Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
clozapine, PET, schizophrenia, schizoaffective disorder
Brief summary
To examine the feasibility of molecular imaging markers in clinical psychopharmacology
Detailed description
Clinical evaluation of patients with psychiatric disorders is mainly dependent on patients' reports and clinicians' observations. In order to develop objective and quantifiable measures of psychopathology, molecular imaging techniques will be used in patients receiving clozapine.
Interventions
DRUGclozapine
C-11 clozapine
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Overtly healthy males as determined by medical history and physical examination * Age from 19 to 45 years * Weight ≥ 45 kg and within ± 20% of IBW * Clinical laboratory test results within normal reference range for the National Cancer Center, Hospital or results with minor deviations which are judged to be not clinically significant by the investigator * Normal blood pressure and heart rate (supine and standing) as determined by the investigator * Are reliable and willing to make themselves available for the duration of the study, and who will abide by the study restrictions * Have given written informed consent
Exclusion criteria
* Evidence of significant active hematologic disease * History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, neurological disorders capable of altering the absorption, metabolism or elimination of drugs, or of constituting a risk factor when taking the study medication * An episode of febrile disease or infectious disease within the past 2 weeks * Evidence of significant active neuropsychiatric disease * Regular use of drugs or abuse * History of drug hypersensitivity or clinically significant allergic reactions of any origin * Participation in a study involving administration of an investigational compound within the past 30 days * Use of any current medication * Smoking history for recent 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pharmacodynamics of F-18 artanserin | 84 days | PET imaging with F-18 altanserin infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| serum level of clozapine and metabolites | 84 days | dose-response relationship between clozapine and receptor occupancy |
Countries
South Korea
Contacts
Primary ContactJae Seung Chang, MD, PhD
Backup ContactSe Young Lee, MD
Outcome results
None listed