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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by Jae Seung Chang, Seoul National University Bundang Hospital.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Jae Seung Chang, Seoul National University Bundang Hospital Identifier:
First received: July 19, 2011
Last updated: November 19, 2013
Last verified: November 2013
To examine the feasibility of molecular imaging markers in clinical psychopharmacology

Condition Intervention
Schizophrenia Schizoaffective Disorder Drug: clozapine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Validation of Molecular Imaging Technologies for Early Clinical Trials

Resource links provided by NLM:

Further study details as provided by Jae Seung Chang, Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • pharmacodynamics of F-18 artanserin [ Time Frame: 84 days ]
    PET imaging with F-18 altanserin infusion

Secondary Outcome Measures:
  • serum level of clozapine and metabolites [ Time Frame: 84 days ]
    dose-response relationship between clozapine and receptor occupancy

Estimated Enrollment: 12
Study Start Date: July 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: clozapine
patients with refractory schizophrenia or schizoaffective disorder
Drug: clozapine
C-11 clozapine
Other Name: clozaril

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.

Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01398189

Contact: Jae Seung Chang, MD, PhD 82 31 787 7437
Contact: Se Young Lee, MD 82 31 787 7439

Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi, Korea, Republic of, 463-707
Contact: Se Young Lee, MD    82 31 787 7439   
Principal Investigator: Kyooseob Ha, MD, PhD         
Sponsors and Collaborators
Seoul National University Bundang Hospital
Study Director: Jae Seung Chang, MD, PhD Seoul National University Bundang Hospital
  More Information

Responsible Party: Jae Seung Chang, Clinical Assistant Professor, Seoul National University Bundang Hospital Identifier: NCT01398189     History of Changes
Other Study ID Numbers: SNUBH 04-2011-050
Study First Received: July 19, 2011
Last Updated: November 19, 2013

Keywords provided by Jae Seung Chang, Seoul National University Bundang Hospital:
schizoaffective disorder

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
GABA Antagonists
GABA Agents processed this record on August 17, 2017