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Identifying Factors That Affect Basic Symptoms of Psychosis

This study is currently recruiting participants.
Study NCT00291200.   Last updated on January 18, 2008.   Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Identifying Factors That Affect Basic Symptoms of Psychosis
Official Title  Enhancing the Prospective Prediction of Psychosis
Brief 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.

Study Phase
Study Type  Observational
Study Design  Case Control, Prospective
Primary Outcome Measure  Information on the natural history of basic symptoms of psychosis [ Time Frame: Measured monthly during Year 1; every 2 months during Year 2; and every 3 months during Years 3, 4, and 5 ] [ Designated as safety issue: No ]
Factors that may affect the improvement or persistence of basic symptoms of psychosis [ Time Frame: Measured monthly during Year 1; every 2 months during Year 2; and every 3 months during Years 3, 4, and 5 ] [ Designated as safety issue: No ]
Secondary Outcome Measure 
Condition  Schizophrenia
Psychotic Disorders
Intervention 
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  360
Start Date  August 2003
Completion Date March 2008
Eligibility Criteria 

Inclusion Criteria:

  • Meets modified criteria of prodromal syndromes (COPS) for schizophrenia prodrome or help-seeking control

Exclusion Criteria:

  • History of psychosis
  • Antipsychotic treatment in the month prior to study entry
  • More than 16 weeks of lifetime antipsychotic treatment
Gender Both
Ages 12 Years to 35 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Elizabeth Cook     919-843-3421     Elizabeth_Cook@med.unc.edu    
Location Countries  United States,   Canada
Administrative Information Fields
NCT ID  NCT00291200
Organization ID MH61282
Secondary IDs †† DATR AD-P
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Scott W. Woods, MD     Yale School of Medicine    
Principal Investigator:     Jean Addington, PhD     University of Toronto    
Principal Investigator:     Diana O. Perkins, MD, MPH     University of North Carolina    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date January 2008
First Received Date  February 10, 2006
Last Updated Date January 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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