F-18 Altanserin PET Study of Patients Receiving Clozapine

Schizophrenia Clinical Trial

— APC  

Official title:

Validation of Molecular Imaging Technologies for Early Clinical Trials

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01398189
• Other study ID #: SNUBH 04-2011-050
• Status: Recruiting
• Phase: N/A
• First received: July 19, 2011
• Last updated: November 19, 2013
• Start date: July 2011
• Est. completion date: July 2015

Study information

• Verified date: November 2013
• Source: Seoul National University Bundang Hospital
• Contact: Jae Seung Chang, MD, PhD
• Phone: 82 31 787 7437
• Email: cjs0107[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationKorea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To examine the feasibility of molecular imaging markers in clinical psychopharmacology

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 45 Years

Eligibility

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

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• clozapine
C-11 clozapine

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pharmacodynamics of F-18 artanserin	PET imaging with F-18 altanserin infusion	84 days	No
Secondary	serum level of clozapine and metabolites	dose-response relationship between clozapine and receptor occupancy	84 days	No