SchizophreniaNCT03007303
The Relevance Between the microRNA-30e in Plasma and the Prognosis of Schizophrenia Patients
An observational study of Schizophrenia and Micrognathia, run by Dalian Seventh People's Hospital at 1 site in China.
Trial summary
This study investigates the relationship of circulating microRNA-30e and schizophrenia, and shows the relevance of the aberrant microRNA-30e expression in plasma with the variation disease status. Read more about this study
- Who is it for?
- Ages 17 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Micrognathia
- What is being tested?
- Atypical Antipsychotic and atypical antipsychotic combined with MECT
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Jul 2020
- How long will I take part?
- 8 Weeks
- 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 17 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: the first-onset schizophrenia patients or drug-free suffers in the last 3 months，who are Chinese of Han descent and admitted to the Dalian Seventh People's Hospital,China
Who may be able to join
- Persons should be diagnosed with schizophrenia according to the International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10)
- The first-onset or drug-free in the latest 3 months
- Between the ages of 17-40
Who cannot join
- Comorbid with other psychosis
- Have physical or neurological diseases such as traumatic brain injuries
- History of drug-abused or alcoholic
- Blood transfusion history in a month
- Been treated with Modified Electric Convulsive Therapy(MECT) in late 3 months
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dalian Seventh People's Hospital
Dalian, Liaoning, 116023
Guanghui Fu, Postgraduate, 86-188 4282 1307, fuguanghui1023@126.com
Shoufu Xie, Postgraduate, 86-0411 8451 4015, doctorxie1023@126.com
About this study
This study investigates the relationship of circulating microRNA-30e and schizophrenia, and shows the relevance of the aberrant microRNA-30e expression in plasma with the variation disease status.
Read the detailed description
The plasma samples from 15 individuals with schizophrenia (with a diagnosis of ICD-10) and the equivalent healthy controls will be conducted with the quantification analysis of the microRNA-30e via real-time quantitative polymerase chain reaction(RT-PCR).
The 15 patients enrolled should be the first-episode and have not been treated, or were drug free 3 months recently at least.
This research measures the expression level of microRNA-30e in schizophrenia respectively before the beginning treatment with atypical psychotics or combined with MECT, after the 4-week treated , the 8-week treated compared with 15 healthy controls.
- Conditions
- Schizophrenia, Micrognathia
- Being tested
- Atypical Antipsychotic, atypical antipsychotic combined with MECT
- Medical subject headings
- Schizophrenia, Micrognathism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atypical AntipsychoticDrug
Also called olanzapine, quetiapine , ziprasidone and risperidone
Olanzapine: tablet ,5-20mg, Po q.d. Risperidone: tablet ,1-3 mg, Po q.d. Quetiapine: tablet ,100-400mg, Po b.i.d. ziprasidone : tablet ,40 -80mg, Po b.i.d.
atypical antipsychotic combined with MECTOther
Also called MECT means modified electric convulsive therapy
The schizophrenia who matches the indications such as severe negativism, refused to eating or stupor may be treated with antipsychotic combined with MECT, the frequency and times of MECT depend on the state of illness
| Study group | Role | What they receive |
|---|---|---|
| schizophrenia | 15 patients with schizophrenia will be treated with anyone of the atypical psychotics(including olanzapine, quetiapine , ziprasidone and risperidone)or combined with MECT.
