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

This study is currently recruiting participants.
Verified April 2013 by Seoul National University Bundang Hospital
Sponsor:
Information provided by (Responsible Party):
Jae Seung Chang, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01398189
First received: July 19, 2011
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
  Purpose

To examine the feasibility of molecular imaging markers in clinical psychopharmacology


Condition Intervention
Schizophrenia
Schizoaffective Disorder
 Drug: clozapine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Validation of Molecular Imaging Technologies for Early Clinical Trials

Resource links provided by NLM:

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

Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • pharmacodynamics of F-18 artanserin [ Time Frame: 84 days ] [ Designated as safety issue: No ]
    PET imaging with F-18 altanserin infusion


Secondary Outcome Measures:
  • serum level of clozapine and metabolites [ Time Frame: 84 days ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   19 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398189

Contacts
Contact: Jae Seung Chang, MD, PhD 82 31 787 7437 cjs0107@gmail.com
Contact: Se Young Lee, MD 82 31 787 7439 zoayo2000@hanmail.net

Locations
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     zoayo2000@hanmail.net    
Principal Investigator: Kyooseob Ha, MD, PhD            
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Study Director: Jae Seung Chang, MD, PhD Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Jae Seung Chang, Clinical Assistant Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01398189     History of Changes
Other Study ID Numbers: SNUBH 04-2011-050
Study First Received: July 19, 2011
Last Updated: April 12, 2013
Health Authority: Korea: Food and Drug Administration
Korea: Institutional Review Board

Keywords provided by Seoul National University Bundang Hospital:
clozapine
PET
schizophrenia
schizoaffective disorder

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Clozapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
GABA Antagonists
GABA Agents

ClinicalTrials.gov processed this record on May 23, 2013