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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olanzapine group | Following the baseline assessment, subjects will enter an open treatment group with Olanzapine(Zyprexa) lasting 6 weeks. The subjects will start with a dose of 5-10mg/d , which would be adjusted to as low as 10 mg/d or as high as 20 mg/d, based on clinical response.And drug dose adjustments must be completed within 1 week. | ||
| Risperidone group | Following the baseline assessment, subjects will enter an open treatment group with Risperidone oral solution(Risperdal) lasting 6 weeks. The subjects will start with a dose of 1ml/d , which would be adjusted to as low as 4 ml/d or as high as 6 ml/d, based on clinical response.Drug dose adjustments interval is generally not less than 2 days, and should reach a effective dose of 4~6ml/d within 1 week. | ||
| Ziprasidone group | Following the baseline assessment, subjects will enter an open treatment group with Ziprasidone Hydrochloride Capsules(Zeldox) lasting 6 weeks. They started with a dose of 40mg/d , which would be adjusted to as low as 80mg/d or as high as 160/d, based on clinical response.Drug dose adjustments interval is generally not less than 2 days, and should reach a effective dose of 80~160mg/d within 10 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| identification of the effect of some genes polymorphism on the development of glucose and lipid metabolism disorder in patients with schizophrenia who are treated with the SGAs | measured at week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| identification of the change of the body mass index in patients with schizophrenia who are treated with the SGAs | the ration of participants who are total remission after treatment | measured at baseline、week 2 and 6 |
| identification of the change of the level of Fasting Blood Sugar (FBS), 2 hours post prandial (2HPP) in patients with schizophrenia who are treated with the SGAs |
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Inclusion Criteria:
Exclusion Criteria:
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The Chinese han patients with schizophrenia
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| Name | Affiliation | Role |
|---|---|---|
| Huaning Wang, Ph.D | Department of Psychiatry,Xijing hospital,Xi'an,China | Study Chair |
| Zhifu Yang, Ph.D | Department of Pharmacy,Xijing hospital,Xi'an,China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of psychiatry，Xijing Hospital | Xi'an | Shaanxi | 710000 | China |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D065606 | Metabolic Side Effects of Drugs and Substances |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
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whole blood
| measured at baseline、week 2 and 6 |
| identification of the change of the level of lipid profile in patients with schizophrenia who are treated with the SGAs | measured at baseline、week 2 and 6 |
| identification of the change of the level of fasting insulin in patients with schizophrenia who are treated with the SGAs | measured at baseline、week 2 and 6 |