Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-02-28 @ 5:29 AM
Study NCT ID:
NCT02884518
Status:
UNKNOWN
Last Update Posted:
2019-09-24
First Post:
2016-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicting Antipsychotic Discontinuation in Psychosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073216', 'term': 'Mental Status and Dementia Tests'}], 'ancestors': [{'id': 'D009483', 'term': 'Neuropsychological Tests'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-23', 'studyFirstSubmitDate': '2016-08-04', 'studyFirstSubmitQcDate': '2016-08-30', 'lastUpdatePostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ki(cer) of 3,4-dihydroxy-6-18-fluoro-l-phenylalanine ([18 fluorine(F)]DOPA PET)', 'timeFrame': 'Change from Baseline Ki(cer) of [18 fluorine(F)]DOPA PET at 7 weeks and at 8 weeks', 'description': 'Subjects in the patient group will receive a reduced intake of antipsychotics by 25% after each week of the six-week period in which they will also undergo PET imaging at the baseline and six-week marks to detect the correlation between the capacity of presynaptic dopamine and relapse in the patients discontinuing treatment.'}], 'secondaryOutcomes': [{'measure': 'Positive and Negative Syndrome Scale(PANSS)Scale', 'timeFrame': 'at 0, 2, 4, 6, and 8 wk', 'description': 'Psychotic symptoms will be assessed by using PANSS at 0, 2, 4, 6, and 8 wk'}, {'measure': 'Brief Psychiatric Rating Scale(BPRS)', 'timeFrame': 'at 0, 2, 4, 6, and 8 wk', 'description': 'Psychotic symptoms will be assessed by using BPRS at 0, 2, 4, 6, and 8 wk'}, {'measure': 'Young Mania Rating Scale(YMRS)', 'timeFrame': 'at 0, 2, 4, 6 and 8 wk', 'description': 'Mood symptoms will be assessed by using YMRS at 0, 2, 4, 6 and 8 wk'}, {'measure': 'Hamilton Depression Rating Scale(HAM-D)', 'timeFrame': 'at 0, 2, 4, 6 and 8 wk', 'description': 'Mood symptoms will be assessed by using HAM-D at 0, 2, 4, 6 and 8 wk'}, {'measure': 'Columbia Suicide Severity Rating Scale(C-SSR)', 'timeFrame': 'at 0, 2, 4, 6, and 8 wk', 'description': 'Suicide risk will be assessed by using C-SSR at 0, 2, 4, 6, and 8 wk'}, {'measure': 'Quality of Life Scale(QoL)', 'timeFrame': 'at 0 , 4 and 8 wk', 'description': 'QoL will be assessed at 0 , 4 and 8 wk'}, {'measure': 'Adverse effects', 'timeFrame': 'at 0 and 4 wk', 'description': 'Adverse effects will be assessed by using side effect rating scale at 0 and 4 wk'}, {'measure': 'Kv-Subjective Well-Being Under Neuroleptics Scale(SWN)-K', 'timeFrame': 'at 0, 4 and 8 wk', 'description': 'Dysphoria will be assessed by using Kv-SWN-K at 0, 4 and 8 wk'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dopamine receptor occupancy', 'antipsychotics', 'positron emission tomography'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether dopamine synthesis capacity by using \\[18 fluorine(F)\\]-DOPA PET for patients with schizophrenia in the maintenance phase can predict treatment discontinuation.', 'detailedDescription': 'There are two groups: the healthy control group (n=12) and the patient group (n=26). The patient group recruits subjects diagnosed with first episode psychosis which occurred within 2 years and having been treated with antipsychotics for 1 year. Participants will complete clinical scales and undergo PET scans. Subjects in the patient group will receive a reduced intake of antipsychotics by 25% after each week of the four-week period in which they will also undergo PET imaging at the baseline, 7 week, and 8 week marks to detect the correlation between the capacity of presynaptic dopamine and relapse in the patients discontinuing treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Patient group\n\n1. Patients who met DSM-IV criteria for schizophrenia, schizoaffective disorder, and schizophreniform disorder\n2. patients diagnosed with first episode psychosis which occurred within 2 years and having been treated with antipsychotics for at least 1 year.\n3. Patients who have maintained in the stable state for 3 months without medication change at the baseline.\n\n2\\. Healthy control group\n\n* Healthy controls has no Axis I disorder and do not report any past event of neurological or psychiatric illness assessed by the Structured Clinical Interview for DSM Disorders\n\nExclusion Criteria:\n\n1. Participants should not have any neurological illness such as head trauma, seizure and meningitis.\n2. Participants should not be diagnosed as Mental retardation(IQ\\<70)\n3. Participants should not have severe personality disorder, substance abuse or dependence (except for nicotine abuse and dependence) and severe medical conditions.'}, 'identificationModule': {'nctId': 'NCT02884518', 'acronym': 'PADP', 'briefTitle': 'Predicting Antipsychotic Discontinuation in Psychosis', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Predicting Successful Antipsychotic Discontinuation in the First Episode Psychosis by Using Positron Emission Tomography(PET) withPositron Emission Tomography With 3,4-dihydroxy-6-18-fluoro-l-phenylalanine ([18 Fluorine(F)]DOPA)', 'orgStudyIdInfo': {'id': '[18F]DOPA PET-1000-1.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patient group', 'description': 'The patient group recruits subjects diagnosed with first episode psychosis which occurred within 2 years and having been treated with antipsychotics for 1 year. Subjects in the patient group will receive a reduced intake of antipsychotics by 25% after each week of the four-week period in which they will also undergo PET imaging at the baseline, 7 week, and 8 week marks to detect the correlation between the capacity. And patient group should complete clinical scales at 0, 2, 4, 6, and 8 week.', 'interventionNames': ['Device: PET', 'Behavioral: clinical scale']}, {'type': 'OTHER', 'label': 'healthy control group', 'description': 'Screening tests for healthy volunteers included physical examination, vital signs, laboratory will test (hematology, blood chemistry, and urinalysis), and a 12-lead electrocardiograms. A psychiatric interview with the Structured Clinical Interview for text revision of the Diagnostic and Statistical Manual of Mental Disorders -IV(DSM-IV-TR) Axis I disorders, Research Version, Nonpatient Edition (SCID-I/NP) (First et al. 2002) will be conducted. Subjects with any medically significant abnormality on investigations and/or psychiatric disease will be excluded. Also, healthy control group will take a PET scan at 0, 2, 4, 6, and 8 week and clinical scales at baseline.', 'interventionNames': ['Device: PET', 'Behavioral: clinical scale']}], 'interventions': [{'name': 'PET', 'type': 'DEVICE', 'description': 'Subjects in the patient group will receive a reduced intake of antipsychotics by 25% after each week of the four-week period in which they and healthy controls will also undergo PET imaging at the baseline, 7 week, and 8 week marks to detect the correlation between the capacity of presynaptic dopamine and relapse in the patients discontinuing treatment.', 'armGroupLabels': ['healthy control group', 'patient group']}, {'name': 'clinical scale', 'type': 'BEHAVIORAL', 'description': 'Healthy controls should complete clinical scales at baseline. Patient group should complete clinical scales at 0, 2, 4, 6, and 8 week.', 'armGroupLabels': ['healthy control group', 'patient group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Euitae Kim, Ph. D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Euitae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}