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

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shanxi Medical University
• Treatments: Antipsychotic Agents; Aripiprazole; Olanzapine; Quetiapine Fumarate; Risperidone; Ziprasidone

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.