Enhancing the Prospective Prediction of Psychosis
Condition: Schizophrenia; Psychotic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders
Study type: Observational

Summary: 
      This study will gather information on the natural history of the basic symptoms of psychosis
      to identify factors that may affect the improvement or persistence of the symptoms.
    

Detailed description: 
      Psychosis is a serious mental condition in which a person momentarily loses contact with
      reality. People in a state of psychosis may experience hallucinations or delusional beliefs
      that make day-to-day functioning difficult. During the early development of psychosis, people
      undergo an initial change in mood, thinking, or behavior that may include making mistakes
      about smells, sounds, or sights; becoming easily distracted; and developing suspicions of
      others. These basic symptoms can be early warning signs of a brain disorder, including
      anxiety disorder, depression, or psychotic disorder. Basic symptoms may be due to a number of
      factors, including a reaction to stress or drugs or just a part of normal adolescence. To
      identify psychosis early and accurately, more information is needed on the initial stages,
      biological markers, and progression of psychosis. This study will gather information on the
      natural history of the basic symptoms of psychosis to identify factors that may affect the
      improvement or persistence of the symptoms.

      Participation in this study will last up to 5 years. The initial screening visit will be used
      to determine whether a participant is eligible for the group displaying basic symptoms or the
      control group. Initial screening will include giving a blood sample for routine lab tests, a
      physical exam, a drug test, and questions about medical history and symptoms. All
      participants will then partake in baseline evaluations, which involve assessments concerning
      concentration, problem solving, memory, social skills, and ability to identify smells.
      Participants will also respond to questions about symptoms, school and social functioning,
      stressful situations, and family history of illnesses. The participants who meet the criteria
      for basic symptoms will attend monthly 1-hour follow-up visits for the first year of the
      study. During these visits, participants will be asked about the status of their basic
      symptoms and use of medications. For the second year of the study, follow-up visits will
      occur every 2 months, and for the third, fourth, and fifth years of the study, visits will be
      every 3 months. Repeat baseline assessments will occur every 6 months, with each assessment
      visit lasting about 5 hours. All participants will undergo endpoint evaluations that follow
      the same format as most baseline assessments. Participants who develop a psychotic disorder
      during the study will attend an additional follow-up visit 6 months after the endpoint
      evaluation to confirm diagnosis. Participants who decide that they no longer wish to attend
      regular study visits may be asked to participate in follow-up telephone interviews about
      their basic symptoms every 6 months.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population consists of participants who meet the basic symptoms for psychosis and
        control participants recruited at three sites: the PRIME Clinics at University of North
        Carolina, Yale University, and the Center for Addiction and Mental Health (CAMH) in
        Toronto, Canada.
      
Biospecimen description: 
      Blood samples for routine laboratory studies
    
Keywords: Psychosis; Basic Symptoms