F-18 Altanserin PET Study of Patients Receiving Clozapine

Study Overview
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Brief Summary
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To examine the feasibility of molecular imaging markers in clinical psychopharmacology

Detailed Description
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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.

Official Title
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Validation of Molecular Imaging Technologies for Early Clinical Trials

Conditions
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Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
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* Drug: clozapine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: clozapine<br>patients with refractory schizophrenia or schizoaffective disorder | Drug: clozapine<br>* C-11 clozapine<br>* Other names: clozaril;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacodynamics of F-18 artanserin | PET imaging with F-18 altanserin infusion | 84 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum level of clozapine and metabolites | dose-response relationship between clozapine and receptor occupancy | 84 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clozapine, PET, schizophrenia, schizoaffective disorder