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F-18 Altanserin PET Study of Patients Receiving Clozapine

NCT ID: NCT01398189

Last Updated: 2013-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2015-07-31

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.

Conditions

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Schizophrenia Schizoaffective Disorder

Keywords

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clozapine PET schizophrenia schizoaffective disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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clozapine

patients with refractory schizophrenia or schizoaffective disorder

Group Type EXPERIMENTAL

clozapine

Intervention Type DRUG

C-11 clozapine

Interventions

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clozapine

C-11 clozapine

Intervention Type DRUG

Other Intervention Names

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clozaril

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jae Seung Chang

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jae Seung Chang, MD, PhD

Role: STUDY_DIRECTOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jae Seung Chang, MD, PhD

Role: CONTACT

Phone: 82 31 787 7437

Email: [email protected]

Se Young Lee, MD

Role: CONTACT

Phone: 82 31 787 7439

Email: [email protected]

Facility Contacts

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Se Young Lee, MD

Role: primary

Other Identifiers

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SNUBH 04-2011-050

Identifier Type: -

Identifier Source: org_study_id