F-18 Altanserin PET Study of Patients Receiving Clozapine

Not Applicable

• Conditions: Schizophrenia; Schizoaffective Disorder
• Interventions: Drug: clozapine

• Registration Number: NCT01398189
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-19
• Study First Submitted QC: 2011-07-19
• Study First Posted: 2011-07-20
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-19
• Last Update Posted: 2013-11-21
• Primary Completion: 2015-07
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
clozapine	clozapine	patients with refractory schizophrenia or schizoaffective disorder

Primary Outcome Measures

Name	Time	Method
pharmacodynamics of F-18 artanserin	84 days	PET imaging with F-18 altanserin infusion

Secondary Outcome Measures

Name	Time	Method
serum level of clozapine and metabolites	84 days	dose-response relationship between clozapine and receptor occupancy

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of