F-18 Altanserin PET Study of Patients Receiving Clozapine (APC)

November 19, 2013 updated by: Jae Seung Chang, Seoul National University Bundang Hospital

Validation of Molecular Imaging Technologies for Early Clinical Trials

To examine the feasibility of molecular imaging markers in clinical psychopharmacology

Study Overview

Status

Unknown

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jae Seung Chang, MD, PhD
  • Phone Number: 82 31 787 7437
  • Email: cjs0107@gmail.com

Study Contact Backup

Study Locations

    • Gyeonggi
      • Seongnam, Gyeonggi, Korea, Republic of, 463-707
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Principal Investigator:
          • Kyooseob Ha, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: clozapine
patients with refractory schizophrenia or schizoaffective disorder
C-11 clozapine
Other Names:
  • clozaril

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pharmacodynamics of F-18 artanserin
Time Frame: 84 days
PET imaging with F-18 altanserin infusion
84 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum level of clozapine and metabolites
Time Frame: 84 days
dose-response relationship between clozapine and receptor occupancy
84 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Jae Seung Chang, MD, PhD, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ANTICIPATED)

July 1, 2015

Study Completion (ANTICIPATED)

July 1, 2015

Study Registration Dates

First Submitted

July 19, 2011

First Submitted That Met QC Criteria

July 19, 2011

First Posted (ESTIMATE)

July 20, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 21, 2013

Last Update Submitted That Met QC Criteria

November 19, 2013

Last Verified

November 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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