- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03999931
Study on the Difference of Plasma microRNA Expression in Patients With Genetic Susceptibility to Mental Disorders
June 26, 2019 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
The Second Affiliated Hospital, Zhejiang University
Schizophrenia (Schizophrenia,Sc), biphasic affective disorder (Bipolar disorder,BPD), major depression (major depressive disorder,MDD), anxiety disorder (Anxiety disorder,An) and other mental disorders have obvious family aggregation, with heritability of 60 -90%.
This kind of common mental illness seriously affects the psychosomatic health and quality of life of patients, and places a great mental and economic burden on the society and family.
At present, the diagnosis of mental illness is mainly based on clinical symptoms.
With the development of molecular biology, genomics has become a new way to study mental illness.
MicroRNA (miRNA) is a class of eukaryotic endogenously non-coding single-stranded RNA, which can regulate gene expression by binding to specific mRNA or regulating the protein translation process of specific mRNA.
MiRNA widely exists in plasma and serum, and the type and quantity of miRNA in plasma and serum change with different physiological and disease conditions.
It is reported that the expression profile of miRNA in brain tissue of schizophrenia is significantly different from that of normal subjects.
In addition, the study found that the specific miRNA detected in peripheral blood can directly reflect the condition of the disease, which may use miRNA in peripheral blood as a clinical biological marker.
In order to detect the expression of various miRNA in plasma, high throughput miRNA chip detection has become the first choice for primary screening.
In this study, the investigators intend to detect the difference of miRNA expression in peripheral blood of different types of schizophrenia by high throughput miRNA chip, and analyze the correlation between them.
It is hoped to provide the basis for the diagnosis and occurrence and development of clinical psychotic patients.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
49
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
21 years to 66 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
From 2014 to 2016, 28 patients with mental disorders were enrolled in the second affiliated Hospital of Zhejiang University, aged 21 -66 years, with an average age of 42.0 years.
Description
Inclusion Criteria:
Meet the diagnostic criteria of DSM- V (see attached page for details); there is no history of blood transfusion within 1 month.
Exclusion Criteria:
Physical and nervous system diseases such as brain trauma; history of mental illness such as mental retardation; history of alcohol abuse and drug abuse.
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
Cohorts and Interventions
Group / Cohort |
---|
control
|
schizophrenia with positive symptoms
|
schizophrenia with negative symptoms
|
bipolar disorder
|
depression
|
panic disorder
|
obsessive-compulsive disorder
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The expression of mir-4687-3p in patients with PD is different from that in normal subjects.
Time Frame: July, 2016
|
The expression of mir-4687-3p in patients with PD is different from that in normal subjects.
|
July, 2016
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
January 1, 2014
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
December 31, 2015
Study Registration Dates
First Submitted
June 25, 2019
First Submitted That Met QC Criteria
June 26, 2019
First Posted (Actual)
June 27, 2019
Study Record Updates
Last Update Posted (Actual)
June 27, 2019
Last Update Submitted That Met QC Criteria
June 26, 2019
Last Verified
June 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-058
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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