F-18 Altanserin PET Study of Patients Receiving Clozapine
APC
Validation of Molecular Imaging Technologies for Early Clinical Trials
1 other identifier
interventional
12
1 country
1
Brief Summary
To examine the feasibility of molecular imaging markers in clinical psychopharmacology
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable schizophrenia
Started Jul 2011
Typical duration for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 19, 2011
CompletedFirst Posted
Study publicly available on registry
July 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedNovember 21, 2013
November 1, 2013
4 years
July 19, 2011
November 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pharmacodynamics of F-18 artanserin
PET imaging with F-18 altanserin infusion
84 days
Secondary Outcomes (1)
serum level of clozapine and metabolites
84 days
Study Arms (1)
clozapine
EXPERIMENTALpatients with refractory schizophrenia or schizoaffective disorder
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jae Seung Chang, MD, PhD
Seoul National University Bundang Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
July 19, 2011
First Posted
July 20, 2011
Study Start
July 1, 2011
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
November 21, 2013
Record last verified: 2013-11