The Potential Biomark of Serious Psychosis:a Prospective,... | NCT02202460

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

NCT02202460

Sponsor

Central South University

Status

Unknown status

Last Update Posted

Jul 29, 2014Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Other Immunological States or Disorders

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IFMISMD	Registry Identifier	IFMISMD

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Jun 12, 2014

First Submission Date that Met QC Criteria

Jul 25, 2014

First Posted Date

Jul 29, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2014

Last Update Posted Date

Jul 29, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

18 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oxidative Stress-related Immunological Factors	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 Outcomes

Measure	Description	Time Frame
BDNF	Collecting participants' blood every 3 month to assess the concentration of brain derived neurotrophic factor.	18 month

Other Outcomes

Measure	Description	Time Frame
Brain MRI	Brain MRI will be examined every 6 month or when onset syptoms are dramatically changed.	18 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Unstable physical conditions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Schizophrenia , Bipolar Disorder , Major Depression

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Renrong Wu, PhD	Contact	+86 15874179855		wurenrong2013@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mental Health Institute of 2nd Xiangya Hospital,CSU		Changsha	Hunan	410011	China

Condition Browse Module

MeSH Terms

ID	Term
D004194	Disease

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided