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

NCT02964923 | Unknown

• 1 other identifier: NSFC-81571309
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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).

Conditions

Schizophrenia

Keywords

Genetic polymorphism; Metabolic side effects of drugs; schizophrenia; Second-Generation Antipsychotic; Cannabinoid Receptor Type 1

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• identification of the change of the body mass index 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 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

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The Chinese han patients with schizophrenia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Department of psychiatry，Xijing Hospital

Xi'an, Shaanxi, 710000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Schizophrenia; Metabolic Side Effects of Drugs and Substances

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Officials

• 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

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 16, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 16, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)