The Role of miR-30 Family Dysregulation in Response to Antipsychotic Treatment

NCT02650102 | Unknown Phase 1 DMC

• 1 other identifier: 81571319
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aberrant expression of micro-RNAs (miRNAs) has been described in many human diseases, including schizophrenia (SZ). The previous work has indicated a strong genetic association between the miRNA-30e precursor (pre-miR-30e) and the risk of SZ. However, to date, few reports have focused on the expression level of the miR-30 family (miR-30s) and its networks of co-regulation in SZ, even in response to antipsychotic treatment. Given this, the investigator first constructed a hybrid miRNA-TF (transcription factor)-gene-PPI (protein-protein interactions) network focusing on miR-30s by bioinformatics technology. The investigator then selected several candidate miR-30s and key regulators for further validation. These candidates were then quantified by real-time quantitative PCR (qRT-PCR) in an independent cohort of 200 healthy controls and 200 drug-free SZ patients, among which were followed up by 12-week antipsychotic treatment. Furthermore, the investigator evaluated the correlation between the change in gene expression and the improvement of symptoms.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Number of schizophrenics with antipsychptic treatment who achieved remission assessed by PANSS.

  The clinical effects were assessed by trained and experienced psychiatrists with the Positive and Negative Syndrome Scale (PANSS) before and after 12-week treatment.

  Number of schizophrenics with 12-week antipsychptic treatment who achieved remission assessed by PANSS.

Study Arms (2)

antipsychotics

EXPERIMENTAL

This group was treated with one of 5 antipsychotics(risperidone/olanzapine/aripiprazole/quetiapine/ziprasidone) randomly.

Drug: Risperidone; Drug: Olanzapine; Drug: Quetiapine; Drug: Aripiprazole; Drug: Ziprasidone

health control

NO INTERVENTION

This group was treated with no invention

Interventions

Risperidone DRUG

a kind of antipsychotics

Also known as: Risperdal

antipsychotics

Olanzapine DRUG

a kind of antipsychotics

Also known as: Zyprexa

antipsychotics

Quetiapine DRUG

a kind of antipsychotics

Also known as: Seroquel

antipsychotics

Aripiprazole DRUG

a kind of antipsychotics

Also known as: Abilifya

antipsychotics

Ziprasidone DRUG

a kind of antipsychotics

Also known as: Geodon

antipsychotics

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Unrelated Han Chinese recruited from the north of China.
• Drug-free for at least one month before enrollment.
• Clinical diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for SZ (American Psychiatric Association, 1994), relying on the Chinese Version of the Modified Structured Clinical Interview for DSM-IV TR Axis I Disorders Patient Edition (SCID-I/P,11/2002 revision).

You may not qualify if:

• Pregnant or had significant medical conditions.
• Unstable psychiatric features (e.g., suicidal feelings).
• A history of substance abuse or drug addiction within the previous 6 months, with the exception of nicotine dependence.
• Other Axis I co-morbid disorders were not excluded.

Sponsors & Collaborators

• Shanxi Medical University: lead

Study Sites (1)

First Clinical Medical College of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Risperidone; Olanzapine; Quetiapine Fumarate; Aripiprazole; ziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Piperazines; Quinolones; Quinolines

Study Officials

• Yong Xu, Doctor

  Shanxi Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Xu, Doctor

CONTACT

18234016125; xuyongsmu@vip.163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Yong Xu

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 8, 2016
• Study Start: January 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 8, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)