- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01398189
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
Conditions
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
- Name: Se Young Lee, MD
- Phone Number: 82 31 787 7439
- Email: zoayo2000@hanmail.net
Study Locations
-
-
Gyeonggi
-
Seongnam, Gyeonggi, Korea, Republic of, 463-707
- Recruiting
- Seoul National University Bundang Hospital
-
Contact:
- Se Young Lee, MD
- Phone Number: 82 31 787 7439
- Email: zoayo2000@hanmail.net
-
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:
|
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
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Psychotic Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Serotonin Antagonists
- GABA Agents
- GABA Antagonists
- Clozapine
Other Study ID Numbers
- SNUBH 04-2011-050
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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