Status:
UNKNOWN
F-18 Altanserin PET Study of Patients Receiving Clozapine
Lead Sponsor:
Seoul National University Bundang Hospital
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
19-45 years
Phase:
NA
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 psychopatho...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2015
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01398189
Start Date
July 1 2011
End Date
July 1 2015
Last Update
November 21 2013
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 463-707