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

Other Immunological States or Disorders Clinical Trial

Official title:

The Potential Biomark of Serious Psychosis: Including the Variation of Brain MRI, BDNF and Oxidative Stress-related Immunological Factors in Different Phases.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02202460
• Other study ID #: rrw2014
• Secondary ID: IFMISMD
• Status: Not yet recruiting
• Phase: N/A
• First received: June 12, 2014
• Last updated: July 25, 2014
• Start date: August 2014
• Est. completion date: December 2020

Study information

• Verified date: July 2014
• Source: Central South University
• Contact: Renrong Wu, PhD
• Phone: +86 15874179855
• Email: wurenrong2013[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2020
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Unstable physical conditions

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Other Immunological States or Disorders

Locations

Country	Name	City	State
China	Mental Health Institute of 2nd Xiangya Hospital,CSU	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Brain MRI	Brain MRI will be examined every 6 month or when onset syptoms are dramatically changed.	18 month	Yes
Primary	Oxidative Stress-related Immunological Factors	Blood test will be conducted every 3 month to assess the concentration of oxidative stress-related immunological factors including TNFa,TGFß, MCP-1,IL-1a,IL-2,IL-6,IL-10,IL-12.	18 month	Yes
Secondary	BDNF	Collecting participants' blood every 3 month to assess the concentration of brain derived neurotrophic factor.	18 month	Yes