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F-18 Altanserin PET Study of Patients Receiving Clozapine | Clinical Trials | Clareo Health

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F-18 Altanserin PET Study of Patients Receiving Clozapine

Validation of Molecular Imaging Technologies for Early Clinical Trials

NCT01398189•Seoul National University Bundang Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

19 - 45 years

Sex

ALL

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

Locations (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Key Dates

Start Date

July 1, 2011

Primary Completion Date

July 1, 2015

Completion Date

July 1, 2015

Last Updated

November 21, 2013

Enrollment

ESTIMATED participants

Conditions

SchizophreniaSchizoaffective Disorder

Interventions

clozapine

DRUG

Contacts

Jae Seung Chang, MD, PhD

CONTACT

82 31 787 7437 cjs0107@gmail.com

Se Young Lee, MD

CONTACT

82 31 787 7439 zoayo2000@hanmail.net

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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F-18 Altanserin PET Study of Patients Receiving Clozapine

Inclusion Criteria

Exclusion Criteria

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