Schizophrenia Clinical Trial
Official title:
Genes Polymorphisms and Metabolic Effects of the Second Generation Antipsychotic Drugs in Patients With Schizophrenia
Verified date | November 2016 |
Source | Xijing Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
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).
Status | Active, not recruiting |
Enrollment | 300 |
Est. completion date | December 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - All cases must be in accordance with the DSM-5 schizophrenia or schizophreniform disorder diagnosis standards - Negative and positive symptom scale(PANSS)score = 60 points;Aged 18 to 60 - Did not participate diet or other body mass reduction projects - Did not have physical illness which affects diet or activities - Did not use any antipsychotic drug within 2 weeks - Subject to consent by the Ethics Committee on clinical trials of drugs,Xijing hospital of The Fourth Military Medical University , all the participants signed a written informed consent Exclusion Criteria: - Pregnant or lactating women - Patients with serious body disease, such as epilepsy, liver and kidney impairment, digestive system diseases, etc - Obvious abnormalities on physical and laboratory examination - Body mass index(BMI)=25.0;Fasting plasma glucose(FPG)=6.1mmol/L or/and 2-hour postprandial blood glucose(2hPG)=7.8mmol/L or/and somebody has been diagnosed with diabetes and treatment;Fasting triglycerides=2.2mmol/L - Suffering from other mental disorders in line with DSM-5 diagnostic criteria |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
China | Department of psychiatry,Xijing Hospital | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Xijing Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | 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 | Yes |
Secondary | 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 | measured at baseline?week 2 and 6 | Yes | |
Secondary | 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 | Yes | |
Secondary | 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 | Yes |
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