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

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
clozapine
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Schizophrenia focused on measuring clozapine, PET, schizophrenia, schizoaffective disorder

Eligibility Criteria

19 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

clozapine

Arm Description

patients with refractory schizophrenia or schizoaffective disorder

Outcomes

Primary Outcome Measures

pharmacodynamics of F-18 artanserin
PET imaging with F-18 altanserin infusion

Secondary Outcome Measures

serum level of clozapine and metabolites
dose-response relationship between clozapine and receptor occupancy

Full Information

First Posted
July 19, 2011
Last Updated
November 19, 2013
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01398189
Brief Title
F-18 Altanserin PET Study of Patients Receiving Clozapine
Acronym
APC
Official Title
Validation of Molecular Imaging Technologies for Early Clinical Trials
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
clozapine, PET, schizophrenia, schizoaffective disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
clozapine
Arm Type
Experimental
Arm Description
patients with refractory schizophrenia or schizoaffective disorder
Intervention Type
Drug
Intervention Name(s)
clozapine
Other Intervention Name(s)
clozaril
Intervention Description
C-11 clozapine
Primary Outcome Measure Information:
Title
pharmacodynamics of F-18 artanserin
Description
PET imaging with F-18 altanserin infusion
Time Frame
84 days
Secondary Outcome Measure Information:
Title
serum level of clozapine and metabolites
Description
dose-response relationship between clozapine and receptor occupancy
Time Frame
84 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae Seung Chang, MD, PhD
Phone
82 31 787 7437
Email
cjs0107@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Se Young Lee, MD
Phone
82 31 787 7439
Email
zoayo2000@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Seung Chang, MD, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Se Young Lee, MD
Phone
82 31 787 7439
Email
zoayo2000@hanmail.net
First Name & Middle Initial & Last Name & Degree
Kyooseob Ha, MD, PhD

12. IPD Sharing Statement

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F-18 Altanserin PET Study of Patients Receiving Clozapine

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