Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2026-01-31 @ 1:41 PM
Study NCT ID:
NCT03257592
Status:
TERMINATED
Last Update Posted:
2020-09-10
First Post:
2017-08-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Positron Emission Tomography (PET) Imaging of Glial Activation in Psychotic Disease States
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'whyStopped': 'Lack of funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-08', 'studyFirstSubmitDate': '2017-08-15', 'studyFirstSubmitQcDate': '2017-08-18', 'lastUpdatePostDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and Specificity of ([11C]DPA)-713 PET brain imaging in patients with recent onset schizophrenia and in patients with recent onset of mania', 'timeFrame': 'within five years of onset of schizophrenia or within five years of first manic episode', 'description': 'To determine regional brain uptake of this radioligand in patients with recent onset schizophrenia and in patients with recent onset of mania'}], 'secondaryOutcomes': [{'measure': 'PET Imaging of microglial activation', 'timeFrame': '5 years', 'description': 'To evaluate changes in activation of microglia in patients with acute schizophrenia and bipolar disorder relative to controls'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Bipolar Disorder']}, 'descriptionModule': {'briefSummary': "Many neurological diseases, including AIDS dementia, Alzheimer's disease and schizophrenia, involve an inflammatory component thought to specifically involve glial cell activation. The Investigators has been concerned with the development of tools for noninvasive imaging of inflammatory processes in psychotic disease. Here, the investigators aim to use PET-based neuroimaging with carbon-11 N,N-diethyl-2-(4-methoxyphenyl)-5,7-dimethylpyrazolo\\[1,5-a\\]pyrimidine-3-acetamide, (\\[11C\\]DPA)-713 to quantify regional distribution of translocator protein (TSPO), a putative marker of inflammation, in the brains of patients with schizophrenia and bipolar disorder, type I. The investigators will focus on patients in the early stages of disease (within first five years of onset of schizophrenia diagnosis and within first five years of first manis, respectively) to minimize the confounds of age-, chronic illness-, and medication- effects on our results."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteers 18-65 years of age\n* Patients diagnosed with recent onset schizophrenia (within 5 years of onset), 18-65 years of age\n* Patients diagnosed with recent onset bipolar disorder (within 5 years of onset of first mania), 18-65 years of age\n* screening laboratory tests will be obtained for subjects within a 10 day period prior to the PET study and the results must be within normal limits for gender and age. These tests will be repeated with a 7-day window following the PET study\n* EKG conducted within 10 day period prior to the PET study. The EKG will be repeated within 7 days following the study.\n* Subject agrees to return to the Hospital for a follow-up EKG and laboratory testing of blood and urine.\n* For females of childbearing potential, negative serum pregnancy test within a 10 day period prior to PET study.\n\nExclusion Criteria:\n\n* history of recent nosocomial infection,\n* history of chronic neurological disorder, such as multiple sclerosis or epilepsy, or structural,central nervous system (CNS) abnormality such as stroke or arteriovenous malformation,\n* history of head injury with loss of consciousness \\> 1 hour,\n* history of active substance abuse as defined by substance abuse including alcohol abuse over the 6 months prior to the study,\n* dependence on benzodiazepine medication\n* contraindications to MRI scanning to include pacemakers, metallic implants/prosthesis or prohibitive claustrophobia, etc.\n* contraindications to PET scanning to include pregnancy, etc. For females of childbearing potential, negative serum pregnancy test less than 10 days prior to PET study\n* ECG demonstrating the patient is not in a sinus rhythm or is having acute ischemia.\n* any medical condition that in the opinion of the study investigators would constitute a safety risk to the subject.'}, 'identificationModule': {'nctId': 'NCT03257592', 'briefTitle': 'Positron Emission Tomography (PET) Imaging of Glial Activation in Psychotic Disease States', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'PET Imaging of Glial Activation in Psychotic Disease States', 'orgStudyIdInfo': {'id': 'NA_00037683'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with Schizophrenia Disorder', 'description': 'Patients with Schizophrenia Disorder will be imaged with \\[11C\\] DPA-713', 'interventionNames': ['Drug: [11C]DPA-713']}, {'type': 'EXPERIMENTAL', 'label': 'Patients with Bipolar Disorder', 'description': 'Patients with Bipolar Disorder will be imaged with \\[11C\\] DPA-713', 'interventionNames': ['Drug: [11C]DPA-713']}, {'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'Normal volunteers will be imaged with \\[11C\\] DPA-713', 'interventionNames': ['Drug: [11C]DPA-713']}], 'interventions': [{'name': '[11C]DPA-713', 'type': 'DRUG', 'description': '\\[11C\\]DPA-713 PET imaging', 'armGroupLabels': ['Control', 'Patients with Bipolar Disorder', 'Patients with Schizophrenia Disorder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Martin Pomper, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}