Other Immunological States or DisordersNCT02202460
The Potential Biomark of Serious Psychosis:a Prospective,Case-controled Study
An observational study of Other Immunological States or Disorders, run by Central South University at 1 site in China.
Trial summary
Patients suffer from Serious Psychosis may have variation in immunological factors,BDNF and MRI. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Other Immunological States or Disorders
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Dec 2020
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Schizophrenia , Bipolar Disorder , Major Depression
Who may be able to join
- Diagnosis with Schizophrenia , Bipolar Disorder or Major Depression by DSM-5
Who cannot join
- Unstable physical conditions
Trial locations and contacts
1 site in 1 country.
China1 site
Mental Health Institute of 2nd Xiangya Hospital,CSU
Changsha, Hunan, 410011
Renrong Wu, PhD, 15874179855, wurenrong2013@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Other Immunological States or Disorders
- Medical subject headings
- Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 month
Secondary outcomes (1)
BDNF
Collecting participants' blood every 3 month to assess the concentration of brain derived neurotrophic factor.
Measured: 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Immunological States or DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renrong Wu, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202460
- Sponsor's protocol ID
- rrw2014
- Other IDs
- IFMISMD
- Status last verified
- Jul 2014
- First submitted
- 12 Jun 2014
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Biomark of Serious Psychosis: Including the Variation of Brain MRI, BDNF and Oxidative Stress-related Immunological Factors in Different Phases.
- ClinicalTrials.gov ID
- NCT02202460
- Acronym / sponsor ID
- rrw2014
- Conditions
- Other Immunological States or Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 29 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 18 Months
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Schizophrenia , Bipolar Disorder , Major Depression
Key inclusion criteria (1 listed)
- Diagnosis with Schizophrenia , Bipolar Disorder or Major Depression by DSM-5
Key exclusion criteria (1 listed)
- Unstable physical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
BDNF
Time frame: 18 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Other Immunological States or Disorders, run by Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Renrong Wu, PhD (+86 15874179855, wurenrong2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxidative Stress-related Immunological Factors (time frame: 18 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2014.