- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02202460
The Potential Biomark of Serious Psychosis:a Prospective,Case-controled Study
July 25, 2014 updated by: Renrong Wu, Central South University
The Potential Biomark of Serious Psychosis: Including the Variation of Brain MRI, BDNF and Oxidative Stress-related Immunological Factors in Different Phases.
Patients suffer from Serious Psychosis may have variation in immunological factors,BDNF and MRI.
Study Overview
Status
Unknown
Conditions
Detailed Description
Patients suffer from Schizophrenia and Mood Disorders may have variation in immunological factors(TNF-α,IL-2,IL-6,IL-10,etc),BDNF and Brain MRI.
Study Type
Observational
Enrollment (Anticipated)
200
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
-
-
Hunan
-
Changsha, Hunan, China, 410011
- Mental Health Institute of 2nd Xiangya Hospital,CSU
-
-
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Schizophrenia , Bipolar Disorder , Major Depression
Description
Inclusion Criteria:
- Diagnosis with Schizophrenia , Bipolar Disorder or Major Depression by DSM-5
Exclusion Criteria:
- Unstable physical conditions
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oxidative Stress-related Immunological Factors
Time Frame: 18 month
|
Blood test will be conducted every 3 month to assess the concentration of oxidative stress-related immunological factors including TNFα,TGFβ, MCP-1,IL-1α,IL-2,IL-6,IL-10,IL-12.
|
18 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BDNF
Time Frame: 18 month
|
Collecting participants' blood every 3 month to assess the concentration of brain derived neurotrophic factor.
|
18 month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brain MRI
Time Frame: 18 month
|
Brain MRI will be examined every 6 month or when onset syptoms are dramatically changed.
|
18 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
August 1, 2014
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
June 12, 2014
First Submitted That Met QC Criteria
July 25, 2014
First Posted (Estimate)
July 29, 2014
Study Record Updates
Last Update Posted (Estimate)
July 29, 2014
Last Update Submitted That Met QC Criteria
July 25, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- rrw2014
- IFMISMD (Registry Identifier: IFMISMD)
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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