The Relevance Between the microRNA-30e in Plasma and the Prognosis of Schizophrenia Patients
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|ClinicalTrials.gov Identifier: NCT03007303|
Recruitment Status : Recruiting
First Posted : January 2, 2017
Last Update Posted : February 2, 2018
|Condition or disease||Intervention/treatment|
|Schizophrenia Micrognathia||Drug: Atypical Antipsychotic Other: atypical antipsychotic combined with MECT|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||30 participants|
|Target Follow-Up Duration:||8 Weeks|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||July 2020|
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.
Drug: Atypical Antipsychotic
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.
Other Name: olanzapine, quetiapine , ziprasidone and risperidone
Other: atypical antipsychotic combined with MECT
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
Other Name: MECT means modified electric convulsive therapy
15 healthy individuals were collected from Dalian seventh people's hospital and were matched on age and sex to schizophrenia group
- 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
- 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 PANSS for estimating the severity of positive and negative symptoms in schizophrenia
- 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 degree of Personal and Social Performance scale(PSP) used to evaluate the disable levels in Multiple dimensions ,especially in social and self-care performance
- The scale of Clinical Global Impression(CGI) in patients with schizophrenia after treatment [ Time Frame: 4 weeks and 8 weeks treatment ]Main purpose to provide a global rating of illness severity ,improvement and response to treatment for the patients with schizophrenia
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03007303
|Contact: Guanghui Fu, postgraduate||86-188 4282 firstname.lastname@example.org|
|Contact: Shoufu Xie, postgraduate||86-0411 8451 email@example.com|
|Dalian Seventh People's Hospital||Recruiting|
|Dalian, Liaoning, China, 116023|
|Contact: Guanghui Fu, Postgraduate 86-188 4282 1307 firstname.lastname@example.org|
|Contact: Shoufu Xie, Postgraduate 86-0411 8451 4015 email@example.com|
|Principal Investigator:||Shoufu Xie, postgraduate||Dalian Seventh People's Hospital|