SchizophreniaNCT02248987
Study on Abnormal Dopamine Synthesis and Connectivity According to the Antipsychotic Treatment Response in Schizophrenia
An observational study of Schizophrenia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate abnormal dopamine synthesis and connectivity according to the antipsychotic treatment response in schizophrenia. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- patients treated with antipsychotics
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to May 2016
- Phase
- Observational
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 1. Schizophrenia patients treated with clozapine 2. Schizophrenia patients treated with risperidone or paliperidone or olanzapine 3. Healthy volunteers
Who may be able to join
- diagnosis of schizophrenia
- clinically stable state
Who cannot join
- history of previous head injury, epileptic disorder, other medical comorbidity
- substance abuse/dependence
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate abnormal dopamine synthesis and connectivity according to the antipsychotic treatment response in schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- patients treated with antipsychotics
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients treated with antipsychoticsOther
| Study group | Role | What they receive |
|---|---|---|
| Clozapine | stable patients treated with clozapine Receives: Other: patients treated with antipsychotics | |
| Other antipsychotics | stable patients treated with risperidone or paliperidone or olanzapine Receives: Other: patients treated with antipsychotics | |
| Healthy volunteer | healthy controls Receives: Other: patients treated with antipsychotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Striatal [18F]-DOPA uptake measured using positron emission tomographic 18F-dopa imaging.
Measured: within 2 weeks from enrollment
Secondary outcomes (4)
resting state functional magnetic resonance imaging
Measured: within 2 weeks from enrollment
diffusion tensor imaging
Measured: within 2 weeks from enrollment
clinical measure including Positive and Negative Syndrome Scale
Measured: within 2 weeks from enrollment
neurocognitive function test
Measured: within 2 weeks from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2016
- Study completionMay 2016
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 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Soo Kwon, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248987
- Sponsor's protocol ID
- 3420130030
- Status last verified
- Apr 2019
- First submitted
- 22 Sep 2014
- Last updated
- 8 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Abnormal Dopamine Synthesis and Connectivity According to the Antipsychotic Treatment Response in Schizophrenia
- ClinicalTrials.gov ID
- NCT02248987
- Acronym / sponsor ID
- 3420130030
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 25 Sep 2014 (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.
The purpose of this study is to evaluate abnormal dopamine synthesis and connectivity according to the antipsychotic treatment response in schizophrenia.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clozapine | – | Other: patients treated with antipsychoticsstable patients treated with clozapine |
| Other antipsychotics | – | Other: patients treated with antipsychoticsstable patients treated with risperidone or paliperidone or olanzapine |
| Healthy volunteer | – | Other: patients treated with antipsychoticshealthy controls |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 1. Schizophrenia patients treated with clozapine 2. Schizophrenia patients treated with risperidone or paliperidone or olanzapine 3. Healthy volunteers
Key inclusion criteria (2 listed)
- diagnosis of schizophrenia
- clinically stable state
Key exclusion criteria (2 listed)
- history of previous head injury, epileptic disorder, other medical comorbidity
- substance abuse/dependence
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 |
|---|---|---|
| patients treated with antipsychotics | Other | Clozapine, Healthy volunteer, Other antipsychotics |
Primary outcome
Striatal [18F]-DOPA uptake measured using positron emission tomographic 18F-dopa imaging.
Time frame: within 2 weeks from enrollment
4 secondary outcomes
resting state functional magnetic resonance imaging
Time frame: within 2 weeks from enrollment
diffusion tensor imaging
Time frame: within 2 weeks from enrollment
clinical measure including Positive and Negative Syndrome Scale
Time frame: within 2 weeks from enrollment
neurocognitive function test
Time frame: within 2 weeks from enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Seoul National University 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 8 Apr 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Striatal [18F]-DOPA uptake measured using positron emission tomographic 18F-dopa imaging. (time frame: within 2 weeks from enrollment). 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 8 Apr 2019.