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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01398189
Recruitment Status : Unknown
Verified November 2013 by Jae Seung Chang, Seoul National University Bundang Hospital.
Recruitment status was:  Recruiting
First Posted : July 20, 2011
Last Update Posted : November 21, 2013
Information provided by (Responsible Party):
Jae Seung Chang, Seoul National University Bundang Hospital

Brief Summary:
To examine the feasibility of molecular imaging markers in clinical psychopharmacology

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: clozapine Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Validation of Molecular Imaging Technologies for Early Clinical Trials
Study Start Date : July 2011
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Clozapine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: clozapine
patients with refractory schizophrenia or schizoaffective disorder
Drug: clozapine
C-11 clozapine
Other Name: clozaril

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: July 20, 2011    Key Record Dates
Last Update Posted: November 21, 2013
Last Verified: November 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