The fluctuating dosage depends on the changes of symptom according to the total scores of Positive and Negative Syndrome Scale from schizophrenia patients after treated. Receives: Drug: Atypical Antipsychotic; Other: atypical antipsychotic combined with MECT | |
| health controls | 15 healthy individuals were collected from Dalian seventh people's hospital and were matched on age and sex to schizophrenia group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Baseline expression profiling of microRNA-30e measured by real-time quantitative poly-chain reaction (QPCR)
the plasma samples will be collected from the patients with schizophrenia and the healthy controls at the beginning recruit for the microRNA-30e detection
Measured: before the treatment
the Changed expression level of microRNA-30e measured by real-time quantitative poly-chain reaction (QPCR)
the plasma samples will be collected from the patients with schizophrenia at the 4-week treatment for the microRNA-30e detection
Measured: Change from Baseline expression level at 4-week treatment
the Changed expression level of microRNA-30e measured by real-time quantitative poly-chain reaction (QPCR)
the plasma samples will be collected from the patients with schizophrenia at the 8-week treatment for the microRNA-30e detection
Measured: Change from Baseline expression level at 8-week treatment
Secondary outcomes (3)
the scores of Positive and Negative Syndrome Scale(PANSS) for the patients with schizophrenia
The PANSS for estimating the severity of positive and negative symptoms in schizophrenia
Measured: before, after 4 weeks and 8 weeks treatment
The degree of Personal and Social Performance scale(PSP) for the patients with schizophrenia
The degree of Personal and Social Performance scale(PSP) used to evaluate the disable levels in Multiple dimensions ,especially in social and self-care performance
Measured: before, after 4 weeks and 8 weeks treatment
The scale of Clinical Global Impression(CGI) in patients with schizophrenia after treatment
Main purpose to provide a global rating of illness severity ,improvement and response to treatment for the patients with schizophrenia
Measured: 4 weeks and 8 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startJun 2016
- Primary completionMar 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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
- 30 participants (estimated)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- Dalian Seventh People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- TAKARA BIOTECHNOLOGY(DALIAN)CO.,LTD.
- Responsible party
- Principal investigator, Shoufu Xie, Dalian Seventh People's Hospital
- Investigators
- Shoufu Xie, postgraduate, Principal investigator, Dalian Seventh People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007303
- Sponsor's protocol ID
- GFu01
- Status last verified
- Jan 2020
- First submitted
- 17 Nov 2016
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Xu C, Liu X, Song X, Gao Q, Cheng L, Wang L, Zhang K, Xu Y. Aberrant resting state in microRNA-30e rat model of cognitive impairment. Neuroreport. 2016 Aug 3;27(11):809-17. doi: 10.1097/WNR.0000000000000616.
PubMed 27258654Xu Y, Li F, Zhang B, Zhang K, Zhang F, Huang X, Sun N, Ren Y, Sui M, Liu P. MicroRNAs and target site screening reveals a pre-microRNA-30e variant associated with schizophrenia. Schizophr Res. 2010 Jun;119(1-3):219-27. doi: 10.1016/j.schres.2010.02.1070. Epub 2010 Mar 27.
PubMed 20347265Banigan MG, Kao PF, Kozubek JA, Winslow AR, Medina J, Costa J, Schmitt A, Schneider A, Cabral H, Cagsal-Getkin O, Vanderburg CR, Delalle I. Differential expression of exosomal microRNAs in prefrontal cortices of schizophrenia and bipolar disorder patients. PLoS One. 2013;8(1):e48814. doi: 10.1371/journal.pone.0048814. Epub 2013 Jan 30.
PubMed 23382797
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relevance Between the microRNA-30e in Plasma and the Prognosis of Schizophrenia Patients
- ClinicalTrials.gov ID
- NCT03007303
- Acronym / sponsor ID
- GFu01
- Conditions
- Schizophrenia, Micrognathia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dalian Seventh People's HospitalUniversity, hospital or other
- Collaborators
- TAKARA BIOTECHNOLOGY(DALIAN)CO.,LTD.
- Study start
- Jun 2016
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 2 Jan 2017 (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.
This study investigates the relationship of circulating microRNA-30e and schizophrenia, and shows the relevance of the aberrant microRNA-30e expression in plasma with the variation disease status.
Detailed description
The plasma samples from 15 individuals with schizophrenia (with a diagnosis of ICD-10) and the equivalent healthy controls will be conducted with the quantification analysis of the microRNA-30e via real-time quantitative polymerase chain reaction(RT-PCR).
The 15 patients enrolled should be the first-episode and have not been treated, or were drug free 3 months recently at least.
