NCT02964923

Genes Polymorphisms and Metabolic Effects of the Second Generation Antipsychotic Drugs in Patients With Schizophrenia

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to investigate these effects of Second-Generation Antipsychotic (SGAs) on glucose and lipid metabolic parameters in patients with schizophrenia, and explore the relationship between genes polymorphisms (such as drug metabolic enzyme, Endogenous Cannabinoid Receptor Type 1(CB1) and so on) and the SGAs-induced glucose and lipid metabolic disorder in Chinese Han persons with schizophrenia who are taking one of the SGAs(olanzapine, risperidone or ziprasidone).

Detailed description

SGAs now is used as the main tool to treat schizophrenia, however，the mechanism of glucose and lipid metabolism disorder it brings is still unclear. Based on the previous studies, the investigators found that the CB1 gene has a close connection with the metabolism disorder.The investigators suppose that the CB1 also has a significant role in regulation of energy and metabolism in hypothalamus. In this study ,the investigators will recruit 300 Patients with schizophrenia who defined by Diagnostic and Statistical Manual-5 (DSM-5), aged 18 to 60,and all the participants will receive a 6-week systematic treatment by one of the SGAs(including olanzapine, risperidone oral solution, ziprasidone capsules), and a battery of assessments of treatment effect and safety. Plasma concentration will be tested regularly, and these genes polymorphisms of CB1 and other associated with energy metabolism will be conducted by the second generation of gene detection techniques.This study could provide evidence and data to achieve the aim of individualized medication, reduce the drugs' side effect, also throw light on the production of medication for correct the metabolism disorder.

Conditions

• Schizophrenia

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-06-01
• Completion: 2017-12-01
• First posted: 2016-11-16
• Last updated: 2016-11-16

Locations

1 site across 1 country: China