APC: F-18 Altanserin PET Study of Patients Receiving Clozapine

Sponsor

Seoul National University Bundang Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01398189

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To examine the feasibility of molecular imaging markers in clinical psychopharmacology

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Schizoaffective Disorder	Drug: clozapine	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Validation of Molecular Imaging Technologies for Early Clinical Trials

Study Start Date :

Jul 1, 2011

Anticipated Primary Completion Date :

Jul 1, 2015

Anticipated Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: clozapine patients with refractory schizophrenia or schizoaffective disorder	Drug: clozapine C-11 clozapine Other Names: clozaril

Arm

Intervention/Treatment

Experimental: clozapine

patients with refractory schizophrenia or schizoaffective disorder

Drug: clozapine

C-11 clozapine

Other Names:

clozaril

Outcome Measures

Primary Outcome Measures

pharmacodynamics of F-18 artanserin [84 days]
PET imaging with F-18 altanserin infusion

Secondary Outcome Measures

serum level of clozapine and metabolites [84 days]
dose-response relationship between clozapine and receptor occupancy

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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