Plasma microRNA in Patients With Genetic Susceptibility to Mental DisordersNCT03999931
Study on the Difference of Plasma microRNA Expression in Patients With Genetic Susceptibility to Mental Disorders
An observational study of Plasma microRNA in Patients With Genetic Susceptibility to Mental Disorders, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
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%. Read more about this study
- Who is it for?
- Ages 21 to 66 yearsHealthy volunteers can take part
- Conditions the study is for
- Plasma microRNA in Patients With Genetic Susceptibility to Mental Disorders
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 31 Dec 2015
- 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 21 to 66 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Meet the diagnostic criteria of DSM- V (see attached page for details); there is no history of blood transfusion within 1 month.
Who cannot join
- Physical and nervous system diseases such as brain trauma; history of mental illness such as mental retardation; history of alcohol abuse and drug abuse.
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| schizophrenia with positive symptoms | schizophrenia with positive symptoms | |
| schizophrenia with negative symptoms | schizophrenia with negative symptoms | |
| bipolar disorder | bipolar disorder | |
| depression | depression | |
| panic disorder | panic disorder | |
| obsessive-compulsive disorder | obsessive-compulsive disorder | |
| control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The expression of mir-4687-3p in patients with PD is different from that in normal subjects.
The expression of mir-4687-3p in patients with PD is different from that in normal subjects.
Measured: July, 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start1 Jan 2014
- Primary completion1 Jan 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma microRNA in Patients With Genetic Susceptibility to Mental 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
- Other
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999931
- Sponsor's protocol ID
- 2013-058
- Status last verified
- Jun 2016
- First submitted
- 25 Jun 2019
- Last updated
- 27 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Second Affiliated Hospital, Zhejiang University
- ClinicalTrials.gov ID
- NCT03999931
- Acronym / sponsor ID
- 2013-058
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 27 Jun 2019 (actual)
- 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.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| schizophrenia with positive symptoms | – | –schizophrenia with positive symptoms |
| schizophrenia with negative symptoms | – | –schizophrenia with negative symptoms |
| bipolar disorder | – | –bipolar disorder |
| depression | – | –depression |
| panic disorder | – | –panic disorder |
| obsessive-compulsive disorder | – | –obsessive-compulsive disorder |
| control | – | – |
Who may qualify
- Ages
- 21 to 66 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Meet the diagnostic criteria of DSM- V (see attached page for details); there is no history of blood transfusion within 1 month.
Key exclusion criteria (1 listed)
- Physical and nervous system diseases such as brain trauma; history of mental illness such as mental retardation; history of alcohol abuse and drug abuse.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Plasma microRNA in Patients With Genetic Susceptibility to Mental Disorders, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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: finished, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The expression of mir-4687-3p in patients with PD is different from that in normal subjects. (time frame: July, 2016). 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 27 Jun 2019.