This research measures the expression level of microRNA-30e in schizophrenia respectively before the beginning treatment with atypical psychotics or combined with MECT, after the 4-week treated , the 8-week treated compared with 15 healthy controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| schizophrenia | – | Drug: Atypical Antipsychotic, Other: atypical antipsychotic combined with MECT15 patients with schizophrenia will be treated with anyone of the atypical psychotics(including olanzapine, quetiapine , ziprasidone and risperidone)or combined with MECT. The fluctuating dosage depends on the changes of symptom according to the total scores of Positive and Negative Syndrome Scale from schizophrenia patients after treated. |
| health controls | – | –15 healthy individuals were collected from Dalian seventh people's hospital and were matched on age and sex to schizophrenia group |
Who may qualify
- Ages
- 17 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- the first-onset schizophrenia patients or drug-free suffers in the last 3 months，who are Chinese of Han descent and admitted to the Dalian Seventh People's Hospital,China
Key inclusion criteria (3 listed)
- Persons should be diagnosed with schizophrenia according to the International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10)
- The first-onset or drug-free in the latest 3 months
- Between the ages of 17-40
Key exclusion criteria (5 listed)
- Comorbid with other psychosis
- Have physical or neurological diseases such as traumatic brain injuries
- History of drug-abused or alcoholic
- Blood transfusion history in a month
- Been treated with Modified Electric Convulsive Therapy(MECT) in late 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atypical AntipsychoticAlso: olanzapine, quetiapine , ziprasidone and risperidoneOlanzapine: tablet ,5-20mg, Po q.d. Risperidone: tablet ,1-3 mg, Po q.d. Quetiapine: tablet ,100-400mg, Po b.i.d. ziprasidone : tablet ,40 -80mg, Po b.i.d. | Drug | schizophrenia |
| atypical antipsychotic combined with MECTAlso: MECT means modified electric convulsive therapyThe schizophrenia who matches the indications such as severe negativism, refused to eating or stupor may be treated with antipsychotic combined with MECT, the frequency and times of MECT depend on the state of illness | Other | schizophrenia |
Primary outcome
the Baseline expression profiling of microRNA-30e measured by real-time quantitative poly-chain reaction (QPCR)
Time frame: before the treatment
the plasma samples will be collected from the patients with schizophrenia and the healthy controls at the beginning recruit for the microRNA-30e detection
the Changed expression level of microRNA-30e measured by real-time quantitative poly-chain reaction (QPCR)
Time frame: Change from Baseline expression level at 4-week treatment
the plasma samples will be collected from the patients with schizophrenia at the 4-week treatment for the microRNA-30e detection
the Changed expression level of microRNA-30e measured by real-time quantitative poly-chain reaction (QPCR)
Time frame: Change from Baseline expression level at 8-week treatment
the plasma samples will be collected from the patients with schizophrenia at the 8-week treatment for the microRNA-30e detection
3 secondary outcomes
the scores of Positive and Negative Syndrome Scale(PANSS) for the patients with schizophrenia
Time frame: before, after 4 weeks and 8 weeks treatment
The degree of Personal and Social Performance scale(PSP) for the patients with schizophrenia
Time frame: before, after 4 weeks and 8 weeks treatment
The scale of Clinical Global Impression(CGI) in patients with schizophrenia after treatment
Time frame: 4 weeks and 8 weeks treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Results publication: PubMed 27258654Xu C, Liu X, Song X, Gao Q, Cheng L, Wang L, Zhang K, Xu Y. Aberrant resting state in microRNA-30e rat model of cognitive impairment. Neuroreport. 2016 Aug 3;27(11):809-17. doi: 10.1097/WNR.0000000000000616.
- Results publication: PubMed 20347265Xu Y, Li F, Zhang B, Zhang K, Zhang F, Huang X, Sun N, Ren Y, Sui M, Liu P. MicroRNAs and target site screening reveals a pre-microRNA-30e variant associated with schizophrenia. Schizophr Res. 2010 Jun;119(1-3):219-27. doi: 10.1016/j.schres.2010.02.1070. Epub 2010 Mar 27.
- Results publication: PubMed 23382797Banigan MG, Kao PF, Kozubek JA, Winslow AR, Medina J, Costa J, Schmitt A, Schneider A, Cabral H, Cagsal-Getkin O, Vanderburg CR, Delalle I. Differential expression of exosomal microRNAs in prefrontal cortices of schizophrenia and bipolar disorder patients. PLoS One. 2013;8(1):e48814. doi: 10.1371/journal.pone.0048814. Epub 2013 Jan 30.
- Individual participant dataSharing planned: Yes
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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.
Shoufu Xie, postgraduate principal investigator
Dalian Seventh People's Hospital
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 Schizophrenia and Micrognathia, run by Dalian Seventh People's Hospital 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 3 inclusion and 5 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 30 Jan 2020. 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 Guanghui Fu, postgraduate (86-188 4282 1307, fuguanghui1023@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Baseline expression profiling of microRNA-30e measured by real-time quantitative poly-chain reaction (QPCR) (time frame: before the treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03007303, which also lists 3 linked publications.
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 30 Jan 2020.