5-HTR2A, DRD2,and COMT Genes Polymorphisms and Olanzapine Plasma Concentration in Treatment of Early-onset Schizophrenia
Condition: Early-onset Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study,investigators will recruit 100 DSM-Ⅴdefined EOS Han patients, older than 7
      years old and onset of illness before 17 years old, and all EOS patients will receive a
      8-week systematic olanzepine titration treatment and a battery of assessments of treatment
      effect and safety. Blood olanzepine plasma concentration will be tested regularly and
      genotyping of 8 polymorphisms of 5-HTR2A, DRD2 and COMT genes will be conducted by Polymerase
      Chain Reaction （PCR）, Restriction Fragment Length Polymorphism (RFLP) and TaqMan probes
      genotyping technology. The aim of the study is to explore the predictive factors on
      olanzepine treatment response in EOS, which can guide the individualized treatment and
      improve the cure rate of EOS in clinical setting.
    

Detailed description: 
      Early-onset schizophrenia (EOS) is the World Health Organization ranked psychosis as the
      third most disabling condition worldwide in youth, and may lead to obvious social dysfunction
      and interfere seriously with neurodevelopmental processes in a young person, which in turn
      has the potential to irreversibly alter the trajectory of his or her life. To improve the
      outcome of the patients of EOS, elaborate and individualized therapeutic regimen is urgently
      needed. The functional gene polymorphisms and drug (antipsychotics) plasma concentration can
      both influence the drug response, but few studies explore the contributions of genetic
      heterogeneity, drug plasma concentration and clinical features of patients to drug response
      together and interactions of above factors in EOS patients. In this study investigators will
      recruit 100 DSM-Ⅴdefined EOS Han patients, older than 7 years old and onset of illness before
      17 years old, and all EOS patients will receive a 8-week systematic olanzepine titration
      treatment and a battery of assessments of treatment effect and safety. Blood olanzepine
      plasma concentration will be tested regularly and genotyping of 8 polymorphisms of 5-HTR2A,
      DRD2 and COMT genes will be conducted by Polymerase Chain Reaction （PCR）, Restriction
      Fragment Length Polymorphism (RFLP) and TaqMan probes genotyping technology. The aim of the
      study is to explore the predictive factors on olanzepine treatment response in EOS, which can
      guide the individualized treatment and improve the cure rate of EOS in clinical setting.
    

Intervention name(s): olanzapine
Intervention type(s): Drug
Intervention description(s): olanzapine will be initiated at 2.5 or 5 mg/day according to patient's weight, and the dose could be increased by 2.5 or 5 mg every 4-7days at the investigator's discretion.A effective dose would be titrated in two weeks with no tolerability or safety issues are apparent,
Other intervention name(s): Zyprexa
Intervention MeSH terms: Olanzapine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Genes Polymorphisms; Plasma Concentration