Biomarkers in First Episode Schizophrenia
Condition: Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder, Depressed Type
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Observational

Summary: 
      This study will identify and evaluate relevant biomarkers and structural brain imaging for
      understanding potential biological illness related mechanisms in medication-naïve subjects
      with early psychosis before and after initiation of antipsychotic medication
    

Detailed description: 
      It is currently unknown whether deterioration early in the course of psychotic illness
      represents medication toxicity or the natural course of the illness. The study will help
      clarify this issue in observing 70 schizophrenic patients before and after they are
      prescribed an antipsychotic via standard of care.

      In addition, schizophrenia is a heterogeneous disorder and a putative brain-derived
      neurotrophic factor (BDNF) deficit, while possibly a common pathway, may not fully capture
      the biological diversity-the supplemental biomarkers will allow us to perform a more
      comprehensive assessment of factors contributing to clinical course. Taken together analysis
      of these biomarkers in relation to clinical course and in relation to healthy subjects will
      inform us about biological mechanisms contributing to illness onset, effects of antipsychotic
      medication on these mechanisms, and the predictive value of the biomarkers for clinical
      course. This information will provide the foundation for future early intervention trials
      targeting biological mechanisms utilizing a personalized medicine approach.

      The baseline visit for 70 schizophrenic patients and 70 healthy age and gender matched
      controls consists of structural and functional MRI in addition to a blood draw for biomarkers
      including BDNF, inflammation markers, DNA, oxidative stress, and folate status and
      additionally a salivary cortisol sample collection. Biomarkers and imaging will be repeated
      after 8 weeks of antipsychotic treatment in patients.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be 70 patients, ages 15-40, with first episode schizophrenia or
        schizophreniform disorder with onset before age 35 who are medication naive and do not meet
        criteria for major depression or significant suicidal ideation or substance abuse (except
        nicotine) and 70 age and gender matched healthy controls. Subjects will be recruited by
        physicians in the Bellevue Hospital emergency room, outpatient clinic and on the Bellevue
        psychiatric inpatient units as well as through the inpatient / outpatient services at
        Shanghai Mental Health Center .

        Potential subjects will be identified by clinicians and asked whether they would like to
        speak to a researcher. Healthy subjects will be recruited through advertising by using a
        flyer.
      
Biospecimen description: 
      -  Whole Blood

        -  DNA

        -  Saliva

        -  Serum

        -  Plasma