Status:
COMPLETED
Functional Relevance of Dopamine Receptors in Healthy Controls and Patients With Schizophrenia: Characterization Through [11C]NNC-112 and [18F]Fallypride Positron Emission Tomography
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Schizoaffective Disorder
Schizophrenia
Eligibility:
All Genders
18-90 years
Brief Summary
Background: * Some illnesses, such as schizophrenia, have effects on brain cells called dopamine receptors, which are required for normal brain function. People with schizophrenia have difficulty thi...
Detailed Description
OBJECTIVES Dopaminergic (DA) modulation of brain function is disturbed in several disabling psychiatric disorders and represents the target of key psychopharmacologic agents, such as neuroleptics. Sc...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subjects will be recruited among individuals volunteering for NIH protocol 95-M-0150 A Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings (PI: Karen Berman, M.D.), NIH protocol 00-M-0085 Structural and Functional Imaging of Neuropsychiatric Patients and Normal Volunteers with 3.0 Tesla MRI and Magnetoencephalography. (P.I.: Karen Berman, MD) or NIH protocol 89-M-0160 "Inpatient Evaluation of Neuropsychiatric Patients" (PI: Daniel Eisenberg, M.D.). Most included patients, with schizophrenia, schizoaffective disorder or other non-excluded psychotic disorders, will be managed on the NIMH inpatient ward for the duration of their participation.
- Only adult subjects who are able to provide informed consent will be studied.
- Patients will be between 18 and 60 years of age. Healthy controls will be matched by age and sex to the patients. In addition, to study age effect on DA receptors, healthy controls will be included up to the age of 90 years.
- Control subjects must be healthy based on history, laboratory and physical exam obtained through the above mentioned protocols.
- EXCLUSION CRITERIA:
- Subjects will be excluded if they don t fit the study requirements regarding age, ability to provide informed consent, absence of significant general medical, neurological or psychiatric disorders (except the disorder object of study), or intake of substances that
- interfere with central dopaminergic signaling.
- NIMH employees and staff and their immediate family members will be excluded from the study per NIMH policy.
- Pregnant or breast feeding
- Current psychiatric illness except for patients with schizophrenia, schizoaffective disorder or other psychotic disorder
- Secondary causes of schizophrenia-like syndromes, e.g. amphetamine abuse, brain infarction, tumor, or trauma
- Neurological disorders except those of exclusively peripheral location
- Current or prior use (within 4 weeks) of substances that interfere with central dopaminergic signaling (e.g. antipsychotics, dopamine receptor agonists, anticholinergics, MAO-B inhibitors)
- History of any (excepting nicotine- related) DSM5-defined moderate to severe substance use disorder (or DSM-IV-defined substance dependence).
- Cumulative lifetime history of any (excepting nicotine -related) DSM5-defined mild substance use disorder (or any DSM-IV-defined substance abuse), either in excess of 5 years total or not in remission for at least 6 months.
- Severe systemic disease, such as hypothyroidism not compensated by medication
- Laboratory tests with clinically significant abnormalities
- History of a significantly abnormal EEG, cranial CT or MRI
- Conditions that increase risk for MRI (pacemaker devices, ferromagnetic metal implants, etc.)
- Prior participation in other research protocols such that radiation exposure would exceed the annual NIH RSC limits
- Any medical condition that in the opinion of the investigators would interfere with the safe conduct of the study
Exclusion
Key Trial Info
Start Date :
November 13 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
283 Patients enrolled
Trial Details
Trial ID
NCT00942981
Start Date
November 13 2009
Last Update
January 8 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892