SchizophreniaAPCNCT01398189
F-18 Altanserin PET Study of Patients Receiving Clozapine
A study testing clozapine in people with Schizophrenia and Schizoaffective Disorder, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
To examine the feasibility of molecular imaging markers in clinical psychopharmacology Read more about this study
- Who is it for?
- Ages 19 to 45 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- clozapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2011to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Se Young Lee, MD, 82 31 787 7439, zoayo2000@hanmail.net
Kyooseob Ha, MD, PhD
About this study
Official title: Validation of Molecular Imaging Technologies for Early Clinical Trials
To examine the feasibility of molecular imaging markers in clinical psychopharmacology
Read the 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- clozapine
- Keywords
- clozapine, PET, schizophrenia, schizoaffective disorder
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clozapineDrug
Also called clozaril
C-11 clozapine
| Study group | Role | What they receive |
|---|---|---|
| clozapine | Experimental | patients with refractory schizophrenia or schizoaffective disorder Receives: Drug: clozapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacodynamics of F-18 artanserin
PET imaging with F-18 altanserin infusion
Measured: 84 days
Secondary outcomes (1)
serum level of clozapine and metabolites
dose-response relationship between clozapine and receptor occupancy
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae Seung Chang, Seoul National University Bundang Hospital
- Investigators
- Jae Seung Chang, MD, PhD, Study director, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398189
- Sponsor's protocol ID
- SNUBH 04-2011-050
- Acronym
- APC
- Status last verified
- Nov 2013
- First submitted
- 19 Jul 2011
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Molecular Imaging Technologies for Early Clinical Trials
- ClinicalTrials.gov ID
- NCT01398189
- Acronym / sponsor ID
- APC / SNUBH 04-2011-050
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- clozapine, PET, schizophrenia, schizoaffective disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 20 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| clozapine | Experimental | Drug: clozapinepatients with refractory schizophrenia or schizoaffective disorder |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clozapineAlso: clozarilC-11 clozapine | Drug | clozapine |
Primary outcome
pharmacodynamics of F-18 artanserin
Time frame: 84 days
PET imaging with F-18 altanserin infusion
1 secondary outcome
serum level of clozapine and metabolites
Time frame: 84 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae Seung Chang, MD, PhD study director
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clozapine in people with Schizophrenia and Schizoaffective Disorder, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae Seung Chang, MD, PhD (82 31 787 7437, cjs0107@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pharmacodynamics of F-18 artanserin (time frame: 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2013.