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Trial record 52 of 3310 for:    schizophrenia

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

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ClinicalTrials.gov Identifier: NCT02964923
Recruitment Status : Unknown
Verified November 2016 by Xijing Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 16, 2016
Last Update Posted : November 16, 2016
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

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).

Condition or disease
Schizophrenia

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Time Perspective: Prospective
Official Title: Genes Polymorphisms and Metabolic Effects of the Second Generation Antipsychotic Drugs in Patients With Schizophrenia
Study Start Date : April 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  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 [ Time Frame: measured at week 2 ]

Secondary Outcome Measures :
  1. identification of the change of the body mass index in patients with schizophrenia who are treated with the SGAs [ Time Frame: measured at baseline、week 2 and 6 ]
    the ration of participants who are total remission after treatment

  2. 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 [ Time Frame: measured at baseline、week 2 and 6 ]
  3. identification of the change of the level of lipid profile in patients with schizophrenia who are treated with the SGAs [ Time Frame: measured at baseline、week 2 and 6 ]
  4. identification of the change of the level of fasting insulin in patients with schizophrenia who are treated with the SGAs [ Time Frame: measured at baseline、week 2 and 6 ]

Biospecimen Retention:   Samples With DNA
whole blood


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The Chinese han patients with schizophrenia
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02964923


Locations
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China, Shaanxi
Department of psychiatry,Xijing Hospital
Xi'an, Shaanxi, China, 710000
Sponsors and Collaborators
Xijing Hospital
Investigators
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Study Chair: 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

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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT02964923     History of Changes
Other Study ID Numbers: NSFC-81571309
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Xijing Hospital:
Genetic polymorphism
Metabolic side effects of drugs
schizophrenia
Second-Generation Antipsychotic
Cannabinoid Receptor Type 1
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents