Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT00071604
Status:
UNKNOWN
Last Update Posted:
2013-05-06
First Post:
2003-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Medication Adherence in Older People With Psychosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D012559', 'term': 'Schizophrenia'}], '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': 'DOUBLE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2007-05'}, 'lastUpdateSubmitDate': '2013-05-03', 'studyFirstSubmitDate': '2003-10-29', 'studyFirstSubmitQcDate': '2003-10-29', 'lastUpdatePostDateStruct': {'date': '2013-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-10-30', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Psychotic Disorders', 'Schizophrenia']}, 'descriptionModule': {'briefSummary': 'This study will determine whether Medication Adherence Therapy (MAT) can improve medication adherence and lower the risk of rehospitalization in older patients with psychosis.', 'detailedDescription': 'Psychoses are among the most common and serious psychiatric disorders. Currently, the most effective treatment for psychoses involves the use of antipsychotic or neuroleptic medications. Unfortunately, pharmacologic regimens often do not achieve their goals because of poor medication adherence. Nonadherence to antipsychotic treatment is a considerable public health problem that leads to myriad clinical and economic burdens, including psychotic relapse, increased clinic and emergency room visits, and rehospitalization.\n\nParticipants in this study are randomly assigned to receive either MAT or supportive treatment for 12 weeks. MAT is given in 15 sessions and consists of motivational interviewing, education, and social skills and behavior modification. Individual MAT sessions are held in Weeks 1 and 12; small group sessions take place in Weeks 2 through 11. Three monthly booster group sessions begin in Week 16. Participants are assessed at baseline and at 3, 6, and 12 months. Medication adherence, psychopathology, quality of life, medication side effects, health beliefs, and functioning are assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DSM-IV criteria for schizophrenia or schizoaffective disorder\n* Outpatient status at the time of enrollment\n* Currently prescribed maintenance treatment with antipsychotic medication (typical or atypical, oral or depot)'}, 'identificationModule': {'nctId': 'NCT00071604', 'briefTitle': 'Medication Adherence in Older People With Psychosis', 'organization': {'class': 'OTHER', 'fullName': 'Veterans Medical Research Foundation'}, 'officialTitle': 'Medication Adherence in Older Psychotic People', 'orgStudyIdInfo': {'id': 'R01MH062849', 'link': 'https://reporter.nih.gov/quickSearch/R01MH062849', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH062849', 'link': 'https://reporter.nih.gov/quickSearch/R01MH062849', 'type': 'NIH'}, {'id': 'DATR A4-GPS'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Medication Adherence Therapy', 'type': 'BEHAVIORAL'}, {'name': 'Friendly Support Group', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Division of Geriatric Psychiatry Center (University of California, San Diego)', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Jonathan Lacro, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA San Diego Healthcare System & University of California, San Diego'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Veterans Medical Research Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}]}}}