Clinical trial NCT02964923: Genes Polymorphisms and Metabolic Effects of the Second Generation Antipsychotic Drugs in Patients With Schizophrenia
Official title: Genes Polymorphisms and Metabolic Effects of the Second Generation Antipsychotic Drugs in Patients With Schizophrenia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Keywords: Genetic polymorphism
Metabolic side effects of drugs
schizophrenia
Second-Generation Antipsychotic
Cannabinoid Receptor Type 1
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2016-11-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Chinese han patients with schizophrenia

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: measured at week 2
Secondary outcomes:
measure: identification of the change of the body mass index in patients with schizophrenia who are treated with the SGAs
timeFrame: measured at baseline、week 2 and 6
measure: 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
timeFrame: measured at baseline、week 2 and 6
measure: identification of the change of the level of lipid profile in patients with schizophrenia who are treated with the SGAs
timeFrame: measured at baseline、week 2 and 6
measure: identification of the change of the level of fasting insulin in patients with schizophrenia who are treated with the SGAs
timeFrame: measured at baseline、week 2 and 6
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of psychiatry，Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Department of Psychiatry,Xijing hospital,Xi'an,China
name: Huaning Wang, Ph.D
role: STUDY_CHAIR
affiliation: Department of Pharmacy,Xijing hospital,Xi'an,China
name: Zhifu Yang, Ph.D
role: STUDY_CHAIR
References: