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The Potential Biomark of Serious Psychosis:a Prospective,Case-controled Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02202460
Recruitment Status : Unknown
Verified July 2014 by Renrong Wu, Central South University.
Recruitment status was:  Not yet recruiting
First Posted : July 29, 2014
Last Update Posted : July 29, 2014
Sponsor:
Information provided by (Responsible Party):
Renrong Wu, Central South University

Brief Summary:
Patients suffer from Serious Psychosis may have variation in immunological factors,BDNF and MRI.

Condition or disease
Other Immunological States or Disorders

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 18 Months
Official Title: The Potential Biomark of Serious Psychosis: Including the Variation of Brain MRI, BDNF and Oxidative Stress-related Immunological Factors in Different Phases.
Study Start Date : August 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. BDNF [ Time Frame: 18 month ]
    Collecting participants' blood every 3 month to assess the concentration of brain derived neurotrophic factor.


Other Outcome Measures:
  1. Brain MRI [ Time Frame: 18 month ]
    Brain MRI will be examined every 6 month or when onset syptoms are dramatically changed.


Biospecimen Retention:   Samples With DNA
blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Schizophrenia , Bipolar Disorder , Major Depression
Criteria

Inclusion Criteria:

  • Diagnosis with Schizophrenia , Bipolar Disorder or Major Depression by DSM-5

Exclusion Criteria:

  • Unstable physical conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202460


Contacts
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Contact: Renrong Wu, PhD +86 15874179855 wurenrong2013@163.com

Locations
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China, Hunan
Mental Health Institute of 2nd Xiangya Hospital,CSU
Changsha, Hunan, China, 410011
Contact: Renrong Wu, PhD    15874179855    wurenrong2013@163.com   
Sponsors and Collaborators
Central South University
Additional Information:

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Responsible Party: Renrong Wu, Professor, Central South University
ClinicalTrials.gov Identifier: NCT02202460    
Other Study ID Numbers: rrw2014
IFMISMD ( Registry Identifier: IFMISMD )
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: July 29, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders