- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02248987
Study on Abnormal Dopamine Synthesis and Connectivity According to the Antipsychotic Treatment Response in Schizophrenia
April 4, 2019 updated by: Jun Soo Kwon, Seoul National University Hospital
The purpose of this study is to evaluate abnormal dopamine synthesis and connectivity according to the antipsychotic treatment response in schizophrenia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
36
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Seoul National University Hospital
-
-
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
20 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
- Schizophrenia patients treated with clozapine
- Schizophrenia patients treated with risperidone or paliperidone or olanzapine
- Healthy volunteers
Description
Inclusion Criteria:
- diagnosis of schizophrenia
- clinically stable state
Exclusion Criteria:
- history of previous head injury, epileptic disorder, other medical comorbidity
- substance abuse/dependence
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
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Clozapine
stable patients treated with clozapine
|
|
Other antipsychotics
stable patients treated with risperidone or paliperidone or olanzapine
|
|
Healthy volunteer
healthy controls
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Striatal [18F]-DOPA uptake measured using positron emission tomographic 18F-dopa imaging.
Time Frame: within 2 weeks from enrollment
|
within 2 weeks from enrollment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
resting state functional magnetic resonance imaging
Time Frame: within 2 weeks from enrollment
|
within 2 weeks from enrollment
|
diffusion tensor imaging
Time Frame: within 2 weeks from enrollment
|
within 2 weeks from enrollment
|
clinical measure including Positive and Negative Syndrome Scale
Time Frame: within 2 weeks from enrollment
|
within 2 weeks from enrollment
|
neurocognitive function test
Time Frame: within 2 weeks from enrollment
|
within 2 weeks from enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
May 1, 2014
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
September 22, 2014
First Submitted That Met QC Criteria
September 22, 2014
First Posted (Estimate)
September 25, 2014
Study Record Updates
Last Update Posted (Actual)
April 8, 2019
Last Update Submitted That Met QC Criteria
April 4, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3420130030
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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