Status:
TERMINATED
Positron Emission Tomography (PET) Imaging of Glial Activation in Psychotic Disease States
Lead Sponsor:
Johns Hopkins University
Conditions:
Schizophrenia
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Many neurological diseases, including AIDS dementia, Alzheimer's disease and schizophrenia, involve an inflammatory component thought to specifically involve glial cell activation. The Investigators h...
Eligibility Criteria
Inclusion
- healthy volunteers 18-65 years of age
- Patients diagnosed with recent onset schizophrenia (within 5 years of onset), 18-65 years of age
- Patients diagnosed with recent onset bipolar disorder (within 5 years of onset of first mania), 18-65 years of age
- 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
- EKG conducted within 10 day period prior to the PET study. The EKG will be repeated within 7 days following the study.
- Subject agrees to return to the Hospital for a follow-up EKG and laboratory testing of blood and urine.
- For females of childbearing potential, negative serum pregnancy test within a 10 day period prior to PET study.
Exclusion
- history of recent nosocomial infection,
- history of chronic neurological disorder, such as multiple sclerosis or epilepsy, or structural,central nervous system (CNS) abnormality such as stroke or arteriovenous malformation,
- history of head injury with loss of consciousness \> 1 hour,
- history of active substance abuse as defined by substance abuse including alcohol abuse over the 6 months prior to the study,
- dependence on benzodiazepine medication
- contraindications to MRI scanning to include pacemakers, metallic implants/prosthesis or prohibitive claustrophobia, etc.
- 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
- ECG demonstrating the patient is not in a sinus rhythm or is having acute ischemia.
- any medical condition that in the opinion of the study investigators would constitute a safety risk to the subject.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03257592
Start Date
August 1 2010
End Date
April 1 2018
Last Update
September 10 2020
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287