Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03007303
Other study ID # GFu01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 2016
Est. completion date July 2020

Study information

Verified date January 2020
Source Dalian Seventh People's Hospital
Contact Guanghui Fu, postgraduate
Phone 86-188 4282 1307
Email fuguanghui1023@126.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date July 2020
Est. primary completion date March 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 17 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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:
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

Locations

Country Name City State
China Dalian Seventh People's Hospital Dalian Liaoning

Sponsors (2)

Lead Sponsor Collaborator
Dalian Seventh People's Hospital TAKARA BIOTECHNOLOGY(DALIAN)CO.,LTD.

Country where clinical trial is conducted

China, 

References & Publications (3)

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 — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 before the treatment
Primary 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 Change from Baseline expression level at 4-week treatment
Primary 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 Change from Baseline expression level at 8-week treatment
Secondary 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 before, after 4 weeks and 8 weeks treatment
Secondary 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 before, after 4 weeks and 8 weeks treatment
Secondary 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 4 weeks and 8 weeks treatment
See also
  Status Clinical Trial Phase
Recruiting NCT05039489 - A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia N/A
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Completed NCT04503954 - Efficacy of Chronic Disease Self-management Program in People With Schizophrenia N/A
Completed NCT02831231 - Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium Phase 1
Completed NCT05517460 - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center N/A
Completed NCT03652974 - Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy Phase 4
Recruiting NCT04012684 - rTMS on Mismatch Negativity of Schizophrenia N/A
Recruiting NCT04481217 - Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia N/A
Completed NCT00212784 - Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935) Phase 3
Completed NCT04092686 - A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia Phase 3
Completed NCT01914393 - Pediatric Open-Label Extension Study Phase 3
Recruiting NCT03790345 - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics Phase 2/Phase 3
Recruiting NCT05956327 - Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training N/A
Terminated NCT03261817 - A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders N/A
Terminated NCT03209778 - Involuntary Memories Investigation in Schizophrenia N/A
Completed NCT02905604 - Magnetic Stimulation of the Brain in Schizophrenia or Depression N/A
Recruiting NCT05542212 - Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia N/A
Completed NCT04411979 - Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia N/A
Terminated NCT03220438 - TMS Enhancement of Visual Plasticity in Schizophrenia N/A