Second-Generation Antipsychotic Treatment Indication Effectiveness And Tolerability In Youth (Satiety) Study
Condition: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Psychotic Disorder, Not Otherwise Specified; Prodromal Schizophrenia; Mood Disorder; Bipolar Disorder; Major Depressive Disorder; Depressive Disorder, Not Otherwise Specified; Mood Disorder, Not Otherwise Specified; Autism Spectrum Disorder
MeSH terms: Schizophrenia; Depressive Disorder; Depression; Depressive Disorder, Major; Bipolar Disorder; Autism Spectrum Disorder; Psychotic Disorders; Mood Disorders
Study type: Observational

Summary: 
      The purpose of this study is to get a better understanding of the side effect burden and
      identify predictors of psychotic, mood and aggressive disorders in children and adolescents.
      The study's primary aim is to identify genetic risk factors for weight gain and metabolic
      abnormalities.
    

Detailed description: 
      Participants will be evaluated for biological and genetic risk factors for nutritional and
      metabolic adverse effects associated with SGAPs (second generation antipsychotics) during 4
      visits over 12 weeks. Participants will also be evaluated at month 6, 9, and 12. This study
      does not involve treatment for participants. Treatment of subjects enrolled in this study
      will be determined by their clinician and will remain unaffected by participation in this
      observational minimal risk study.

      All participants were prescribed risperidone (Risperdal) for the duration of study
      participation and doses ranged from 0.25mg to 6mg daily for 52 weeks.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The investigators aim to recruit 200 individuals between the ages of 3 and 19, from a
        diverse range of ethnic and racial backgrounds, who have a clinical diagnosis of psychotic
        disorders, mood disorder or an autism spectrum disorder and are considered for treatment
        with second generation antipsychotic (SGAP) medication by a physician.

        Every effort will be made to recruit participants of all ethnicities, races and genders.
        The investigators will specifically target recruitment efforts toward minorities by using
        minority media and informational liaison with community organizations that serve minority
        populations.
      
Biospecimen description: 
      fasting glucose, lipid profile, insulin, leptin, prolactin, AST, ALT, CRP, adiponectin,
      ghrelin, cortisol, and relevant cytokines or peptide hormones (e.g., NP-Y, resistin,
      TNF-alpha, IL-1b, IL-2, IL-6, IL-8, IL-12, IL-18), sex hormones (e.g., testosterone,
      dehydroepiandrosterone, estrogen, luteinizing hormone, follicle stimulating hormone, and sex
      hormone binding globulin), and SGAP level (not baseline), to assure compliance. TSH and CBC
      will be measured at baseline only.

      Each subject will be asked to provide an additional 16 ml blood sample (approximately 1
      tablespoon) for DNA collection and genotyping.
    
Keywords: Second Generation Antipsychotics; Schizophrenia; Schizoaffective; Schizophreniform; Psychosis NOS; Mood Disorders; Weight; Autism