibitors or inducers in the 14 days preceding enrolment\n8. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation\n9. use of pillbox\n10. Treatment with Clozapine (because of its unique monitoring guidelines)\n11. Administration of electroconvulsive therapy (ECT) in the last 6 months\n12. Unstable or inadequately treated medical condition such as heart, liver, kidney, or lung disease, or a seizure disorder\n13. Involvement in the planning and conduct of the other study.\n14. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements.'}, 'identificationModule': {'nctId': 'NCT00861003', 'acronym': 'MEMS-SPR', 'briefTitle': 'An Adherence Study of Antipsychotic Medication in Outpatients With Schizophrenia or Schizoaffective Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Guro Hospital'}, 'officialTitle': 'An Exploratory Study on Comparison of Electronic Monitoring and Other Measures of Adherence to Antipsychotic Medication in Outpatients With Schizophrenia or Schizoaffective Disorder', 'orgStudyIdInfo': {'id': 'KSH001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Schizophrenia, antipsychotics', 'description': 'Stable outpatient status of schizophrenia or schizoaffective disorder currently taking a single oral antipsychotic', 'interventionNames': ['Device: Medication Event Monitoring System (MEMS)']}], 'interventions': [{'name': 'Medication Event Monitoring System (MEMS)', 'type': 'DEVICE', 'description': 'MEMS is a medication vial cap that electronically records the date and time of bottle opening.', 'armGroupLabels': ['Schizophrenia, antipsychotics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '152-703', 'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Seung-Hyun Kim, M.D., Ph..D', 'role': 'CONTACT', 'email': 'psyche731@hanmail.net', 'phone': '02-2626-3162'}, {'name': 'Seung-Hyun Kim, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jaewon Yang, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University Guro Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Seung-Hyun Kim', 'oldOrganization': 'Professor'}}}}