Clinical trial NCT03007303: The Relevance Between the microRNA-30e in Plasma and the Prognosis of Schizophrenia Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Micrognathia
Lead sponsor: Dalian Seventh People's Hospital
Sponsor class: OTHER
Collaborators: name: TAKARA BIOTECHNOLOGY(DALIAN)CO.,LTD.
First posted: 2017-01-02
Enrollment: 30
Sex: ALL
Minimum age (years): 17
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: the Baseline expression profiling of microRNA-30e measured by real-time quantitative poly-chain reaction (QPCR)
timeFrame: before the treatment
measure: the Changed expression level of microRNA-30e measured by real-time quantitative poly-chain reaction (QPCR)
timeFrame: Change from Baseline expression level at 4-week treatment
measure: the Changed expression level of microRNA-30e measured by real-time quantitative poly-chain reaction (QPCR)
timeFrame: Change from Baseline expression level at 8-week treatment
Secondary outcomes:
measure: the scores of Positive and Negative Syndrome Scale(PANSS) for the patients with schizophrenia
timeFrame: before, after 4 weeks and 8 weeks treatment
measure: The degree of Personal and Social Performance scale(PSP) for the patients with schizophrenia
timeFrame: before, after 4 weeks and 8 weeks treatment
measure: The scale of Clinical Global Impression(CGI) in patients with schizophrenia after treatment
timeFrame: 4 weeks and 8 weeks treatment
Other outcomes:
Locations:
city: Dalian
country: China
facility: Dalian Seventh People's Hospital
state: Liaoning
Study officials:
affiliation: Dalian Seventh People's Hospital
name: Shoufu Xie, postgraduate
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Xu 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.
citation: Banigan 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.